Tabletcoating
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Tablet coating V.MANIMARAN LECTURER DEPARTMENT OF PHARMACEUTICS SRM COLLEGE OF PHARMACY UNIT IV
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Transcript of Tabletcoating
Tablet coating VMANIMARANLECTURERDEPARTMENT OF PHARMACEUTICSSRM COLLEGE OF PHARMACY
UNIT IV
INTRODUCTION
Coated tablets are defined as ldquotablets covered with one or more layers of mixture of various substances such as
Natural Or Synthetic ResinsGums Inactive And Insoluble Filler SugarPlasticizerPolyhydric Alcohol Waxes Authorized Colouring Material And Some Times Flavoring Material
I TherapyAvoid irritation of oesophagus and
stomachAvoid bad tasteAvoid inactivation of drug in the
stomachImprove drug effectivenessProlong dosing intervalImprove dosing intervalImprove patient compliance
Aspects of tablet coating
Aspects of tablet coating
II Technology
Reduce influence of moistureAvoid dust formationReduce influence of atmosphereImprove drug stabilityProlong shelve life
Aspects of tablet coating
III MarketingAvoid bad tasteImprove product identityImprove appearance and acceptability
Tablet coating is the application of coating composition to moving bed of tablets with concurrent use of heated air to facilitate evaporation of solvent
Basic principle of tablet coating
Type of tablet coating
bull Sugar coating
bull Film coating
bull Enteric coating
bull Controlled release coating
bull Specialized coating
Compressed coating
Electrostatic coating
Dip coating
Vacuum film coating
MANUFACTURE OF PHARMACEUTICAL TABLET COATING
EQUIPMENTS FOR TABLET COATING
Three general types of equipments are available
1Standard coating pan
eg Pellegrino pan systemImmersion sword systemImmersion tube system
2Perforated pan system
egAccela cota systemHicoater system
Glattcoater systemDriacoated system
3Fluidized bed coater
POLISHING
Standard Coating Pan
Immersion-tube system
Glatt Immersion
sword system
Pellegrini pan system
STANDARD COATING PAN
PERFORATED PANS
Accela cota system
Hi-coater system
PERFORATED PANS (continuehellip)
Dria coater pan
Glatt coater
FLUID BED COATING SYSTEMS
1 Film coating
2 Sugar coating
3 Press coating
Main coating processes
6 Printing5 Polishing4 Colouring3 Smoothing2 Sub coating1 Seal tablet core
bull Traditionally sugar coatings formed the bulk of coated tablets but today filmcoatings are the more modern technology in tablet coating
bull Description of tablets Smooth rounded and polished to a high glossbull Process Multistage Process involving 6 separate operations
Example of sugar coated tablets
Sugar coating
MULTISTAGE PROCESS
1 Sealing tablet core- application of a water impermeablepolymer such as Shellac cellulose acetate phthalate andpolyvinyl acetate phthalate which protects the core frommoisture increasing its shelf life
2 Sub coating -by adding bulking agents such as calciumcarbonate or talc in combination with sucrose solution
3 Smoothing process -remove rough layers formed in step2 with the application of sucrose syrup
4 Colouring - for aesthetic purposes often titanium basedpigments are included
5 Polishing - effectively polished to give characteristic shinecommonly using beeswax carnauba wax
6 Printing -indelible ink for characterisation
1- Sealing (Waterproofing)This involved the application of one or more coats of awaterproofing substance in the form of alcoholic spray such as pharmaceutical Shellac (traditionally) or syntheticpolymers such as CAP( Unless a modified-release feature needs to be introduced the amount of the sealing coat applied should be carefully calculated so that there is no negative effect on the drug release characteristics in case of immediate release product)
(WHY Sealing)a- Sugar-coatings are aqueous formulations which allowwater to penetrate directly into the tablet core and thuspotentially affecting product stability and possibly causingpremature tablet disintegrationb- Application of many coats of partially or completelywater-insoluble polymers in this step enables sugar-coatedproduct to exhibit modified-release pattern (extendedreleaseor delayed enteric- release characteristics)
2 Subcoatingbull - Large quantities of sugar-coatings are usually
applied to the tablet core (typically increasing the tablet weight by ( 50- 100)
WHY bull In order to round off the tablet edge Much of
this material build-up occurs during this stage and is achieved by adding a bulking agent such as Calcium carbonate to the sucrose solution
bull - Antiadherents eg Talc may be added after partial drying to prevent sticking of the tablets together
3- Smoothingbull The subcoating stage results in tablets with rough
surfaces To facilitate the color application (which requires smooth surface) subcoated tablets are smoothed out by a thick sucrose syrup coating
4- Coloringbull Color coatings usually consist of thin sucrose
syrup containing the requisite coloring materials (water-soluble dyes or water-insoluble pigments may be used) This step must be done into a clean pan deprived of any residues from the previous operations
5- Polishingbull After the coloring step the tablet surfaces tend to
be smooth but somewhat dull in appearance To achieve glossy finish final stage involving application of waxes (beeswax carnuba wax) is employed
6- Printingbull Different tablets could be identified by
manufacturer logo product name dosage strength or other appropriate code For sugar-coated tablets such identification could be only achieved by printing process using special edible inks
Brufenreg POMbull Available in 200mg and 400mg
strength
Premarinreg POMbull Conjugated oestrogens 625mcg
(maroon) and 125mcg (yellow)
Colofac reg Pbull Mebeverine hydrochloride
100mg Round white sugar coated
Kalms reg GSLbull 45mg Hops powder90mg
Gentian powdered extract and 135mg Valerian powdered extract
EXAMPLE OF SUGAR COATED TABLETS
SUGAR COATED PROCESS
bull Modern approach to coating tablets capsules or pellets bysurrounding them with a thin layer of polymeric material
bull Description of tablets Shape dictated by contour oforiginal core
bull Process Single stage process which involves spraying acoating solution containing the following
1 Polymer2 Solvent3 Plasticizer4 Colourant
The solution is sprayed onto a rotating tablet bed followedby drying which facilitates the removal of the solventleaving behind the deposition of thin film of coatingmaterials around each tablet
FILM COATING
AdvantagesProduce tablets in a single step process in
relatively short period of time Process enablesfunctional coatings to be incorporated into thedosage form
DisadvantagesThere are environmental and safety
implications of using organic solvent as well astheir financial expense
Types of film coating
A Immediate release
B Modified release
1Polymer
2PlasticizersPlasticizers are generally added to film coating formulations
to modify the physical properties of the polymer to make it
more usable One important property is their ability to
decrease film brittleness
Examples of plasticizers arepolyols such as polyethylene glycol 400
organic esters such as diethyl phthalate
oilsglycerides such as fractionated coconut oil
In general only water-miscible plasticizers can be used for aqueous-based
spray systems
31
3ColourantsAny permitted colourants in a film coat formula are invariably
water-insoluble colours (pigments) Pigments have certain
advantages over water-soluble colours they tend to be more
chemically stable towards light provide better opacity and
covering power and optimize the impermeability of a given film
to water vapour
Examples of colourants arebull iron oxide pigmentsbull titanium dioxidebull aluminum Lakes
32
4SolventsModern techniques now rely on water as a
polymer solvent because of the significant
drawbacks that readily became apparent with
the use of organic solvents
33
Nonentericmaterials eg
Hydroxypropyl methylcellulose (HPMC)Methylhydroxy ethyl cellulose (MHEC)Ethylcellulose (EC)Hydroxypropyl cellulose (HPC)Polyvinyl pyrrolidone (PVP)Sodium carboxymethyl cellulose (Sod CMC)Polyethylene glycols (PEG)Acrylate polymers eg Eudragit E
Enteric materials eg
Cellulose acetate phthalate (CAP)Acrylate polymers (Eudragit L S)Hydroxypropyl methylcellulose phthalate (HPMCP)Polyvinyl acetate phthalate (PVAP)
MATERIAL USED FOR FILM COATING
The vast majority of film coated tablets are produced by a process whichinvolves spraying of the coating material on to a bed of tablets AccelaCota is one example of equipment used for film coating
Accela Cota
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
INTRODUCTION
Coated tablets are defined as ldquotablets covered with one or more layers of mixture of various substances such as
Natural Or Synthetic ResinsGums Inactive And Insoluble Filler SugarPlasticizerPolyhydric Alcohol Waxes Authorized Colouring Material And Some Times Flavoring Material
I TherapyAvoid irritation of oesophagus and
stomachAvoid bad tasteAvoid inactivation of drug in the
stomachImprove drug effectivenessProlong dosing intervalImprove dosing intervalImprove patient compliance
Aspects of tablet coating
Aspects of tablet coating
II Technology
Reduce influence of moistureAvoid dust formationReduce influence of atmosphereImprove drug stabilityProlong shelve life
Aspects of tablet coating
III MarketingAvoid bad tasteImprove product identityImprove appearance and acceptability
Tablet coating is the application of coating composition to moving bed of tablets with concurrent use of heated air to facilitate evaporation of solvent
Basic principle of tablet coating
Type of tablet coating
bull Sugar coating
bull Film coating
bull Enteric coating
bull Controlled release coating
bull Specialized coating
Compressed coating
Electrostatic coating
Dip coating
Vacuum film coating
MANUFACTURE OF PHARMACEUTICAL TABLET COATING
EQUIPMENTS FOR TABLET COATING
Three general types of equipments are available
1Standard coating pan
eg Pellegrino pan systemImmersion sword systemImmersion tube system
2Perforated pan system
egAccela cota systemHicoater system
Glattcoater systemDriacoated system
3Fluidized bed coater
POLISHING
Standard Coating Pan
Immersion-tube system
Glatt Immersion
sword system
Pellegrini pan system
STANDARD COATING PAN
PERFORATED PANS
Accela cota system
Hi-coater system
PERFORATED PANS (continuehellip)
Dria coater pan
Glatt coater
FLUID BED COATING SYSTEMS
1 Film coating
2 Sugar coating
3 Press coating
Main coating processes
6 Printing5 Polishing4 Colouring3 Smoothing2 Sub coating1 Seal tablet core
bull Traditionally sugar coatings formed the bulk of coated tablets but today filmcoatings are the more modern technology in tablet coating
bull Description of tablets Smooth rounded and polished to a high glossbull Process Multistage Process involving 6 separate operations
Example of sugar coated tablets
Sugar coating
MULTISTAGE PROCESS
1 Sealing tablet core- application of a water impermeablepolymer such as Shellac cellulose acetate phthalate andpolyvinyl acetate phthalate which protects the core frommoisture increasing its shelf life
2 Sub coating -by adding bulking agents such as calciumcarbonate or talc in combination with sucrose solution
3 Smoothing process -remove rough layers formed in step2 with the application of sucrose syrup
4 Colouring - for aesthetic purposes often titanium basedpigments are included
5 Polishing - effectively polished to give characteristic shinecommonly using beeswax carnauba wax
6 Printing -indelible ink for characterisation
1- Sealing (Waterproofing)This involved the application of one or more coats of awaterproofing substance in the form of alcoholic spray such as pharmaceutical Shellac (traditionally) or syntheticpolymers such as CAP( Unless a modified-release feature needs to be introduced the amount of the sealing coat applied should be carefully calculated so that there is no negative effect on the drug release characteristics in case of immediate release product)
(WHY Sealing)a- Sugar-coatings are aqueous formulations which allowwater to penetrate directly into the tablet core and thuspotentially affecting product stability and possibly causingpremature tablet disintegrationb- Application of many coats of partially or completelywater-insoluble polymers in this step enables sugar-coatedproduct to exhibit modified-release pattern (extendedreleaseor delayed enteric- release characteristics)
2 Subcoatingbull - Large quantities of sugar-coatings are usually
applied to the tablet core (typically increasing the tablet weight by ( 50- 100)
WHY bull In order to round off the tablet edge Much of
this material build-up occurs during this stage and is achieved by adding a bulking agent such as Calcium carbonate to the sucrose solution
bull - Antiadherents eg Talc may be added after partial drying to prevent sticking of the tablets together
3- Smoothingbull The subcoating stage results in tablets with rough
surfaces To facilitate the color application (which requires smooth surface) subcoated tablets are smoothed out by a thick sucrose syrup coating
4- Coloringbull Color coatings usually consist of thin sucrose
syrup containing the requisite coloring materials (water-soluble dyes or water-insoluble pigments may be used) This step must be done into a clean pan deprived of any residues from the previous operations
5- Polishingbull After the coloring step the tablet surfaces tend to
be smooth but somewhat dull in appearance To achieve glossy finish final stage involving application of waxes (beeswax carnuba wax) is employed
6- Printingbull Different tablets could be identified by
manufacturer logo product name dosage strength or other appropriate code For sugar-coated tablets such identification could be only achieved by printing process using special edible inks
Brufenreg POMbull Available in 200mg and 400mg
strength
Premarinreg POMbull Conjugated oestrogens 625mcg
(maroon) and 125mcg (yellow)
Colofac reg Pbull Mebeverine hydrochloride
100mg Round white sugar coated
Kalms reg GSLbull 45mg Hops powder90mg
Gentian powdered extract and 135mg Valerian powdered extract
EXAMPLE OF SUGAR COATED TABLETS
SUGAR COATED PROCESS
bull Modern approach to coating tablets capsules or pellets bysurrounding them with a thin layer of polymeric material
bull Description of tablets Shape dictated by contour oforiginal core
bull Process Single stage process which involves spraying acoating solution containing the following
1 Polymer2 Solvent3 Plasticizer4 Colourant
The solution is sprayed onto a rotating tablet bed followedby drying which facilitates the removal of the solventleaving behind the deposition of thin film of coatingmaterials around each tablet
FILM COATING
AdvantagesProduce tablets in a single step process in
relatively short period of time Process enablesfunctional coatings to be incorporated into thedosage form
DisadvantagesThere are environmental and safety
implications of using organic solvent as well astheir financial expense
Types of film coating
A Immediate release
B Modified release
1Polymer
2PlasticizersPlasticizers are generally added to film coating formulations
to modify the physical properties of the polymer to make it
more usable One important property is their ability to
decrease film brittleness
Examples of plasticizers arepolyols such as polyethylene glycol 400
organic esters such as diethyl phthalate
oilsglycerides such as fractionated coconut oil
In general only water-miscible plasticizers can be used for aqueous-based
spray systems
31
3ColourantsAny permitted colourants in a film coat formula are invariably
water-insoluble colours (pigments) Pigments have certain
advantages over water-soluble colours they tend to be more
chemically stable towards light provide better opacity and
covering power and optimize the impermeability of a given film
to water vapour
Examples of colourants arebull iron oxide pigmentsbull titanium dioxidebull aluminum Lakes
32
4SolventsModern techniques now rely on water as a
polymer solvent because of the significant
drawbacks that readily became apparent with
the use of organic solvents
33
Nonentericmaterials eg
Hydroxypropyl methylcellulose (HPMC)Methylhydroxy ethyl cellulose (MHEC)Ethylcellulose (EC)Hydroxypropyl cellulose (HPC)Polyvinyl pyrrolidone (PVP)Sodium carboxymethyl cellulose (Sod CMC)Polyethylene glycols (PEG)Acrylate polymers eg Eudragit E
Enteric materials eg
Cellulose acetate phthalate (CAP)Acrylate polymers (Eudragit L S)Hydroxypropyl methylcellulose phthalate (HPMCP)Polyvinyl acetate phthalate (PVAP)
MATERIAL USED FOR FILM COATING
The vast majority of film coated tablets are produced by a process whichinvolves spraying of the coating material on to a bed of tablets AccelaCota is one example of equipment used for film coating
Accela Cota
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
I TherapyAvoid irritation of oesophagus and
stomachAvoid bad tasteAvoid inactivation of drug in the
stomachImprove drug effectivenessProlong dosing intervalImprove dosing intervalImprove patient compliance
Aspects of tablet coating
Aspects of tablet coating
II Technology
Reduce influence of moistureAvoid dust formationReduce influence of atmosphereImprove drug stabilityProlong shelve life
Aspects of tablet coating
III MarketingAvoid bad tasteImprove product identityImprove appearance and acceptability
Tablet coating is the application of coating composition to moving bed of tablets with concurrent use of heated air to facilitate evaporation of solvent
Basic principle of tablet coating
Type of tablet coating
bull Sugar coating
bull Film coating
bull Enteric coating
bull Controlled release coating
bull Specialized coating
Compressed coating
Electrostatic coating
Dip coating
Vacuum film coating
MANUFACTURE OF PHARMACEUTICAL TABLET COATING
EQUIPMENTS FOR TABLET COATING
Three general types of equipments are available
1Standard coating pan
eg Pellegrino pan systemImmersion sword systemImmersion tube system
2Perforated pan system
egAccela cota systemHicoater system
Glattcoater systemDriacoated system
3Fluidized bed coater
POLISHING
Standard Coating Pan
Immersion-tube system
Glatt Immersion
sword system
Pellegrini pan system
STANDARD COATING PAN
PERFORATED PANS
Accela cota system
Hi-coater system
PERFORATED PANS (continuehellip)
Dria coater pan
Glatt coater
FLUID BED COATING SYSTEMS
1 Film coating
2 Sugar coating
3 Press coating
Main coating processes
6 Printing5 Polishing4 Colouring3 Smoothing2 Sub coating1 Seal tablet core
bull Traditionally sugar coatings formed the bulk of coated tablets but today filmcoatings are the more modern technology in tablet coating
bull Description of tablets Smooth rounded and polished to a high glossbull Process Multistage Process involving 6 separate operations
Example of sugar coated tablets
Sugar coating
MULTISTAGE PROCESS
1 Sealing tablet core- application of a water impermeablepolymer such as Shellac cellulose acetate phthalate andpolyvinyl acetate phthalate which protects the core frommoisture increasing its shelf life
2 Sub coating -by adding bulking agents such as calciumcarbonate or talc in combination with sucrose solution
3 Smoothing process -remove rough layers formed in step2 with the application of sucrose syrup
4 Colouring - for aesthetic purposes often titanium basedpigments are included
5 Polishing - effectively polished to give characteristic shinecommonly using beeswax carnauba wax
6 Printing -indelible ink for characterisation
1- Sealing (Waterproofing)This involved the application of one or more coats of awaterproofing substance in the form of alcoholic spray such as pharmaceutical Shellac (traditionally) or syntheticpolymers such as CAP( Unless a modified-release feature needs to be introduced the amount of the sealing coat applied should be carefully calculated so that there is no negative effect on the drug release characteristics in case of immediate release product)
(WHY Sealing)a- Sugar-coatings are aqueous formulations which allowwater to penetrate directly into the tablet core and thuspotentially affecting product stability and possibly causingpremature tablet disintegrationb- Application of many coats of partially or completelywater-insoluble polymers in this step enables sugar-coatedproduct to exhibit modified-release pattern (extendedreleaseor delayed enteric- release characteristics)
2 Subcoatingbull - Large quantities of sugar-coatings are usually
applied to the tablet core (typically increasing the tablet weight by ( 50- 100)
WHY bull In order to round off the tablet edge Much of
this material build-up occurs during this stage and is achieved by adding a bulking agent such as Calcium carbonate to the sucrose solution
bull - Antiadherents eg Talc may be added after partial drying to prevent sticking of the tablets together
3- Smoothingbull The subcoating stage results in tablets with rough
surfaces To facilitate the color application (which requires smooth surface) subcoated tablets are smoothed out by a thick sucrose syrup coating
4- Coloringbull Color coatings usually consist of thin sucrose
syrup containing the requisite coloring materials (water-soluble dyes or water-insoluble pigments may be used) This step must be done into a clean pan deprived of any residues from the previous operations
5- Polishingbull After the coloring step the tablet surfaces tend to
be smooth but somewhat dull in appearance To achieve glossy finish final stage involving application of waxes (beeswax carnuba wax) is employed
6- Printingbull Different tablets could be identified by
manufacturer logo product name dosage strength or other appropriate code For sugar-coated tablets such identification could be only achieved by printing process using special edible inks
Brufenreg POMbull Available in 200mg and 400mg
strength
Premarinreg POMbull Conjugated oestrogens 625mcg
(maroon) and 125mcg (yellow)
Colofac reg Pbull Mebeverine hydrochloride
100mg Round white sugar coated
Kalms reg GSLbull 45mg Hops powder90mg
Gentian powdered extract and 135mg Valerian powdered extract
EXAMPLE OF SUGAR COATED TABLETS
SUGAR COATED PROCESS
bull Modern approach to coating tablets capsules or pellets bysurrounding them with a thin layer of polymeric material
bull Description of tablets Shape dictated by contour oforiginal core
bull Process Single stage process which involves spraying acoating solution containing the following
1 Polymer2 Solvent3 Plasticizer4 Colourant
The solution is sprayed onto a rotating tablet bed followedby drying which facilitates the removal of the solventleaving behind the deposition of thin film of coatingmaterials around each tablet
FILM COATING
AdvantagesProduce tablets in a single step process in
relatively short period of time Process enablesfunctional coatings to be incorporated into thedosage form
DisadvantagesThere are environmental and safety
implications of using organic solvent as well astheir financial expense
Types of film coating
A Immediate release
B Modified release
1Polymer
2PlasticizersPlasticizers are generally added to film coating formulations
to modify the physical properties of the polymer to make it
more usable One important property is their ability to
decrease film brittleness
Examples of plasticizers arepolyols such as polyethylene glycol 400
organic esters such as diethyl phthalate
oilsglycerides such as fractionated coconut oil
In general only water-miscible plasticizers can be used for aqueous-based
spray systems
31
3ColourantsAny permitted colourants in a film coat formula are invariably
water-insoluble colours (pigments) Pigments have certain
advantages over water-soluble colours they tend to be more
chemically stable towards light provide better opacity and
covering power and optimize the impermeability of a given film
to water vapour
Examples of colourants arebull iron oxide pigmentsbull titanium dioxidebull aluminum Lakes
32
4SolventsModern techniques now rely on water as a
polymer solvent because of the significant
drawbacks that readily became apparent with
the use of organic solvents
33
Nonentericmaterials eg
Hydroxypropyl methylcellulose (HPMC)Methylhydroxy ethyl cellulose (MHEC)Ethylcellulose (EC)Hydroxypropyl cellulose (HPC)Polyvinyl pyrrolidone (PVP)Sodium carboxymethyl cellulose (Sod CMC)Polyethylene glycols (PEG)Acrylate polymers eg Eudragit E
Enteric materials eg
Cellulose acetate phthalate (CAP)Acrylate polymers (Eudragit L S)Hydroxypropyl methylcellulose phthalate (HPMCP)Polyvinyl acetate phthalate (PVAP)
MATERIAL USED FOR FILM COATING
The vast majority of film coated tablets are produced by a process whichinvolves spraying of the coating material on to a bed of tablets AccelaCota is one example of equipment used for film coating
Accela Cota
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
Aspects of tablet coating
II Technology
Reduce influence of moistureAvoid dust formationReduce influence of atmosphereImprove drug stabilityProlong shelve life
Aspects of tablet coating
III MarketingAvoid bad tasteImprove product identityImprove appearance and acceptability
Tablet coating is the application of coating composition to moving bed of tablets with concurrent use of heated air to facilitate evaporation of solvent
Basic principle of tablet coating
Type of tablet coating
bull Sugar coating
bull Film coating
bull Enteric coating
bull Controlled release coating
bull Specialized coating
Compressed coating
Electrostatic coating
Dip coating
Vacuum film coating
MANUFACTURE OF PHARMACEUTICAL TABLET COATING
EQUIPMENTS FOR TABLET COATING
Three general types of equipments are available
1Standard coating pan
eg Pellegrino pan systemImmersion sword systemImmersion tube system
2Perforated pan system
egAccela cota systemHicoater system
Glattcoater systemDriacoated system
3Fluidized bed coater
POLISHING
Standard Coating Pan
Immersion-tube system
Glatt Immersion
sword system
Pellegrini pan system
STANDARD COATING PAN
PERFORATED PANS
Accela cota system
Hi-coater system
PERFORATED PANS (continuehellip)
Dria coater pan
Glatt coater
FLUID BED COATING SYSTEMS
1 Film coating
2 Sugar coating
3 Press coating
Main coating processes
6 Printing5 Polishing4 Colouring3 Smoothing2 Sub coating1 Seal tablet core
bull Traditionally sugar coatings formed the bulk of coated tablets but today filmcoatings are the more modern technology in tablet coating
bull Description of tablets Smooth rounded and polished to a high glossbull Process Multistage Process involving 6 separate operations
Example of sugar coated tablets
Sugar coating
MULTISTAGE PROCESS
1 Sealing tablet core- application of a water impermeablepolymer such as Shellac cellulose acetate phthalate andpolyvinyl acetate phthalate which protects the core frommoisture increasing its shelf life
2 Sub coating -by adding bulking agents such as calciumcarbonate or talc in combination with sucrose solution
3 Smoothing process -remove rough layers formed in step2 with the application of sucrose syrup
4 Colouring - for aesthetic purposes often titanium basedpigments are included
5 Polishing - effectively polished to give characteristic shinecommonly using beeswax carnauba wax
6 Printing -indelible ink for characterisation
1- Sealing (Waterproofing)This involved the application of one or more coats of awaterproofing substance in the form of alcoholic spray such as pharmaceutical Shellac (traditionally) or syntheticpolymers such as CAP( Unless a modified-release feature needs to be introduced the amount of the sealing coat applied should be carefully calculated so that there is no negative effect on the drug release characteristics in case of immediate release product)
(WHY Sealing)a- Sugar-coatings are aqueous formulations which allowwater to penetrate directly into the tablet core and thuspotentially affecting product stability and possibly causingpremature tablet disintegrationb- Application of many coats of partially or completelywater-insoluble polymers in this step enables sugar-coatedproduct to exhibit modified-release pattern (extendedreleaseor delayed enteric- release characteristics)
2 Subcoatingbull - Large quantities of sugar-coatings are usually
applied to the tablet core (typically increasing the tablet weight by ( 50- 100)
WHY bull In order to round off the tablet edge Much of
this material build-up occurs during this stage and is achieved by adding a bulking agent such as Calcium carbonate to the sucrose solution
bull - Antiadherents eg Talc may be added after partial drying to prevent sticking of the tablets together
3- Smoothingbull The subcoating stage results in tablets with rough
surfaces To facilitate the color application (which requires smooth surface) subcoated tablets are smoothed out by a thick sucrose syrup coating
4- Coloringbull Color coatings usually consist of thin sucrose
syrup containing the requisite coloring materials (water-soluble dyes or water-insoluble pigments may be used) This step must be done into a clean pan deprived of any residues from the previous operations
5- Polishingbull After the coloring step the tablet surfaces tend to
be smooth but somewhat dull in appearance To achieve glossy finish final stage involving application of waxes (beeswax carnuba wax) is employed
6- Printingbull Different tablets could be identified by
manufacturer logo product name dosage strength or other appropriate code For sugar-coated tablets such identification could be only achieved by printing process using special edible inks
Brufenreg POMbull Available in 200mg and 400mg
strength
Premarinreg POMbull Conjugated oestrogens 625mcg
(maroon) and 125mcg (yellow)
Colofac reg Pbull Mebeverine hydrochloride
100mg Round white sugar coated
Kalms reg GSLbull 45mg Hops powder90mg
Gentian powdered extract and 135mg Valerian powdered extract
EXAMPLE OF SUGAR COATED TABLETS
SUGAR COATED PROCESS
bull Modern approach to coating tablets capsules or pellets bysurrounding them with a thin layer of polymeric material
bull Description of tablets Shape dictated by contour oforiginal core
bull Process Single stage process which involves spraying acoating solution containing the following
1 Polymer2 Solvent3 Plasticizer4 Colourant
The solution is sprayed onto a rotating tablet bed followedby drying which facilitates the removal of the solventleaving behind the deposition of thin film of coatingmaterials around each tablet
FILM COATING
AdvantagesProduce tablets in a single step process in
relatively short period of time Process enablesfunctional coatings to be incorporated into thedosage form
DisadvantagesThere are environmental and safety
implications of using organic solvent as well astheir financial expense
Types of film coating
A Immediate release
B Modified release
1Polymer
2PlasticizersPlasticizers are generally added to film coating formulations
to modify the physical properties of the polymer to make it
more usable One important property is their ability to
decrease film brittleness
Examples of plasticizers arepolyols such as polyethylene glycol 400
organic esters such as diethyl phthalate
oilsglycerides such as fractionated coconut oil
In general only water-miscible plasticizers can be used for aqueous-based
spray systems
31
3ColourantsAny permitted colourants in a film coat formula are invariably
water-insoluble colours (pigments) Pigments have certain
advantages over water-soluble colours they tend to be more
chemically stable towards light provide better opacity and
covering power and optimize the impermeability of a given film
to water vapour
Examples of colourants arebull iron oxide pigmentsbull titanium dioxidebull aluminum Lakes
32
4SolventsModern techniques now rely on water as a
polymer solvent because of the significant
drawbacks that readily became apparent with
the use of organic solvents
33
Nonentericmaterials eg
Hydroxypropyl methylcellulose (HPMC)Methylhydroxy ethyl cellulose (MHEC)Ethylcellulose (EC)Hydroxypropyl cellulose (HPC)Polyvinyl pyrrolidone (PVP)Sodium carboxymethyl cellulose (Sod CMC)Polyethylene glycols (PEG)Acrylate polymers eg Eudragit E
Enteric materials eg
Cellulose acetate phthalate (CAP)Acrylate polymers (Eudragit L S)Hydroxypropyl methylcellulose phthalate (HPMCP)Polyvinyl acetate phthalate (PVAP)
MATERIAL USED FOR FILM COATING
The vast majority of film coated tablets are produced by a process whichinvolves spraying of the coating material on to a bed of tablets AccelaCota is one example of equipment used for film coating
Accela Cota
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
Aspects of tablet coating
III MarketingAvoid bad tasteImprove product identityImprove appearance and acceptability
Tablet coating is the application of coating composition to moving bed of tablets with concurrent use of heated air to facilitate evaporation of solvent
Basic principle of tablet coating
Type of tablet coating
bull Sugar coating
bull Film coating
bull Enteric coating
bull Controlled release coating
bull Specialized coating
Compressed coating
Electrostatic coating
Dip coating
Vacuum film coating
MANUFACTURE OF PHARMACEUTICAL TABLET COATING
EQUIPMENTS FOR TABLET COATING
Three general types of equipments are available
1Standard coating pan
eg Pellegrino pan systemImmersion sword systemImmersion tube system
2Perforated pan system
egAccela cota systemHicoater system
Glattcoater systemDriacoated system
3Fluidized bed coater
POLISHING
Standard Coating Pan
Immersion-tube system
Glatt Immersion
sword system
Pellegrini pan system
STANDARD COATING PAN
PERFORATED PANS
Accela cota system
Hi-coater system
PERFORATED PANS (continuehellip)
Dria coater pan
Glatt coater
FLUID BED COATING SYSTEMS
1 Film coating
2 Sugar coating
3 Press coating
Main coating processes
6 Printing5 Polishing4 Colouring3 Smoothing2 Sub coating1 Seal tablet core
bull Traditionally sugar coatings formed the bulk of coated tablets but today filmcoatings are the more modern technology in tablet coating
bull Description of tablets Smooth rounded and polished to a high glossbull Process Multistage Process involving 6 separate operations
Example of sugar coated tablets
Sugar coating
MULTISTAGE PROCESS
1 Sealing tablet core- application of a water impermeablepolymer such as Shellac cellulose acetate phthalate andpolyvinyl acetate phthalate which protects the core frommoisture increasing its shelf life
2 Sub coating -by adding bulking agents such as calciumcarbonate or talc in combination with sucrose solution
3 Smoothing process -remove rough layers formed in step2 with the application of sucrose syrup
4 Colouring - for aesthetic purposes often titanium basedpigments are included
5 Polishing - effectively polished to give characteristic shinecommonly using beeswax carnauba wax
6 Printing -indelible ink for characterisation
1- Sealing (Waterproofing)This involved the application of one or more coats of awaterproofing substance in the form of alcoholic spray such as pharmaceutical Shellac (traditionally) or syntheticpolymers such as CAP( Unless a modified-release feature needs to be introduced the amount of the sealing coat applied should be carefully calculated so that there is no negative effect on the drug release characteristics in case of immediate release product)
(WHY Sealing)a- Sugar-coatings are aqueous formulations which allowwater to penetrate directly into the tablet core and thuspotentially affecting product stability and possibly causingpremature tablet disintegrationb- Application of many coats of partially or completelywater-insoluble polymers in this step enables sugar-coatedproduct to exhibit modified-release pattern (extendedreleaseor delayed enteric- release characteristics)
2 Subcoatingbull - Large quantities of sugar-coatings are usually
applied to the tablet core (typically increasing the tablet weight by ( 50- 100)
WHY bull In order to round off the tablet edge Much of
this material build-up occurs during this stage and is achieved by adding a bulking agent such as Calcium carbonate to the sucrose solution
bull - Antiadherents eg Talc may be added after partial drying to prevent sticking of the tablets together
3- Smoothingbull The subcoating stage results in tablets with rough
surfaces To facilitate the color application (which requires smooth surface) subcoated tablets are smoothed out by a thick sucrose syrup coating
4- Coloringbull Color coatings usually consist of thin sucrose
syrup containing the requisite coloring materials (water-soluble dyes or water-insoluble pigments may be used) This step must be done into a clean pan deprived of any residues from the previous operations
5- Polishingbull After the coloring step the tablet surfaces tend to
be smooth but somewhat dull in appearance To achieve glossy finish final stage involving application of waxes (beeswax carnuba wax) is employed
6- Printingbull Different tablets could be identified by
manufacturer logo product name dosage strength or other appropriate code For sugar-coated tablets such identification could be only achieved by printing process using special edible inks
Brufenreg POMbull Available in 200mg and 400mg
strength
Premarinreg POMbull Conjugated oestrogens 625mcg
(maroon) and 125mcg (yellow)
Colofac reg Pbull Mebeverine hydrochloride
100mg Round white sugar coated
Kalms reg GSLbull 45mg Hops powder90mg
Gentian powdered extract and 135mg Valerian powdered extract
EXAMPLE OF SUGAR COATED TABLETS
SUGAR COATED PROCESS
bull Modern approach to coating tablets capsules or pellets bysurrounding them with a thin layer of polymeric material
bull Description of tablets Shape dictated by contour oforiginal core
bull Process Single stage process which involves spraying acoating solution containing the following
1 Polymer2 Solvent3 Plasticizer4 Colourant
The solution is sprayed onto a rotating tablet bed followedby drying which facilitates the removal of the solventleaving behind the deposition of thin film of coatingmaterials around each tablet
FILM COATING
AdvantagesProduce tablets in a single step process in
relatively short period of time Process enablesfunctional coatings to be incorporated into thedosage form
DisadvantagesThere are environmental and safety
implications of using organic solvent as well astheir financial expense
Types of film coating
A Immediate release
B Modified release
1Polymer
2PlasticizersPlasticizers are generally added to film coating formulations
to modify the physical properties of the polymer to make it
more usable One important property is their ability to
decrease film brittleness
Examples of plasticizers arepolyols such as polyethylene glycol 400
organic esters such as diethyl phthalate
oilsglycerides such as fractionated coconut oil
In general only water-miscible plasticizers can be used for aqueous-based
spray systems
31
3ColourantsAny permitted colourants in a film coat formula are invariably
water-insoluble colours (pigments) Pigments have certain
advantages over water-soluble colours they tend to be more
chemically stable towards light provide better opacity and
covering power and optimize the impermeability of a given film
to water vapour
Examples of colourants arebull iron oxide pigmentsbull titanium dioxidebull aluminum Lakes
32
4SolventsModern techniques now rely on water as a
polymer solvent because of the significant
drawbacks that readily became apparent with
the use of organic solvents
33
Nonentericmaterials eg
Hydroxypropyl methylcellulose (HPMC)Methylhydroxy ethyl cellulose (MHEC)Ethylcellulose (EC)Hydroxypropyl cellulose (HPC)Polyvinyl pyrrolidone (PVP)Sodium carboxymethyl cellulose (Sod CMC)Polyethylene glycols (PEG)Acrylate polymers eg Eudragit E
Enteric materials eg
Cellulose acetate phthalate (CAP)Acrylate polymers (Eudragit L S)Hydroxypropyl methylcellulose phthalate (HPMCP)Polyvinyl acetate phthalate (PVAP)
MATERIAL USED FOR FILM COATING
The vast majority of film coated tablets are produced by a process whichinvolves spraying of the coating material on to a bed of tablets AccelaCota is one example of equipment used for film coating
Accela Cota
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
Tablet coating is the application of coating composition to moving bed of tablets with concurrent use of heated air to facilitate evaporation of solvent
Basic principle of tablet coating
Type of tablet coating
bull Sugar coating
bull Film coating
bull Enteric coating
bull Controlled release coating
bull Specialized coating
Compressed coating
Electrostatic coating
Dip coating
Vacuum film coating
MANUFACTURE OF PHARMACEUTICAL TABLET COATING
EQUIPMENTS FOR TABLET COATING
Three general types of equipments are available
1Standard coating pan
eg Pellegrino pan systemImmersion sword systemImmersion tube system
2Perforated pan system
egAccela cota systemHicoater system
Glattcoater systemDriacoated system
3Fluidized bed coater
POLISHING
Standard Coating Pan
Immersion-tube system
Glatt Immersion
sword system
Pellegrini pan system
STANDARD COATING PAN
PERFORATED PANS
Accela cota system
Hi-coater system
PERFORATED PANS (continuehellip)
Dria coater pan
Glatt coater
FLUID BED COATING SYSTEMS
1 Film coating
2 Sugar coating
3 Press coating
Main coating processes
6 Printing5 Polishing4 Colouring3 Smoothing2 Sub coating1 Seal tablet core
bull Traditionally sugar coatings formed the bulk of coated tablets but today filmcoatings are the more modern technology in tablet coating
bull Description of tablets Smooth rounded and polished to a high glossbull Process Multistage Process involving 6 separate operations
Example of sugar coated tablets
Sugar coating
MULTISTAGE PROCESS
1 Sealing tablet core- application of a water impermeablepolymer such as Shellac cellulose acetate phthalate andpolyvinyl acetate phthalate which protects the core frommoisture increasing its shelf life
2 Sub coating -by adding bulking agents such as calciumcarbonate or talc in combination with sucrose solution
3 Smoothing process -remove rough layers formed in step2 with the application of sucrose syrup
4 Colouring - for aesthetic purposes often titanium basedpigments are included
5 Polishing - effectively polished to give characteristic shinecommonly using beeswax carnauba wax
6 Printing -indelible ink for characterisation
1- Sealing (Waterproofing)This involved the application of one or more coats of awaterproofing substance in the form of alcoholic spray such as pharmaceutical Shellac (traditionally) or syntheticpolymers such as CAP( Unless a modified-release feature needs to be introduced the amount of the sealing coat applied should be carefully calculated so that there is no negative effect on the drug release characteristics in case of immediate release product)
(WHY Sealing)a- Sugar-coatings are aqueous formulations which allowwater to penetrate directly into the tablet core and thuspotentially affecting product stability and possibly causingpremature tablet disintegrationb- Application of many coats of partially or completelywater-insoluble polymers in this step enables sugar-coatedproduct to exhibit modified-release pattern (extendedreleaseor delayed enteric- release characteristics)
2 Subcoatingbull - Large quantities of sugar-coatings are usually
applied to the tablet core (typically increasing the tablet weight by ( 50- 100)
WHY bull In order to round off the tablet edge Much of
this material build-up occurs during this stage and is achieved by adding a bulking agent such as Calcium carbonate to the sucrose solution
bull - Antiadherents eg Talc may be added after partial drying to prevent sticking of the tablets together
3- Smoothingbull The subcoating stage results in tablets with rough
surfaces To facilitate the color application (which requires smooth surface) subcoated tablets are smoothed out by a thick sucrose syrup coating
4- Coloringbull Color coatings usually consist of thin sucrose
syrup containing the requisite coloring materials (water-soluble dyes or water-insoluble pigments may be used) This step must be done into a clean pan deprived of any residues from the previous operations
5- Polishingbull After the coloring step the tablet surfaces tend to
be smooth but somewhat dull in appearance To achieve glossy finish final stage involving application of waxes (beeswax carnuba wax) is employed
6- Printingbull Different tablets could be identified by
manufacturer logo product name dosage strength or other appropriate code For sugar-coated tablets such identification could be only achieved by printing process using special edible inks
Brufenreg POMbull Available in 200mg and 400mg
strength
Premarinreg POMbull Conjugated oestrogens 625mcg
(maroon) and 125mcg (yellow)
Colofac reg Pbull Mebeverine hydrochloride
100mg Round white sugar coated
Kalms reg GSLbull 45mg Hops powder90mg
Gentian powdered extract and 135mg Valerian powdered extract
EXAMPLE OF SUGAR COATED TABLETS
SUGAR COATED PROCESS
bull Modern approach to coating tablets capsules or pellets bysurrounding them with a thin layer of polymeric material
bull Description of tablets Shape dictated by contour oforiginal core
bull Process Single stage process which involves spraying acoating solution containing the following
1 Polymer2 Solvent3 Plasticizer4 Colourant
The solution is sprayed onto a rotating tablet bed followedby drying which facilitates the removal of the solventleaving behind the deposition of thin film of coatingmaterials around each tablet
FILM COATING
AdvantagesProduce tablets in a single step process in
relatively short period of time Process enablesfunctional coatings to be incorporated into thedosage form
DisadvantagesThere are environmental and safety
implications of using organic solvent as well astheir financial expense
Types of film coating
A Immediate release
B Modified release
1Polymer
2PlasticizersPlasticizers are generally added to film coating formulations
to modify the physical properties of the polymer to make it
more usable One important property is their ability to
decrease film brittleness
Examples of plasticizers arepolyols such as polyethylene glycol 400
organic esters such as diethyl phthalate
oilsglycerides such as fractionated coconut oil
In general only water-miscible plasticizers can be used for aqueous-based
spray systems
31
3ColourantsAny permitted colourants in a film coat formula are invariably
water-insoluble colours (pigments) Pigments have certain
advantages over water-soluble colours they tend to be more
chemically stable towards light provide better opacity and
covering power and optimize the impermeability of a given film
to water vapour
Examples of colourants arebull iron oxide pigmentsbull titanium dioxidebull aluminum Lakes
32
4SolventsModern techniques now rely on water as a
polymer solvent because of the significant
drawbacks that readily became apparent with
the use of organic solvents
33
Nonentericmaterials eg
Hydroxypropyl methylcellulose (HPMC)Methylhydroxy ethyl cellulose (MHEC)Ethylcellulose (EC)Hydroxypropyl cellulose (HPC)Polyvinyl pyrrolidone (PVP)Sodium carboxymethyl cellulose (Sod CMC)Polyethylene glycols (PEG)Acrylate polymers eg Eudragit E
Enteric materials eg
Cellulose acetate phthalate (CAP)Acrylate polymers (Eudragit L S)Hydroxypropyl methylcellulose phthalate (HPMCP)Polyvinyl acetate phthalate (PVAP)
MATERIAL USED FOR FILM COATING
The vast majority of film coated tablets are produced by a process whichinvolves spraying of the coating material on to a bed of tablets AccelaCota is one example of equipment used for film coating
Accela Cota
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
Type of tablet coating
bull Sugar coating
bull Film coating
bull Enteric coating
bull Controlled release coating
bull Specialized coating
Compressed coating
Electrostatic coating
Dip coating
Vacuum film coating
MANUFACTURE OF PHARMACEUTICAL TABLET COATING
EQUIPMENTS FOR TABLET COATING
Three general types of equipments are available
1Standard coating pan
eg Pellegrino pan systemImmersion sword systemImmersion tube system
2Perforated pan system
egAccela cota systemHicoater system
Glattcoater systemDriacoated system
3Fluidized bed coater
POLISHING
Standard Coating Pan
Immersion-tube system
Glatt Immersion
sword system
Pellegrini pan system
STANDARD COATING PAN
PERFORATED PANS
Accela cota system
Hi-coater system
PERFORATED PANS (continuehellip)
Dria coater pan
Glatt coater
FLUID BED COATING SYSTEMS
1 Film coating
2 Sugar coating
3 Press coating
Main coating processes
6 Printing5 Polishing4 Colouring3 Smoothing2 Sub coating1 Seal tablet core
bull Traditionally sugar coatings formed the bulk of coated tablets but today filmcoatings are the more modern technology in tablet coating
bull Description of tablets Smooth rounded and polished to a high glossbull Process Multistage Process involving 6 separate operations
Example of sugar coated tablets
Sugar coating
MULTISTAGE PROCESS
1 Sealing tablet core- application of a water impermeablepolymer such as Shellac cellulose acetate phthalate andpolyvinyl acetate phthalate which protects the core frommoisture increasing its shelf life
2 Sub coating -by adding bulking agents such as calciumcarbonate or talc in combination with sucrose solution
3 Smoothing process -remove rough layers formed in step2 with the application of sucrose syrup
4 Colouring - for aesthetic purposes often titanium basedpigments are included
5 Polishing - effectively polished to give characteristic shinecommonly using beeswax carnauba wax
6 Printing -indelible ink for characterisation
1- Sealing (Waterproofing)This involved the application of one or more coats of awaterproofing substance in the form of alcoholic spray such as pharmaceutical Shellac (traditionally) or syntheticpolymers such as CAP( Unless a modified-release feature needs to be introduced the amount of the sealing coat applied should be carefully calculated so that there is no negative effect on the drug release characteristics in case of immediate release product)
(WHY Sealing)a- Sugar-coatings are aqueous formulations which allowwater to penetrate directly into the tablet core and thuspotentially affecting product stability and possibly causingpremature tablet disintegrationb- Application of many coats of partially or completelywater-insoluble polymers in this step enables sugar-coatedproduct to exhibit modified-release pattern (extendedreleaseor delayed enteric- release characteristics)
2 Subcoatingbull - Large quantities of sugar-coatings are usually
applied to the tablet core (typically increasing the tablet weight by ( 50- 100)
WHY bull In order to round off the tablet edge Much of
this material build-up occurs during this stage and is achieved by adding a bulking agent such as Calcium carbonate to the sucrose solution
bull - Antiadherents eg Talc may be added after partial drying to prevent sticking of the tablets together
3- Smoothingbull The subcoating stage results in tablets with rough
surfaces To facilitate the color application (which requires smooth surface) subcoated tablets are smoothed out by a thick sucrose syrup coating
4- Coloringbull Color coatings usually consist of thin sucrose
syrup containing the requisite coloring materials (water-soluble dyes or water-insoluble pigments may be used) This step must be done into a clean pan deprived of any residues from the previous operations
5- Polishingbull After the coloring step the tablet surfaces tend to
be smooth but somewhat dull in appearance To achieve glossy finish final stage involving application of waxes (beeswax carnuba wax) is employed
6- Printingbull Different tablets could be identified by
manufacturer logo product name dosage strength or other appropriate code For sugar-coated tablets such identification could be only achieved by printing process using special edible inks
Brufenreg POMbull Available in 200mg and 400mg
strength
Premarinreg POMbull Conjugated oestrogens 625mcg
(maroon) and 125mcg (yellow)
Colofac reg Pbull Mebeverine hydrochloride
100mg Round white sugar coated
Kalms reg GSLbull 45mg Hops powder90mg
Gentian powdered extract and 135mg Valerian powdered extract
EXAMPLE OF SUGAR COATED TABLETS
SUGAR COATED PROCESS
bull Modern approach to coating tablets capsules or pellets bysurrounding them with a thin layer of polymeric material
bull Description of tablets Shape dictated by contour oforiginal core
bull Process Single stage process which involves spraying acoating solution containing the following
1 Polymer2 Solvent3 Plasticizer4 Colourant
The solution is sprayed onto a rotating tablet bed followedby drying which facilitates the removal of the solventleaving behind the deposition of thin film of coatingmaterials around each tablet
FILM COATING
AdvantagesProduce tablets in a single step process in
relatively short period of time Process enablesfunctional coatings to be incorporated into thedosage form
DisadvantagesThere are environmental and safety
implications of using organic solvent as well astheir financial expense
Types of film coating
A Immediate release
B Modified release
1Polymer
2PlasticizersPlasticizers are generally added to film coating formulations
to modify the physical properties of the polymer to make it
more usable One important property is their ability to
decrease film brittleness
Examples of plasticizers arepolyols such as polyethylene glycol 400
organic esters such as diethyl phthalate
oilsglycerides such as fractionated coconut oil
In general only water-miscible plasticizers can be used for aqueous-based
spray systems
31
3ColourantsAny permitted colourants in a film coat formula are invariably
water-insoluble colours (pigments) Pigments have certain
advantages over water-soluble colours they tend to be more
chemically stable towards light provide better opacity and
covering power and optimize the impermeability of a given film
to water vapour
Examples of colourants arebull iron oxide pigmentsbull titanium dioxidebull aluminum Lakes
32
4SolventsModern techniques now rely on water as a
polymer solvent because of the significant
drawbacks that readily became apparent with
the use of organic solvents
33
Nonentericmaterials eg
Hydroxypropyl methylcellulose (HPMC)Methylhydroxy ethyl cellulose (MHEC)Ethylcellulose (EC)Hydroxypropyl cellulose (HPC)Polyvinyl pyrrolidone (PVP)Sodium carboxymethyl cellulose (Sod CMC)Polyethylene glycols (PEG)Acrylate polymers eg Eudragit E
Enteric materials eg
Cellulose acetate phthalate (CAP)Acrylate polymers (Eudragit L S)Hydroxypropyl methylcellulose phthalate (HPMCP)Polyvinyl acetate phthalate (PVAP)
MATERIAL USED FOR FILM COATING
The vast majority of film coated tablets are produced by a process whichinvolves spraying of the coating material on to a bed of tablets AccelaCota is one example of equipment used for film coating
Accela Cota
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
MANUFACTURE OF PHARMACEUTICAL TABLET COATING
EQUIPMENTS FOR TABLET COATING
Three general types of equipments are available
1Standard coating pan
eg Pellegrino pan systemImmersion sword systemImmersion tube system
2Perforated pan system
egAccela cota systemHicoater system
Glattcoater systemDriacoated system
3Fluidized bed coater
POLISHING
Standard Coating Pan
Immersion-tube system
Glatt Immersion
sword system
Pellegrini pan system
STANDARD COATING PAN
PERFORATED PANS
Accela cota system
Hi-coater system
PERFORATED PANS (continuehellip)
Dria coater pan
Glatt coater
FLUID BED COATING SYSTEMS
1 Film coating
2 Sugar coating
3 Press coating
Main coating processes
6 Printing5 Polishing4 Colouring3 Smoothing2 Sub coating1 Seal tablet core
bull Traditionally sugar coatings formed the bulk of coated tablets but today filmcoatings are the more modern technology in tablet coating
bull Description of tablets Smooth rounded and polished to a high glossbull Process Multistage Process involving 6 separate operations
Example of sugar coated tablets
Sugar coating
MULTISTAGE PROCESS
1 Sealing tablet core- application of a water impermeablepolymer such as Shellac cellulose acetate phthalate andpolyvinyl acetate phthalate which protects the core frommoisture increasing its shelf life
2 Sub coating -by adding bulking agents such as calciumcarbonate or talc in combination with sucrose solution
3 Smoothing process -remove rough layers formed in step2 with the application of sucrose syrup
4 Colouring - for aesthetic purposes often titanium basedpigments are included
5 Polishing - effectively polished to give characteristic shinecommonly using beeswax carnauba wax
6 Printing -indelible ink for characterisation
1- Sealing (Waterproofing)This involved the application of one or more coats of awaterproofing substance in the form of alcoholic spray such as pharmaceutical Shellac (traditionally) or syntheticpolymers such as CAP( Unless a modified-release feature needs to be introduced the amount of the sealing coat applied should be carefully calculated so that there is no negative effect on the drug release characteristics in case of immediate release product)
(WHY Sealing)a- Sugar-coatings are aqueous formulations which allowwater to penetrate directly into the tablet core and thuspotentially affecting product stability and possibly causingpremature tablet disintegrationb- Application of many coats of partially or completelywater-insoluble polymers in this step enables sugar-coatedproduct to exhibit modified-release pattern (extendedreleaseor delayed enteric- release characteristics)
2 Subcoatingbull - Large quantities of sugar-coatings are usually
applied to the tablet core (typically increasing the tablet weight by ( 50- 100)
WHY bull In order to round off the tablet edge Much of
this material build-up occurs during this stage and is achieved by adding a bulking agent such as Calcium carbonate to the sucrose solution
bull - Antiadherents eg Talc may be added after partial drying to prevent sticking of the tablets together
3- Smoothingbull The subcoating stage results in tablets with rough
surfaces To facilitate the color application (which requires smooth surface) subcoated tablets are smoothed out by a thick sucrose syrup coating
4- Coloringbull Color coatings usually consist of thin sucrose
syrup containing the requisite coloring materials (water-soluble dyes or water-insoluble pigments may be used) This step must be done into a clean pan deprived of any residues from the previous operations
5- Polishingbull After the coloring step the tablet surfaces tend to
be smooth but somewhat dull in appearance To achieve glossy finish final stage involving application of waxes (beeswax carnuba wax) is employed
6- Printingbull Different tablets could be identified by
manufacturer logo product name dosage strength or other appropriate code For sugar-coated tablets such identification could be only achieved by printing process using special edible inks
Brufenreg POMbull Available in 200mg and 400mg
strength
Premarinreg POMbull Conjugated oestrogens 625mcg
(maroon) and 125mcg (yellow)
Colofac reg Pbull Mebeverine hydrochloride
100mg Round white sugar coated
Kalms reg GSLbull 45mg Hops powder90mg
Gentian powdered extract and 135mg Valerian powdered extract
EXAMPLE OF SUGAR COATED TABLETS
SUGAR COATED PROCESS
bull Modern approach to coating tablets capsules or pellets bysurrounding them with a thin layer of polymeric material
bull Description of tablets Shape dictated by contour oforiginal core
bull Process Single stage process which involves spraying acoating solution containing the following
1 Polymer2 Solvent3 Plasticizer4 Colourant
The solution is sprayed onto a rotating tablet bed followedby drying which facilitates the removal of the solventleaving behind the deposition of thin film of coatingmaterials around each tablet
FILM COATING
AdvantagesProduce tablets in a single step process in
relatively short period of time Process enablesfunctional coatings to be incorporated into thedosage form
DisadvantagesThere are environmental and safety
implications of using organic solvent as well astheir financial expense
Types of film coating
A Immediate release
B Modified release
1Polymer
2PlasticizersPlasticizers are generally added to film coating formulations
to modify the physical properties of the polymer to make it
more usable One important property is their ability to
decrease film brittleness
Examples of plasticizers arepolyols such as polyethylene glycol 400
organic esters such as diethyl phthalate
oilsglycerides such as fractionated coconut oil
In general only water-miscible plasticizers can be used for aqueous-based
spray systems
31
3ColourantsAny permitted colourants in a film coat formula are invariably
water-insoluble colours (pigments) Pigments have certain
advantages over water-soluble colours they tend to be more
chemically stable towards light provide better opacity and
covering power and optimize the impermeability of a given film
to water vapour
Examples of colourants arebull iron oxide pigmentsbull titanium dioxidebull aluminum Lakes
32
4SolventsModern techniques now rely on water as a
polymer solvent because of the significant
drawbacks that readily became apparent with
the use of organic solvents
33
Nonentericmaterials eg
Hydroxypropyl methylcellulose (HPMC)Methylhydroxy ethyl cellulose (MHEC)Ethylcellulose (EC)Hydroxypropyl cellulose (HPC)Polyvinyl pyrrolidone (PVP)Sodium carboxymethyl cellulose (Sod CMC)Polyethylene glycols (PEG)Acrylate polymers eg Eudragit E
Enteric materials eg
Cellulose acetate phthalate (CAP)Acrylate polymers (Eudragit L S)Hydroxypropyl methylcellulose phthalate (HPMCP)Polyvinyl acetate phthalate (PVAP)
MATERIAL USED FOR FILM COATING
The vast majority of film coated tablets are produced by a process whichinvolves spraying of the coating material on to a bed of tablets AccelaCota is one example of equipment used for film coating
Accela Cota
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
EQUIPMENTS FOR TABLET COATING
Three general types of equipments are available
1Standard coating pan
eg Pellegrino pan systemImmersion sword systemImmersion tube system
2Perforated pan system
egAccela cota systemHicoater system
Glattcoater systemDriacoated system
3Fluidized bed coater
POLISHING
Standard Coating Pan
Immersion-tube system
Glatt Immersion
sword system
Pellegrini pan system
STANDARD COATING PAN
PERFORATED PANS
Accela cota system
Hi-coater system
PERFORATED PANS (continuehellip)
Dria coater pan
Glatt coater
FLUID BED COATING SYSTEMS
1 Film coating
2 Sugar coating
3 Press coating
Main coating processes
6 Printing5 Polishing4 Colouring3 Smoothing2 Sub coating1 Seal tablet core
bull Traditionally sugar coatings formed the bulk of coated tablets but today filmcoatings are the more modern technology in tablet coating
bull Description of tablets Smooth rounded and polished to a high glossbull Process Multistage Process involving 6 separate operations
Example of sugar coated tablets
Sugar coating
MULTISTAGE PROCESS
1 Sealing tablet core- application of a water impermeablepolymer such as Shellac cellulose acetate phthalate andpolyvinyl acetate phthalate which protects the core frommoisture increasing its shelf life
2 Sub coating -by adding bulking agents such as calciumcarbonate or talc in combination with sucrose solution
3 Smoothing process -remove rough layers formed in step2 with the application of sucrose syrup
4 Colouring - for aesthetic purposes often titanium basedpigments are included
5 Polishing - effectively polished to give characteristic shinecommonly using beeswax carnauba wax
6 Printing -indelible ink for characterisation
1- Sealing (Waterproofing)This involved the application of one or more coats of awaterproofing substance in the form of alcoholic spray such as pharmaceutical Shellac (traditionally) or syntheticpolymers such as CAP( Unless a modified-release feature needs to be introduced the amount of the sealing coat applied should be carefully calculated so that there is no negative effect on the drug release characteristics in case of immediate release product)
(WHY Sealing)a- Sugar-coatings are aqueous formulations which allowwater to penetrate directly into the tablet core and thuspotentially affecting product stability and possibly causingpremature tablet disintegrationb- Application of many coats of partially or completelywater-insoluble polymers in this step enables sugar-coatedproduct to exhibit modified-release pattern (extendedreleaseor delayed enteric- release characteristics)
2 Subcoatingbull - Large quantities of sugar-coatings are usually
applied to the tablet core (typically increasing the tablet weight by ( 50- 100)
WHY bull In order to round off the tablet edge Much of
this material build-up occurs during this stage and is achieved by adding a bulking agent such as Calcium carbonate to the sucrose solution
bull - Antiadherents eg Talc may be added after partial drying to prevent sticking of the tablets together
3- Smoothingbull The subcoating stage results in tablets with rough
surfaces To facilitate the color application (which requires smooth surface) subcoated tablets are smoothed out by a thick sucrose syrup coating
4- Coloringbull Color coatings usually consist of thin sucrose
syrup containing the requisite coloring materials (water-soluble dyes or water-insoluble pigments may be used) This step must be done into a clean pan deprived of any residues from the previous operations
5- Polishingbull After the coloring step the tablet surfaces tend to
be smooth but somewhat dull in appearance To achieve glossy finish final stage involving application of waxes (beeswax carnuba wax) is employed
6- Printingbull Different tablets could be identified by
manufacturer logo product name dosage strength or other appropriate code For sugar-coated tablets such identification could be only achieved by printing process using special edible inks
Brufenreg POMbull Available in 200mg and 400mg
strength
Premarinreg POMbull Conjugated oestrogens 625mcg
(maroon) and 125mcg (yellow)
Colofac reg Pbull Mebeverine hydrochloride
100mg Round white sugar coated
Kalms reg GSLbull 45mg Hops powder90mg
Gentian powdered extract and 135mg Valerian powdered extract
EXAMPLE OF SUGAR COATED TABLETS
SUGAR COATED PROCESS
bull Modern approach to coating tablets capsules or pellets bysurrounding them with a thin layer of polymeric material
bull Description of tablets Shape dictated by contour oforiginal core
bull Process Single stage process which involves spraying acoating solution containing the following
1 Polymer2 Solvent3 Plasticizer4 Colourant
The solution is sprayed onto a rotating tablet bed followedby drying which facilitates the removal of the solventleaving behind the deposition of thin film of coatingmaterials around each tablet
FILM COATING
AdvantagesProduce tablets in a single step process in
relatively short period of time Process enablesfunctional coatings to be incorporated into thedosage form
DisadvantagesThere are environmental and safety
implications of using organic solvent as well astheir financial expense
Types of film coating
A Immediate release
B Modified release
1Polymer
2PlasticizersPlasticizers are generally added to film coating formulations
to modify the physical properties of the polymer to make it
more usable One important property is their ability to
decrease film brittleness
Examples of plasticizers arepolyols such as polyethylene glycol 400
organic esters such as diethyl phthalate
oilsglycerides such as fractionated coconut oil
In general only water-miscible plasticizers can be used for aqueous-based
spray systems
31
3ColourantsAny permitted colourants in a film coat formula are invariably
water-insoluble colours (pigments) Pigments have certain
advantages over water-soluble colours they tend to be more
chemically stable towards light provide better opacity and
covering power and optimize the impermeability of a given film
to water vapour
Examples of colourants arebull iron oxide pigmentsbull titanium dioxidebull aluminum Lakes
32
4SolventsModern techniques now rely on water as a
polymer solvent because of the significant
drawbacks that readily became apparent with
the use of organic solvents
33
Nonentericmaterials eg
Hydroxypropyl methylcellulose (HPMC)Methylhydroxy ethyl cellulose (MHEC)Ethylcellulose (EC)Hydroxypropyl cellulose (HPC)Polyvinyl pyrrolidone (PVP)Sodium carboxymethyl cellulose (Sod CMC)Polyethylene glycols (PEG)Acrylate polymers eg Eudragit E
Enteric materials eg
Cellulose acetate phthalate (CAP)Acrylate polymers (Eudragit L S)Hydroxypropyl methylcellulose phthalate (HPMCP)Polyvinyl acetate phthalate (PVAP)
MATERIAL USED FOR FILM COATING
The vast majority of film coated tablets are produced by a process whichinvolves spraying of the coating material on to a bed of tablets AccelaCota is one example of equipment used for film coating
Accela Cota
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
POLISHING
Standard Coating Pan
Immersion-tube system
Glatt Immersion
sword system
Pellegrini pan system
STANDARD COATING PAN
PERFORATED PANS
Accela cota system
Hi-coater system
PERFORATED PANS (continuehellip)
Dria coater pan
Glatt coater
FLUID BED COATING SYSTEMS
1 Film coating
2 Sugar coating
3 Press coating
Main coating processes
6 Printing5 Polishing4 Colouring3 Smoothing2 Sub coating1 Seal tablet core
bull Traditionally sugar coatings formed the bulk of coated tablets but today filmcoatings are the more modern technology in tablet coating
bull Description of tablets Smooth rounded and polished to a high glossbull Process Multistage Process involving 6 separate operations
Example of sugar coated tablets
Sugar coating
MULTISTAGE PROCESS
1 Sealing tablet core- application of a water impermeablepolymer such as Shellac cellulose acetate phthalate andpolyvinyl acetate phthalate which protects the core frommoisture increasing its shelf life
2 Sub coating -by adding bulking agents such as calciumcarbonate or talc in combination with sucrose solution
3 Smoothing process -remove rough layers formed in step2 with the application of sucrose syrup
4 Colouring - for aesthetic purposes often titanium basedpigments are included
5 Polishing - effectively polished to give characteristic shinecommonly using beeswax carnauba wax
6 Printing -indelible ink for characterisation
1- Sealing (Waterproofing)This involved the application of one or more coats of awaterproofing substance in the form of alcoholic spray such as pharmaceutical Shellac (traditionally) or syntheticpolymers such as CAP( Unless a modified-release feature needs to be introduced the amount of the sealing coat applied should be carefully calculated so that there is no negative effect on the drug release characteristics in case of immediate release product)
(WHY Sealing)a- Sugar-coatings are aqueous formulations which allowwater to penetrate directly into the tablet core and thuspotentially affecting product stability and possibly causingpremature tablet disintegrationb- Application of many coats of partially or completelywater-insoluble polymers in this step enables sugar-coatedproduct to exhibit modified-release pattern (extendedreleaseor delayed enteric- release characteristics)
2 Subcoatingbull - Large quantities of sugar-coatings are usually
applied to the tablet core (typically increasing the tablet weight by ( 50- 100)
WHY bull In order to round off the tablet edge Much of
this material build-up occurs during this stage and is achieved by adding a bulking agent such as Calcium carbonate to the sucrose solution
bull - Antiadherents eg Talc may be added after partial drying to prevent sticking of the tablets together
3- Smoothingbull The subcoating stage results in tablets with rough
surfaces To facilitate the color application (which requires smooth surface) subcoated tablets are smoothed out by a thick sucrose syrup coating
4- Coloringbull Color coatings usually consist of thin sucrose
syrup containing the requisite coloring materials (water-soluble dyes or water-insoluble pigments may be used) This step must be done into a clean pan deprived of any residues from the previous operations
5- Polishingbull After the coloring step the tablet surfaces tend to
be smooth but somewhat dull in appearance To achieve glossy finish final stage involving application of waxes (beeswax carnuba wax) is employed
6- Printingbull Different tablets could be identified by
manufacturer logo product name dosage strength or other appropriate code For sugar-coated tablets such identification could be only achieved by printing process using special edible inks
Brufenreg POMbull Available in 200mg and 400mg
strength
Premarinreg POMbull Conjugated oestrogens 625mcg
(maroon) and 125mcg (yellow)
Colofac reg Pbull Mebeverine hydrochloride
100mg Round white sugar coated
Kalms reg GSLbull 45mg Hops powder90mg
Gentian powdered extract and 135mg Valerian powdered extract
EXAMPLE OF SUGAR COATED TABLETS
SUGAR COATED PROCESS
bull Modern approach to coating tablets capsules or pellets bysurrounding them with a thin layer of polymeric material
bull Description of tablets Shape dictated by contour oforiginal core
bull Process Single stage process which involves spraying acoating solution containing the following
1 Polymer2 Solvent3 Plasticizer4 Colourant
The solution is sprayed onto a rotating tablet bed followedby drying which facilitates the removal of the solventleaving behind the deposition of thin film of coatingmaterials around each tablet
FILM COATING
AdvantagesProduce tablets in a single step process in
relatively short period of time Process enablesfunctional coatings to be incorporated into thedosage form
DisadvantagesThere are environmental and safety
implications of using organic solvent as well astheir financial expense
Types of film coating
A Immediate release
B Modified release
1Polymer
2PlasticizersPlasticizers are generally added to film coating formulations
to modify the physical properties of the polymer to make it
more usable One important property is their ability to
decrease film brittleness
Examples of plasticizers arepolyols such as polyethylene glycol 400
organic esters such as diethyl phthalate
oilsglycerides such as fractionated coconut oil
In general only water-miscible plasticizers can be used for aqueous-based
spray systems
31
3ColourantsAny permitted colourants in a film coat formula are invariably
water-insoluble colours (pigments) Pigments have certain
advantages over water-soluble colours they tend to be more
chemically stable towards light provide better opacity and
covering power and optimize the impermeability of a given film
to water vapour
Examples of colourants arebull iron oxide pigmentsbull titanium dioxidebull aluminum Lakes
32
4SolventsModern techniques now rely on water as a
polymer solvent because of the significant
drawbacks that readily became apparent with
the use of organic solvents
33
Nonentericmaterials eg
Hydroxypropyl methylcellulose (HPMC)Methylhydroxy ethyl cellulose (MHEC)Ethylcellulose (EC)Hydroxypropyl cellulose (HPC)Polyvinyl pyrrolidone (PVP)Sodium carboxymethyl cellulose (Sod CMC)Polyethylene glycols (PEG)Acrylate polymers eg Eudragit E
Enteric materials eg
Cellulose acetate phthalate (CAP)Acrylate polymers (Eudragit L S)Hydroxypropyl methylcellulose phthalate (HPMCP)Polyvinyl acetate phthalate (PVAP)
MATERIAL USED FOR FILM COATING
The vast majority of film coated tablets are produced by a process whichinvolves spraying of the coating material on to a bed of tablets AccelaCota is one example of equipment used for film coating
Accela Cota
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
Standard Coating Pan
Immersion-tube system
Glatt Immersion
sword system
Pellegrini pan system
STANDARD COATING PAN
PERFORATED PANS
Accela cota system
Hi-coater system
PERFORATED PANS (continuehellip)
Dria coater pan
Glatt coater
FLUID BED COATING SYSTEMS
1 Film coating
2 Sugar coating
3 Press coating
Main coating processes
6 Printing5 Polishing4 Colouring3 Smoothing2 Sub coating1 Seal tablet core
bull Traditionally sugar coatings formed the bulk of coated tablets but today filmcoatings are the more modern technology in tablet coating
bull Description of tablets Smooth rounded and polished to a high glossbull Process Multistage Process involving 6 separate operations
Example of sugar coated tablets
Sugar coating
MULTISTAGE PROCESS
1 Sealing tablet core- application of a water impermeablepolymer such as Shellac cellulose acetate phthalate andpolyvinyl acetate phthalate which protects the core frommoisture increasing its shelf life
2 Sub coating -by adding bulking agents such as calciumcarbonate or talc in combination with sucrose solution
3 Smoothing process -remove rough layers formed in step2 with the application of sucrose syrup
4 Colouring - for aesthetic purposes often titanium basedpigments are included
5 Polishing - effectively polished to give characteristic shinecommonly using beeswax carnauba wax
6 Printing -indelible ink for characterisation
1- Sealing (Waterproofing)This involved the application of one or more coats of awaterproofing substance in the form of alcoholic spray such as pharmaceutical Shellac (traditionally) or syntheticpolymers such as CAP( Unless a modified-release feature needs to be introduced the amount of the sealing coat applied should be carefully calculated so that there is no negative effect on the drug release characteristics in case of immediate release product)
(WHY Sealing)a- Sugar-coatings are aqueous formulations which allowwater to penetrate directly into the tablet core and thuspotentially affecting product stability and possibly causingpremature tablet disintegrationb- Application of many coats of partially or completelywater-insoluble polymers in this step enables sugar-coatedproduct to exhibit modified-release pattern (extendedreleaseor delayed enteric- release characteristics)
2 Subcoatingbull - Large quantities of sugar-coatings are usually
applied to the tablet core (typically increasing the tablet weight by ( 50- 100)
WHY bull In order to round off the tablet edge Much of
this material build-up occurs during this stage and is achieved by adding a bulking agent such as Calcium carbonate to the sucrose solution
bull - Antiadherents eg Talc may be added after partial drying to prevent sticking of the tablets together
3- Smoothingbull The subcoating stage results in tablets with rough
surfaces To facilitate the color application (which requires smooth surface) subcoated tablets are smoothed out by a thick sucrose syrup coating
4- Coloringbull Color coatings usually consist of thin sucrose
syrup containing the requisite coloring materials (water-soluble dyes or water-insoluble pigments may be used) This step must be done into a clean pan deprived of any residues from the previous operations
5- Polishingbull After the coloring step the tablet surfaces tend to
be smooth but somewhat dull in appearance To achieve glossy finish final stage involving application of waxes (beeswax carnuba wax) is employed
6- Printingbull Different tablets could be identified by
manufacturer logo product name dosage strength or other appropriate code For sugar-coated tablets such identification could be only achieved by printing process using special edible inks
Brufenreg POMbull Available in 200mg and 400mg
strength
Premarinreg POMbull Conjugated oestrogens 625mcg
(maroon) and 125mcg (yellow)
Colofac reg Pbull Mebeverine hydrochloride
100mg Round white sugar coated
Kalms reg GSLbull 45mg Hops powder90mg
Gentian powdered extract and 135mg Valerian powdered extract
EXAMPLE OF SUGAR COATED TABLETS
SUGAR COATED PROCESS
bull Modern approach to coating tablets capsules or pellets bysurrounding them with a thin layer of polymeric material
bull Description of tablets Shape dictated by contour oforiginal core
bull Process Single stage process which involves spraying acoating solution containing the following
1 Polymer2 Solvent3 Plasticizer4 Colourant
The solution is sprayed onto a rotating tablet bed followedby drying which facilitates the removal of the solventleaving behind the deposition of thin film of coatingmaterials around each tablet
FILM COATING
AdvantagesProduce tablets in a single step process in
relatively short period of time Process enablesfunctional coatings to be incorporated into thedosage form
DisadvantagesThere are environmental and safety
implications of using organic solvent as well astheir financial expense
Types of film coating
A Immediate release
B Modified release
1Polymer
2PlasticizersPlasticizers are generally added to film coating formulations
to modify the physical properties of the polymer to make it
more usable One important property is their ability to
decrease film brittleness
Examples of plasticizers arepolyols such as polyethylene glycol 400
organic esters such as diethyl phthalate
oilsglycerides such as fractionated coconut oil
In general only water-miscible plasticizers can be used for aqueous-based
spray systems
31
3ColourantsAny permitted colourants in a film coat formula are invariably
water-insoluble colours (pigments) Pigments have certain
advantages over water-soluble colours they tend to be more
chemically stable towards light provide better opacity and
covering power and optimize the impermeability of a given film
to water vapour
Examples of colourants arebull iron oxide pigmentsbull titanium dioxidebull aluminum Lakes
32
4SolventsModern techniques now rely on water as a
polymer solvent because of the significant
drawbacks that readily became apparent with
the use of organic solvents
33
Nonentericmaterials eg
Hydroxypropyl methylcellulose (HPMC)Methylhydroxy ethyl cellulose (MHEC)Ethylcellulose (EC)Hydroxypropyl cellulose (HPC)Polyvinyl pyrrolidone (PVP)Sodium carboxymethyl cellulose (Sod CMC)Polyethylene glycols (PEG)Acrylate polymers eg Eudragit E
Enteric materials eg
Cellulose acetate phthalate (CAP)Acrylate polymers (Eudragit L S)Hydroxypropyl methylcellulose phthalate (HPMCP)Polyvinyl acetate phthalate (PVAP)
MATERIAL USED FOR FILM COATING
The vast majority of film coated tablets are produced by a process whichinvolves spraying of the coating material on to a bed of tablets AccelaCota is one example of equipment used for film coating
Accela Cota
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
PERFORATED PANS
Accela cota system
Hi-coater system
PERFORATED PANS (continuehellip)
Dria coater pan
Glatt coater
FLUID BED COATING SYSTEMS
1 Film coating
2 Sugar coating
3 Press coating
Main coating processes
6 Printing5 Polishing4 Colouring3 Smoothing2 Sub coating1 Seal tablet core
bull Traditionally sugar coatings formed the bulk of coated tablets but today filmcoatings are the more modern technology in tablet coating
bull Description of tablets Smooth rounded and polished to a high glossbull Process Multistage Process involving 6 separate operations
Example of sugar coated tablets
Sugar coating
MULTISTAGE PROCESS
1 Sealing tablet core- application of a water impermeablepolymer such as Shellac cellulose acetate phthalate andpolyvinyl acetate phthalate which protects the core frommoisture increasing its shelf life
2 Sub coating -by adding bulking agents such as calciumcarbonate or talc in combination with sucrose solution
3 Smoothing process -remove rough layers formed in step2 with the application of sucrose syrup
4 Colouring - for aesthetic purposes often titanium basedpigments are included
5 Polishing - effectively polished to give characteristic shinecommonly using beeswax carnauba wax
6 Printing -indelible ink for characterisation
1- Sealing (Waterproofing)This involved the application of one or more coats of awaterproofing substance in the form of alcoholic spray such as pharmaceutical Shellac (traditionally) or syntheticpolymers such as CAP( Unless a modified-release feature needs to be introduced the amount of the sealing coat applied should be carefully calculated so that there is no negative effect on the drug release characteristics in case of immediate release product)
(WHY Sealing)a- Sugar-coatings are aqueous formulations which allowwater to penetrate directly into the tablet core and thuspotentially affecting product stability and possibly causingpremature tablet disintegrationb- Application of many coats of partially or completelywater-insoluble polymers in this step enables sugar-coatedproduct to exhibit modified-release pattern (extendedreleaseor delayed enteric- release characteristics)
2 Subcoatingbull - Large quantities of sugar-coatings are usually
applied to the tablet core (typically increasing the tablet weight by ( 50- 100)
WHY bull In order to round off the tablet edge Much of
this material build-up occurs during this stage and is achieved by adding a bulking agent such as Calcium carbonate to the sucrose solution
bull - Antiadherents eg Talc may be added after partial drying to prevent sticking of the tablets together
3- Smoothingbull The subcoating stage results in tablets with rough
surfaces To facilitate the color application (which requires smooth surface) subcoated tablets are smoothed out by a thick sucrose syrup coating
4- Coloringbull Color coatings usually consist of thin sucrose
syrup containing the requisite coloring materials (water-soluble dyes or water-insoluble pigments may be used) This step must be done into a clean pan deprived of any residues from the previous operations
5- Polishingbull After the coloring step the tablet surfaces tend to
be smooth but somewhat dull in appearance To achieve glossy finish final stage involving application of waxes (beeswax carnuba wax) is employed
6- Printingbull Different tablets could be identified by
manufacturer logo product name dosage strength or other appropriate code For sugar-coated tablets such identification could be only achieved by printing process using special edible inks
Brufenreg POMbull Available in 200mg and 400mg
strength
Premarinreg POMbull Conjugated oestrogens 625mcg
(maroon) and 125mcg (yellow)
Colofac reg Pbull Mebeverine hydrochloride
100mg Round white sugar coated
Kalms reg GSLbull 45mg Hops powder90mg
Gentian powdered extract and 135mg Valerian powdered extract
EXAMPLE OF SUGAR COATED TABLETS
SUGAR COATED PROCESS
bull Modern approach to coating tablets capsules or pellets bysurrounding them with a thin layer of polymeric material
bull Description of tablets Shape dictated by contour oforiginal core
bull Process Single stage process which involves spraying acoating solution containing the following
1 Polymer2 Solvent3 Plasticizer4 Colourant
The solution is sprayed onto a rotating tablet bed followedby drying which facilitates the removal of the solventleaving behind the deposition of thin film of coatingmaterials around each tablet
FILM COATING
AdvantagesProduce tablets in a single step process in
relatively short period of time Process enablesfunctional coatings to be incorporated into thedosage form
DisadvantagesThere are environmental and safety
implications of using organic solvent as well astheir financial expense
Types of film coating
A Immediate release
B Modified release
1Polymer
2PlasticizersPlasticizers are generally added to film coating formulations
to modify the physical properties of the polymer to make it
more usable One important property is their ability to
decrease film brittleness
Examples of plasticizers arepolyols such as polyethylene glycol 400
organic esters such as diethyl phthalate
oilsglycerides such as fractionated coconut oil
In general only water-miscible plasticizers can be used for aqueous-based
spray systems
31
3ColourantsAny permitted colourants in a film coat formula are invariably
water-insoluble colours (pigments) Pigments have certain
advantages over water-soluble colours they tend to be more
chemically stable towards light provide better opacity and
covering power and optimize the impermeability of a given film
to water vapour
Examples of colourants arebull iron oxide pigmentsbull titanium dioxidebull aluminum Lakes
32
4SolventsModern techniques now rely on water as a
polymer solvent because of the significant
drawbacks that readily became apparent with
the use of organic solvents
33
Nonentericmaterials eg
Hydroxypropyl methylcellulose (HPMC)Methylhydroxy ethyl cellulose (MHEC)Ethylcellulose (EC)Hydroxypropyl cellulose (HPC)Polyvinyl pyrrolidone (PVP)Sodium carboxymethyl cellulose (Sod CMC)Polyethylene glycols (PEG)Acrylate polymers eg Eudragit E
Enteric materials eg
Cellulose acetate phthalate (CAP)Acrylate polymers (Eudragit L S)Hydroxypropyl methylcellulose phthalate (HPMCP)Polyvinyl acetate phthalate (PVAP)
MATERIAL USED FOR FILM COATING
The vast majority of film coated tablets are produced by a process whichinvolves spraying of the coating material on to a bed of tablets AccelaCota is one example of equipment used for film coating
Accela Cota
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
PERFORATED PANS (continuehellip)
Dria coater pan
Glatt coater
FLUID BED COATING SYSTEMS
1 Film coating
2 Sugar coating
3 Press coating
Main coating processes
6 Printing5 Polishing4 Colouring3 Smoothing2 Sub coating1 Seal tablet core
bull Traditionally sugar coatings formed the bulk of coated tablets but today filmcoatings are the more modern technology in tablet coating
bull Description of tablets Smooth rounded and polished to a high glossbull Process Multistage Process involving 6 separate operations
Example of sugar coated tablets
Sugar coating
MULTISTAGE PROCESS
1 Sealing tablet core- application of a water impermeablepolymer such as Shellac cellulose acetate phthalate andpolyvinyl acetate phthalate which protects the core frommoisture increasing its shelf life
2 Sub coating -by adding bulking agents such as calciumcarbonate or talc in combination with sucrose solution
3 Smoothing process -remove rough layers formed in step2 with the application of sucrose syrup
4 Colouring - for aesthetic purposes often titanium basedpigments are included
5 Polishing - effectively polished to give characteristic shinecommonly using beeswax carnauba wax
6 Printing -indelible ink for characterisation
1- Sealing (Waterproofing)This involved the application of one or more coats of awaterproofing substance in the form of alcoholic spray such as pharmaceutical Shellac (traditionally) or syntheticpolymers such as CAP( Unless a modified-release feature needs to be introduced the amount of the sealing coat applied should be carefully calculated so that there is no negative effect on the drug release characteristics in case of immediate release product)
(WHY Sealing)a- Sugar-coatings are aqueous formulations which allowwater to penetrate directly into the tablet core and thuspotentially affecting product stability and possibly causingpremature tablet disintegrationb- Application of many coats of partially or completelywater-insoluble polymers in this step enables sugar-coatedproduct to exhibit modified-release pattern (extendedreleaseor delayed enteric- release characteristics)
2 Subcoatingbull - Large quantities of sugar-coatings are usually
applied to the tablet core (typically increasing the tablet weight by ( 50- 100)
WHY bull In order to round off the tablet edge Much of
this material build-up occurs during this stage and is achieved by adding a bulking agent such as Calcium carbonate to the sucrose solution
bull - Antiadherents eg Talc may be added after partial drying to prevent sticking of the tablets together
3- Smoothingbull The subcoating stage results in tablets with rough
surfaces To facilitate the color application (which requires smooth surface) subcoated tablets are smoothed out by a thick sucrose syrup coating
4- Coloringbull Color coatings usually consist of thin sucrose
syrup containing the requisite coloring materials (water-soluble dyes or water-insoluble pigments may be used) This step must be done into a clean pan deprived of any residues from the previous operations
5- Polishingbull After the coloring step the tablet surfaces tend to
be smooth but somewhat dull in appearance To achieve glossy finish final stage involving application of waxes (beeswax carnuba wax) is employed
6- Printingbull Different tablets could be identified by
manufacturer logo product name dosage strength or other appropriate code For sugar-coated tablets such identification could be only achieved by printing process using special edible inks
Brufenreg POMbull Available in 200mg and 400mg
strength
Premarinreg POMbull Conjugated oestrogens 625mcg
(maroon) and 125mcg (yellow)
Colofac reg Pbull Mebeverine hydrochloride
100mg Round white sugar coated
Kalms reg GSLbull 45mg Hops powder90mg
Gentian powdered extract and 135mg Valerian powdered extract
EXAMPLE OF SUGAR COATED TABLETS
SUGAR COATED PROCESS
bull Modern approach to coating tablets capsules or pellets bysurrounding them with a thin layer of polymeric material
bull Description of tablets Shape dictated by contour oforiginal core
bull Process Single stage process which involves spraying acoating solution containing the following
1 Polymer2 Solvent3 Plasticizer4 Colourant
The solution is sprayed onto a rotating tablet bed followedby drying which facilitates the removal of the solventleaving behind the deposition of thin film of coatingmaterials around each tablet
FILM COATING
AdvantagesProduce tablets in a single step process in
relatively short period of time Process enablesfunctional coatings to be incorporated into thedosage form
DisadvantagesThere are environmental and safety
implications of using organic solvent as well astheir financial expense
Types of film coating
A Immediate release
B Modified release
1Polymer
2PlasticizersPlasticizers are generally added to film coating formulations
to modify the physical properties of the polymer to make it
more usable One important property is their ability to
decrease film brittleness
Examples of plasticizers arepolyols such as polyethylene glycol 400
organic esters such as diethyl phthalate
oilsglycerides such as fractionated coconut oil
In general only water-miscible plasticizers can be used for aqueous-based
spray systems
31
3ColourantsAny permitted colourants in a film coat formula are invariably
water-insoluble colours (pigments) Pigments have certain
advantages over water-soluble colours they tend to be more
chemically stable towards light provide better opacity and
covering power and optimize the impermeability of a given film
to water vapour
Examples of colourants arebull iron oxide pigmentsbull titanium dioxidebull aluminum Lakes
32
4SolventsModern techniques now rely on water as a
polymer solvent because of the significant
drawbacks that readily became apparent with
the use of organic solvents
33
Nonentericmaterials eg
Hydroxypropyl methylcellulose (HPMC)Methylhydroxy ethyl cellulose (MHEC)Ethylcellulose (EC)Hydroxypropyl cellulose (HPC)Polyvinyl pyrrolidone (PVP)Sodium carboxymethyl cellulose (Sod CMC)Polyethylene glycols (PEG)Acrylate polymers eg Eudragit E
Enteric materials eg
Cellulose acetate phthalate (CAP)Acrylate polymers (Eudragit L S)Hydroxypropyl methylcellulose phthalate (HPMCP)Polyvinyl acetate phthalate (PVAP)
MATERIAL USED FOR FILM COATING
The vast majority of film coated tablets are produced by a process whichinvolves spraying of the coating material on to a bed of tablets AccelaCota is one example of equipment used for film coating
Accela Cota
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
FLUID BED COATING SYSTEMS
1 Film coating
2 Sugar coating
3 Press coating
Main coating processes
6 Printing5 Polishing4 Colouring3 Smoothing2 Sub coating1 Seal tablet core
bull Traditionally sugar coatings formed the bulk of coated tablets but today filmcoatings are the more modern technology in tablet coating
bull Description of tablets Smooth rounded and polished to a high glossbull Process Multistage Process involving 6 separate operations
Example of sugar coated tablets
Sugar coating
MULTISTAGE PROCESS
1 Sealing tablet core- application of a water impermeablepolymer such as Shellac cellulose acetate phthalate andpolyvinyl acetate phthalate which protects the core frommoisture increasing its shelf life
2 Sub coating -by adding bulking agents such as calciumcarbonate or talc in combination with sucrose solution
3 Smoothing process -remove rough layers formed in step2 with the application of sucrose syrup
4 Colouring - for aesthetic purposes often titanium basedpigments are included
5 Polishing - effectively polished to give characteristic shinecommonly using beeswax carnauba wax
6 Printing -indelible ink for characterisation
1- Sealing (Waterproofing)This involved the application of one or more coats of awaterproofing substance in the form of alcoholic spray such as pharmaceutical Shellac (traditionally) or syntheticpolymers such as CAP( Unless a modified-release feature needs to be introduced the amount of the sealing coat applied should be carefully calculated so that there is no negative effect on the drug release characteristics in case of immediate release product)
(WHY Sealing)a- Sugar-coatings are aqueous formulations which allowwater to penetrate directly into the tablet core and thuspotentially affecting product stability and possibly causingpremature tablet disintegrationb- Application of many coats of partially or completelywater-insoluble polymers in this step enables sugar-coatedproduct to exhibit modified-release pattern (extendedreleaseor delayed enteric- release characteristics)
2 Subcoatingbull - Large quantities of sugar-coatings are usually
applied to the tablet core (typically increasing the tablet weight by ( 50- 100)
WHY bull In order to round off the tablet edge Much of
this material build-up occurs during this stage and is achieved by adding a bulking agent such as Calcium carbonate to the sucrose solution
bull - Antiadherents eg Talc may be added after partial drying to prevent sticking of the tablets together
3- Smoothingbull The subcoating stage results in tablets with rough
surfaces To facilitate the color application (which requires smooth surface) subcoated tablets are smoothed out by a thick sucrose syrup coating
4- Coloringbull Color coatings usually consist of thin sucrose
syrup containing the requisite coloring materials (water-soluble dyes or water-insoluble pigments may be used) This step must be done into a clean pan deprived of any residues from the previous operations
5- Polishingbull After the coloring step the tablet surfaces tend to
be smooth but somewhat dull in appearance To achieve glossy finish final stage involving application of waxes (beeswax carnuba wax) is employed
6- Printingbull Different tablets could be identified by
manufacturer logo product name dosage strength or other appropriate code For sugar-coated tablets such identification could be only achieved by printing process using special edible inks
Brufenreg POMbull Available in 200mg and 400mg
strength
Premarinreg POMbull Conjugated oestrogens 625mcg
(maroon) and 125mcg (yellow)
Colofac reg Pbull Mebeverine hydrochloride
100mg Round white sugar coated
Kalms reg GSLbull 45mg Hops powder90mg
Gentian powdered extract and 135mg Valerian powdered extract
EXAMPLE OF SUGAR COATED TABLETS
SUGAR COATED PROCESS
bull Modern approach to coating tablets capsules or pellets bysurrounding them with a thin layer of polymeric material
bull Description of tablets Shape dictated by contour oforiginal core
bull Process Single stage process which involves spraying acoating solution containing the following
1 Polymer2 Solvent3 Plasticizer4 Colourant
The solution is sprayed onto a rotating tablet bed followedby drying which facilitates the removal of the solventleaving behind the deposition of thin film of coatingmaterials around each tablet
FILM COATING
AdvantagesProduce tablets in a single step process in
relatively short period of time Process enablesfunctional coatings to be incorporated into thedosage form
DisadvantagesThere are environmental and safety
implications of using organic solvent as well astheir financial expense
Types of film coating
A Immediate release
B Modified release
1Polymer
2PlasticizersPlasticizers are generally added to film coating formulations
to modify the physical properties of the polymer to make it
more usable One important property is their ability to
decrease film brittleness
Examples of plasticizers arepolyols such as polyethylene glycol 400
organic esters such as diethyl phthalate
oilsglycerides such as fractionated coconut oil
In general only water-miscible plasticizers can be used for aqueous-based
spray systems
31
3ColourantsAny permitted colourants in a film coat formula are invariably
water-insoluble colours (pigments) Pigments have certain
advantages over water-soluble colours they tend to be more
chemically stable towards light provide better opacity and
covering power and optimize the impermeability of a given film
to water vapour
Examples of colourants arebull iron oxide pigmentsbull titanium dioxidebull aluminum Lakes
32
4SolventsModern techniques now rely on water as a
polymer solvent because of the significant
drawbacks that readily became apparent with
the use of organic solvents
33
Nonentericmaterials eg
Hydroxypropyl methylcellulose (HPMC)Methylhydroxy ethyl cellulose (MHEC)Ethylcellulose (EC)Hydroxypropyl cellulose (HPC)Polyvinyl pyrrolidone (PVP)Sodium carboxymethyl cellulose (Sod CMC)Polyethylene glycols (PEG)Acrylate polymers eg Eudragit E
Enteric materials eg
Cellulose acetate phthalate (CAP)Acrylate polymers (Eudragit L S)Hydroxypropyl methylcellulose phthalate (HPMCP)Polyvinyl acetate phthalate (PVAP)
MATERIAL USED FOR FILM COATING
The vast majority of film coated tablets are produced by a process whichinvolves spraying of the coating material on to a bed of tablets AccelaCota is one example of equipment used for film coating
Accela Cota
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
1 Film coating
2 Sugar coating
3 Press coating
Main coating processes
6 Printing5 Polishing4 Colouring3 Smoothing2 Sub coating1 Seal tablet core
bull Traditionally sugar coatings formed the bulk of coated tablets but today filmcoatings are the more modern technology in tablet coating
bull Description of tablets Smooth rounded and polished to a high glossbull Process Multistage Process involving 6 separate operations
Example of sugar coated tablets
Sugar coating
MULTISTAGE PROCESS
1 Sealing tablet core- application of a water impermeablepolymer such as Shellac cellulose acetate phthalate andpolyvinyl acetate phthalate which protects the core frommoisture increasing its shelf life
2 Sub coating -by adding bulking agents such as calciumcarbonate or talc in combination with sucrose solution
3 Smoothing process -remove rough layers formed in step2 with the application of sucrose syrup
4 Colouring - for aesthetic purposes often titanium basedpigments are included
5 Polishing - effectively polished to give characteristic shinecommonly using beeswax carnauba wax
6 Printing -indelible ink for characterisation
1- Sealing (Waterproofing)This involved the application of one or more coats of awaterproofing substance in the form of alcoholic spray such as pharmaceutical Shellac (traditionally) or syntheticpolymers such as CAP( Unless a modified-release feature needs to be introduced the amount of the sealing coat applied should be carefully calculated so that there is no negative effect on the drug release characteristics in case of immediate release product)
(WHY Sealing)a- Sugar-coatings are aqueous formulations which allowwater to penetrate directly into the tablet core and thuspotentially affecting product stability and possibly causingpremature tablet disintegrationb- Application of many coats of partially or completelywater-insoluble polymers in this step enables sugar-coatedproduct to exhibit modified-release pattern (extendedreleaseor delayed enteric- release characteristics)
2 Subcoatingbull - Large quantities of sugar-coatings are usually
applied to the tablet core (typically increasing the tablet weight by ( 50- 100)
WHY bull In order to round off the tablet edge Much of
this material build-up occurs during this stage and is achieved by adding a bulking agent such as Calcium carbonate to the sucrose solution
bull - Antiadherents eg Talc may be added after partial drying to prevent sticking of the tablets together
3- Smoothingbull The subcoating stage results in tablets with rough
surfaces To facilitate the color application (which requires smooth surface) subcoated tablets are smoothed out by a thick sucrose syrup coating
4- Coloringbull Color coatings usually consist of thin sucrose
syrup containing the requisite coloring materials (water-soluble dyes or water-insoluble pigments may be used) This step must be done into a clean pan deprived of any residues from the previous operations
5- Polishingbull After the coloring step the tablet surfaces tend to
be smooth but somewhat dull in appearance To achieve glossy finish final stage involving application of waxes (beeswax carnuba wax) is employed
6- Printingbull Different tablets could be identified by
manufacturer logo product name dosage strength or other appropriate code For sugar-coated tablets such identification could be only achieved by printing process using special edible inks
Brufenreg POMbull Available in 200mg and 400mg
strength
Premarinreg POMbull Conjugated oestrogens 625mcg
(maroon) and 125mcg (yellow)
Colofac reg Pbull Mebeverine hydrochloride
100mg Round white sugar coated
Kalms reg GSLbull 45mg Hops powder90mg
Gentian powdered extract and 135mg Valerian powdered extract
EXAMPLE OF SUGAR COATED TABLETS
SUGAR COATED PROCESS
bull Modern approach to coating tablets capsules or pellets bysurrounding them with a thin layer of polymeric material
bull Description of tablets Shape dictated by contour oforiginal core
bull Process Single stage process which involves spraying acoating solution containing the following
1 Polymer2 Solvent3 Plasticizer4 Colourant
The solution is sprayed onto a rotating tablet bed followedby drying which facilitates the removal of the solventleaving behind the deposition of thin film of coatingmaterials around each tablet
FILM COATING
AdvantagesProduce tablets in a single step process in
relatively short period of time Process enablesfunctional coatings to be incorporated into thedosage form
DisadvantagesThere are environmental and safety
implications of using organic solvent as well astheir financial expense
Types of film coating
A Immediate release
B Modified release
1Polymer
2PlasticizersPlasticizers are generally added to film coating formulations
to modify the physical properties of the polymer to make it
more usable One important property is their ability to
decrease film brittleness
Examples of plasticizers arepolyols such as polyethylene glycol 400
organic esters such as diethyl phthalate
oilsglycerides such as fractionated coconut oil
In general only water-miscible plasticizers can be used for aqueous-based
spray systems
31
3ColourantsAny permitted colourants in a film coat formula are invariably
water-insoluble colours (pigments) Pigments have certain
advantages over water-soluble colours they tend to be more
chemically stable towards light provide better opacity and
covering power and optimize the impermeability of a given film
to water vapour
Examples of colourants arebull iron oxide pigmentsbull titanium dioxidebull aluminum Lakes
32
4SolventsModern techniques now rely on water as a
polymer solvent because of the significant
drawbacks that readily became apparent with
the use of organic solvents
33
Nonentericmaterials eg
Hydroxypropyl methylcellulose (HPMC)Methylhydroxy ethyl cellulose (MHEC)Ethylcellulose (EC)Hydroxypropyl cellulose (HPC)Polyvinyl pyrrolidone (PVP)Sodium carboxymethyl cellulose (Sod CMC)Polyethylene glycols (PEG)Acrylate polymers eg Eudragit E
Enteric materials eg
Cellulose acetate phthalate (CAP)Acrylate polymers (Eudragit L S)Hydroxypropyl methylcellulose phthalate (HPMCP)Polyvinyl acetate phthalate (PVAP)
MATERIAL USED FOR FILM COATING
The vast majority of film coated tablets are produced by a process whichinvolves spraying of the coating material on to a bed of tablets AccelaCota is one example of equipment used for film coating
Accela Cota
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
6 Printing5 Polishing4 Colouring3 Smoothing2 Sub coating1 Seal tablet core
bull Traditionally sugar coatings formed the bulk of coated tablets but today filmcoatings are the more modern technology in tablet coating
bull Description of tablets Smooth rounded and polished to a high glossbull Process Multistage Process involving 6 separate operations
Example of sugar coated tablets
Sugar coating
MULTISTAGE PROCESS
1 Sealing tablet core- application of a water impermeablepolymer such as Shellac cellulose acetate phthalate andpolyvinyl acetate phthalate which protects the core frommoisture increasing its shelf life
2 Sub coating -by adding bulking agents such as calciumcarbonate or talc in combination with sucrose solution
3 Smoothing process -remove rough layers formed in step2 with the application of sucrose syrup
4 Colouring - for aesthetic purposes often titanium basedpigments are included
5 Polishing - effectively polished to give characteristic shinecommonly using beeswax carnauba wax
6 Printing -indelible ink for characterisation
1- Sealing (Waterproofing)This involved the application of one or more coats of awaterproofing substance in the form of alcoholic spray such as pharmaceutical Shellac (traditionally) or syntheticpolymers such as CAP( Unless a modified-release feature needs to be introduced the amount of the sealing coat applied should be carefully calculated so that there is no negative effect on the drug release characteristics in case of immediate release product)
(WHY Sealing)a- Sugar-coatings are aqueous formulations which allowwater to penetrate directly into the tablet core and thuspotentially affecting product stability and possibly causingpremature tablet disintegrationb- Application of many coats of partially or completelywater-insoluble polymers in this step enables sugar-coatedproduct to exhibit modified-release pattern (extendedreleaseor delayed enteric- release characteristics)
2 Subcoatingbull - Large quantities of sugar-coatings are usually
applied to the tablet core (typically increasing the tablet weight by ( 50- 100)
WHY bull In order to round off the tablet edge Much of
this material build-up occurs during this stage and is achieved by adding a bulking agent such as Calcium carbonate to the sucrose solution
bull - Antiadherents eg Talc may be added after partial drying to prevent sticking of the tablets together
3- Smoothingbull The subcoating stage results in tablets with rough
surfaces To facilitate the color application (which requires smooth surface) subcoated tablets are smoothed out by a thick sucrose syrup coating
4- Coloringbull Color coatings usually consist of thin sucrose
syrup containing the requisite coloring materials (water-soluble dyes or water-insoluble pigments may be used) This step must be done into a clean pan deprived of any residues from the previous operations
5- Polishingbull After the coloring step the tablet surfaces tend to
be smooth but somewhat dull in appearance To achieve glossy finish final stage involving application of waxes (beeswax carnuba wax) is employed
6- Printingbull Different tablets could be identified by
manufacturer logo product name dosage strength or other appropriate code For sugar-coated tablets such identification could be only achieved by printing process using special edible inks
Brufenreg POMbull Available in 200mg and 400mg
strength
Premarinreg POMbull Conjugated oestrogens 625mcg
(maroon) and 125mcg (yellow)
Colofac reg Pbull Mebeverine hydrochloride
100mg Round white sugar coated
Kalms reg GSLbull 45mg Hops powder90mg
Gentian powdered extract and 135mg Valerian powdered extract
EXAMPLE OF SUGAR COATED TABLETS
SUGAR COATED PROCESS
bull Modern approach to coating tablets capsules or pellets bysurrounding them with a thin layer of polymeric material
bull Description of tablets Shape dictated by contour oforiginal core
bull Process Single stage process which involves spraying acoating solution containing the following
1 Polymer2 Solvent3 Plasticizer4 Colourant
The solution is sprayed onto a rotating tablet bed followedby drying which facilitates the removal of the solventleaving behind the deposition of thin film of coatingmaterials around each tablet
FILM COATING
AdvantagesProduce tablets in a single step process in
relatively short period of time Process enablesfunctional coatings to be incorporated into thedosage form
DisadvantagesThere are environmental and safety
implications of using organic solvent as well astheir financial expense
Types of film coating
A Immediate release
B Modified release
1Polymer
2PlasticizersPlasticizers are generally added to film coating formulations
to modify the physical properties of the polymer to make it
more usable One important property is their ability to
decrease film brittleness
Examples of plasticizers arepolyols such as polyethylene glycol 400
organic esters such as diethyl phthalate
oilsglycerides such as fractionated coconut oil
In general only water-miscible plasticizers can be used for aqueous-based
spray systems
31
3ColourantsAny permitted colourants in a film coat formula are invariably
water-insoluble colours (pigments) Pigments have certain
advantages over water-soluble colours they tend to be more
chemically stable towards light provide better opacity and
covering power and optimize the impermeability of a given film
to water vapour
Examples of colourants arebull iron oxide pigmentsbull titanium dioxidebull aluminum Lakes
32
4SolventsModern techniques now rely on water as a
polymer solvent because of the significant
drawbacks that readily became apparent with
the use of organic solvents
33
Nonentericmaterials eg
Hydroxypropyl methylcellulose (HPMC)Methylhydroxy ethyl cellulose (MHEC)Ethylcellulose (EC)Hydroxypropyl cellulose (HPC)Polyvinyl pyrrolidone (PVP)Sodium carboxymethyl cellulose (Sod CMC)Polyethylene glycols (PEG)Acrylate polymers eg Eudragit E
Enteric materials eg
Cellulose acetate phthalate (CAP)Acrylate polymers (Eudragit L S)Hydroxypropyl methylcellulose phthalate (HPMCP)Polyvinyl acetate phthalate (PVAP)
MATERIAL USED FOR FILM COATING
The vast majority of film coated tablets are produced by a process whichinvolves spraying of the coating material on to a bed of tablets AccelaCota is one example of equipment used for film coating
Accela Cota
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
MULTISTAGE PROCESS
1 Sealing tablet core- application of a water impermeablepolymer such as Shellac cellulose acetate phthalate andpolyvinyl acetate phthalate which protects the core frommoisture increasing its shelf life
2 Sub coating -by adding bulking agents such as calciumcarbonate or talc in combination with sucrose solution
3 Smoothing process -remove rough layers formed in step2 with the application of sucrose syrup
4 Colouring - for aesthetic purposes often titanium basedpigments are included
5 Polishing - effectively polished to give characteristic shinecommonly using beeswax carnauba wax
6 Printing -indelible ink for characterisation
1- Sealing (Waterproofing)This involved the application of one or more coats of awaterproofing substance in the form of alcoholic spray such as pharmaceutical Shellac (traditionally) or syntheticpolymers such as CAP( Unless a modified-release feature needs to be introduced the amount of the sealing coat applied should be carefully calculated so that there is no negative effect on the drug release characteristics in case of immediate release product)
(WHY Sealing)a- Sugar-coatings are aqueous formulations which allowwater to penetrate directly into the tablet core and thuspotentially affecting product stability and possibly causingpremature tablet disintegrationb- Application of many coats of partially or completelywater-insoluble polymers in this step enables sugar-coatedproduct to exhibit modified-release pattern (extendedreleaseor delayed enteric- release characteristics)
2 Subcoatingbull - Large quantities of sugar-coatings are usually
applied to the tablet core (typically increasing the tablet weight by ( 50- 100)
WHY bull In order to round off the tablet edge Much of
this material build-up occurs during this stage and is achieved by adding a bulking agent such as Calcium carbonate to the sucrose solution
bull - Antiadherents eg Talc may be added after partial drying to prevent sticking of the tablets together
3- Smoothingbull The subcoating stage results in tablets with rough
surfaces To facilitate the color application (which requires smooth surface) subcoated tablets are smoothed out by a thick sucrose syrup coating
4- Coloringbull Color coatings usually consist of thin sucrose
syrup containing the requisite coloring materials (water-soluble dyes or water-insoluble pigments may be used) This step must be done into a clean pan deprived of any residues from the previous operations
5- Polishingbull After the coloring step the tablet surfaces tend to
be smooth but somewhat dull in appearance To achieve glossy finish final stage involving application of waxes (beeswax carnuba wax) is employed
6- Printingbull Different tablets could be identified by
manufacturer logo product name dosage strength or other appropriate code For sugar-coated tablets such identification could be only achieved by printing process using special edible inks
Brufenreg POMbull Available in 200mg and 400mg
strength
Premarinreg POMbull Conjugated oestrogens 625mcg
(maroon) and 125mcg (yellow)
Colofac reg Pbull Mebeverine hydrochloride
100mg Round white sugar coated
Kalms reg GSLbull 45mg Hops powder90mg
Gentian powdered extract and 135mg Valerian powdered extract
EXAMPLE OF SUGAR COATED TABLETS
SUGAR COATED PROCESS
bull Modern approach to coating tablets capsules or pellets bysurrounding them with a thin layer of polymeric material
bull Description of tablets Shape dictated by contour oforiginal core
bull Process Single stage process which involves spraying acoating solution containing the following
1 Polymer2 Solvent3 Plasticizer4 Colourant
The solution is sprayed onto a rotating tablet bed followedby drying which facilitates the removal of the solventleaving behind the deposition of thin film of coatingmaterials around each tablet
FILM COATING
AdvantagesProduce tablets in a single step process in
relatively short period of time Process enablesfunctional coatings to be incorporated into thedosage form
DisadvantagesThere are environmental and safety
implications of using organic solvent as well astheir financial expense
Types of film coating
A Immediate release
B Modified release
1Polymer
2PlasticizersPlasticizers are generally added to film coating formulations
to modify the physical properties of the polymer to make it
more usable One important property is their ability to
decrease film brittleness
Examples of plasticizers arepolyols such as polyethylene glycol 400
organic esters such as diethyl phthalate
oilsglycerides such as fractionated coconut oil
In general only water-miscible plasticizers can be used for aqueous-based
spray systems
31
3ColourantsAny permitted colourants in a film coat formula are invariably
water-insoluble colours (pigments) Pigments have certain
advantages over water-soluble colours they tend to be more
chemically stable towards light provide better opacity and
covering power and optimize the impermeability of a given film
to water vapour
Examples of colourants arebull iron oxide pigmentsbull titanium dioxidebull aluminum Lakes
32
4SolventsModern techniques now rely on water as a
polymer solvent because of the significant
drawbacks that readily became apparent with
the use of organic solvents
33
Nonentericmaterials eg
Hydroxypropyl methylcellulose (HPMC)Methylhydroxy ethyl cellulose (MHEC)Ethylcellulose (EC)Hydroxypropyl cellulose (HPC)Polyvinyl pyrrolidone (PVP)Sodium carboxymethyl cellulose (Sod CMC)Polyethylene glycols (PEG)Acrylate polymers eg Eudragit E
Enteric materials eg
Cellulose acetate phthalate (CAP)Acrylate polymers (Eudragit L S)Hydroxypropyl methylcellulose phthalate (HPMCP)Polyvinyl acetate phthalate (PVAP)
MATERIAL USED FOR FILM COATING
The vast majority of film coated tablets are produced by a process whichinvolves spraying of the coating material on to a bed of tablets AccelaCota is one example of equipment used for film coating
Accela Cota
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
1- Sealing (Waterproofing)This involved the application of one or more coats of awaterproofing substance in the form of alcoholic spray such as pharmaceutical Shellac (traditionally) or syntheticpolymers such as CAP( Unless a modified-release feature needs to be introduced the amount of the sealing coat applied should be carefully calculated so that there is no negative effect on the drug release characteristics in case of immediate release product)
(WHY Sealing)a- Sugar-coatings are aqueous formulations which allowwater to penetrate directly into the tablet core and thuspotentially affecting product stability and possibly causingpremature tablet disintegrationb- Application of many coats of partially or completelywater-insoluble polymers in this step enables sugar-coatedproduct to exhibit modified-release pattern (extendedreleaseor delayed enteric- release characteristics)
2 Subcoatingbull - Large quantities of sugar-coatings are usually
applied to the tablet core (typically increasing the tablet weight by ( 50- 100)
WHY bull In order to round off the tablet edge Much of
this material build-up occurs during this stage and is achieved by adding a bulking agent such as Calcium carbonate to the sucrose solution
bull - Antiadherents eg Talc may be added after partial drying to prevent sticking of the tablets together
3- Smoothingbull The subcoating stage results in tablets with rough
surfaces To facilitate the color application (which requires smooth surface) subcoated tablets are smoothed out by a thick sucrose syrup coating
4- Coloringbull Color coatings usually consist of thin sucrose
syrup containing the requisite coloring materials (water-soluble dyes or water-insoluble pigments may be used) This step must be done into a clean pan deprived of any residues from the previous operations
5- Polishingbull After the coloring step the tablet surfaces tend to
be smooth but somewhat dull in appearance To achieve glossy finish final stage involving application of waxes (beeswax carnuba wax) is employed
6- Printingbull Different tablets could be identified by
manufacturer logo product name dosage strength or other appropriate code For sugar-coated tablets such identification could be only achieved by printing process using special edible inks
Brufenreg POMbull Available in 200mg and 400mg
strength
Premarinreg POMbull Conjugated oestrogens 625mcg
(maroon) and 125mcg (yellow)
Colofac reg Pbull Mebeverine hydrochloride
100mg Round white sugar coated
Kalms reg GSLbull 45mg Hops powder90mg
Gentian powdered extract and 135mg Valerian powdered extract
EXAMPLE OF SUGAR COATED TABLETS
SUGAR COATED PROCESS
bull Modern approach to coating tablets capsules or pellets bysurrounding them with a thin layer of polymeric material
bull Description of tablets Shape dictated by contour oforiginal core
bull Process Single stage process which involves spraying acoating solution containing the following
1 Polymer2 Solvent3 Plasticizer4 Colourant
The solution is sprayed onto a rotating tablet bed followedby drying which facilitates the removal of the solventleaving behind the deposition of thin film of coatingmaterials around each tablet
FILM COATING
AdvantagesProduce tablets in a single step process in
relatively short period of time Process enablesfunctional coatings to be incorporated into thedosage form
DisadvantagesThere are environmental and safety
implications of using organic solvent as well astheir financial expense
Types of film coating
A Immediate release
B Modified release
1Polymer
2PlasticizersPlasticizers are generally added to film coating formulations
to modify the physical properties of the polymer to make it
more usable One important property is their ability to
decrease film brittleness
Examples of plasticizers arepolyols such as polyethylene glycol 400
organic esters such as diethyl phthalate
oilsglycerides such as fractionated coconut oil
In general only water-miscible plasticizers can be used for aqueous-based
spray systems
31
3ColourantsAny permitted colourants in a film coat formula are invariably
water-insoluble colours (pigments) Pigments have certain
advantages over water-soluble colours they tend to be more
chemically stable towards light provide better opacity and
covering power and optimize the impermeability of a given film
to water vapour
Examples of colourants arebull iron oxide pigmentsbull titanium dioxidebull aluminum Lakes
32
4SolventsModern techniques now rely on water as a
polymer solvent because of the significant
drawbacks that readily became apparent with
the use of organic solvents
33
Nonentericmaterials eg
Hydroxypropyl methylcellulose (HPMC)Methylhydroxy ethyl cellulose (MHEC)Ethylcellulose (EC)Hydroxypropyl cellulose (HPC)Polyvinyl pyrrolidone (PVP)Sodium carboxymethyl cellulose (Sod CMC)Polyethylene glycols (PEG)Acrylate polymers eg Eudragit E
Enteric materials eg
Cellulose acetate phthalate (CAP)Acrylate polymers (Eudragit L S)Hydroxypropyl methylcellulose phthalate (HPMCP)Polyvinyl acetate phthalate (PVAP)
MATERIAL USED FOR FILM COATING
The vast majority of film coated tablets are produced by a process whichinvolves spraying of the coating material on to a bed of tablets AccelaCota is one example of equipment used for film coating
Accela Cota
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
2 Subcoatingbull - Large quantities of sugar-coatings are usually
applied to the tablet core (typically increasing the tablet weight by ( 50- 100)
WHY bull In order to round off the tablet edge Much of
this material build-up occurs during this stage and is achieved by adding a bulking agent such as Calcium carbonate to the sucrose solution
bull - Antiadherents eg Talc may be added after partial drying to prevent sticking of the tablets together
3- Smoothingbull The subcoating stage results in tablets with rough
surfaces To facilitate the color application (which requires smooth surface) subcoated tablets are smoothed out by a thick sucrose syrup coating
4- Coloringbull Color coatings usually consist of thin sucrose
syrup containing the requisite coloring materials (water-soluble dyes or water-insoluble pigments may be used) This step must be done into a clean pan deprived of any residues from the previous operations
5- Polishingbull After the coloring step the tablet surfaces tend to
be smooth but somewhat dull in appearance To achieve glossy finish final stage involving application of waxes (beeswax carnuba wax) is employed
6- Printingbull Different tablets could be identified by
manufacturer logo product name dosage strength or other appropriate code For sugar-coated tablets such identification could be only achieved by printing process using special edible inks
Brufenreg POMbull Available in 200mg and 400mg
strength
Premarinreg POMbull Conjugated oestrogens 625mcg
(maroon) and 125mcg (yellow)
Colofac reg Pbull Mebeverine hydrochloride
100mg Round white sugar coated
Kalms reg GSLbull 45mg Hops powder90mg
Gentian powdered extract and 135mg Valerian powdered extract
EXAMPLE OF SUGAR COATED TABLETS
SUGAR COATED PROCESS
bull Modern approach to coating tablets capsules or pellets bysurrounding them with a thin layer of polymeric material
bull Description of tablets Shape dictated by contour oforiginal core
bull Process Single stage process which involves spraying acoating solution containing the following
1 Polymer2 Solvent3 Plasticizer4 Colourant
The solution is sprayed onto a rotating tablet bed followedby drying which facilitates the removal of the solventleaving behind the deposition of thin film of coatingmaterials around each tablet
FILM COATING
AdvantagesProduce tablets in a single step process in
relatively short period of time Process enablesfunctional coatings to be incorporated into thedosage form
DisadvantagesThere are environmental and safety
implications of using organic solvent as well astheir financial expense
Types of film coating
A Immediate release
B Modified release
1Polymer
2PlasticizersPlasticizers are generally added to film coating formulations
to modify the physical properties of the polymer to make it
more usable One important property is their ability to
decrease film brittleness
Examples of plasticizers arepolyols such as polyethylene glycol 400
organic esters such as diethyl phthalate
oilsglycerides such as fractionated coconut oil
In general only water-miscible plasticizers can be used for aqueous-based
spray systems
31
3ColourantsAny permitted colourants in a film coat formula are invariably
water-insoluble colours (pigments) Pigments have certain
advantages over water-soluble colours they tend to be more
chemically stable towards light provide better opacity and
covering power and optimize the impermeability of a given film
to water vapour
Examples of colourants arebull iron oxide pigmentsbull titanium dioxidebull aluminum Lakes
32
4SolventsModern techniques now rely on water as a
polymer solvent because of the significant
drawbacks that readily became apparent with
the use of organic solvents
33
Nonentericmaterials eg
Hydroxypropyl methylcellulose (HPMC)Methylhydroxy ethyl cellulose (MHEC)Ethylcellulose (EC)Hydroxypropyl cellulose (HPC)Polyvinyl pyrrolidone (PVP)Sodium carboxymethyl cellulose (Sod CMC)Polyethylene glycols (PEG)Acrylate polymers eg Eudragit E
Enteric materials eg
Cellulose acetate phthalate (CAP)Acrylate polymers (Eudragit L S)Hydroxypropyl methylcellulose phthalate (HPMCP)Polyvinyl acetate phthalate (PVAP)
MATERIAL USED FOR FILM COATING
The vast majority of film coated tablets are produced by a process whichinvolves spraying of the coating material on to a bed of tablets AccelaCota is one example of equipment used for film coating
Accela Cota
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
3- Smoothingbull The subcoating stage results in tablets with rough
surfaces To facilitate the color application (which requires smooth surface) subcoated tablets are smoothed out by a thick sucrose syrup coating
4- Coloringbull Color coatings usually consist of thin sucrose
syrup containing the requisite coloring materials (water-soluble dyes or water-insoluble pigments may be used) This step must be done into a clean pan deprived of any residues from the previous operations
5- Polishingbull After the coloring step the tablet surfaces tend to
be smooth but somewhat dull in appearance To achieve glossy finish final stage involving application of waxes (beeswax carnuba wax) is employed
6- Printingbull Different tablets could be identified by
manufacturer logo product name dosage strength or other appropriate code For sugar-coated tablets such identification could be only achieved by printing process using special edible inks
Brufenreg POMbull Available in 200mg and 400mg
strength
Premarinreg POMbull Conjugated oestrogens 625mcg
(maroon) and 125mcg (yellow)
Colofac reg Pbull Mebeverine hydrochloride
100mg Round white sugar coated
Kalms reg GSLbull 45mg Hops powder90mg
Gentian powdered extract and 135mg Valerian powdered extract
EXAMPLE OF SUGAR COATED TABLETS
SUGAR COATED PROCESS
bull Modern approach to coating tablets capsules or pellets bysurrounding them with a thin layer of polymeric material
bull Description of tablets Shape dictated by contour oforiginal core
bull Process Single stage process which involves spraying acoating solution containing the following
1 Polymer2 Solvent3 Plasticizer4 Colourant
The solution is sprayed onto a rotating tablet bed followedby drying which facilitates the removal of the solventleaving behind the deposition of thin film of coatingmaterials around each tablet
FILM COATING
AdvantagesProduce tablets in a single step process in
relatively short period of time Process enablesfunctional coatings to be incorporated into thedosage form
DisadvantagesThere are environmental and safety
implications of using organic solvent as well astheir financial expense
Types of film coating
A Immediate release
B Modified release
1Polymer
2PlasticizersPlasticizers are generally added to film coating formulations
to modify the physical properties of the polymer to make it
more usable One important property is their ability to
decrease film brittleness
Examples of plasticizers arepolyols such as polyethylene glycol 400
organic esters such as diethyl phthalate
oilsglycerides such as fractionated coconut oil
In general only water-miscible plasticizers can be used for aqueous-based
spray systems
31
3ColourantsAny permitted colourants in a film coat formula are invariably
water-insoluble colours (pigments) Pigments have certain
advantages over water-soluble colours they tend to be more
chemically stable towards light provide better opacity and
covering power and optimize the impermeability of a given film
to water vapour
Examples of colourants arebull iron oxide pigmentsbull titanium dioxidebull aluminum Lakes
32
4SolventsModern techniques now rely on water as a
polymer solvent because of the significant
drawbacks that readily became apparent with
the use of organic solvents
33
Nonentericmaterials eg
Hydroxypropyl methylcellulose (HPMC)Methylhydroxy ethyl cellulose (MHEC)Ethylcellulose (EC)Hydroxypropyl cellulose (HPC)Polyvinyl pyrrolidone (PVP)Sodium carboxymethyl cellulose (Sod CMC)Polyethylene glycols (PEG)Acrylate polymers eg Eudragit E
Enteric materials eg
Cellulose acetate phthalate (CAP)Acrylate polymers (Eudragit L S)Hydroxypropyl methylcellulose phthalate (HPMCP)Polyvinyl acetate phthalate (PVAP)
MATERIAL USED FOR FILM COATING
The vast majority of film coated tablets are produced by a process whichinvolves spraying of the coating material on to a bed of tablets AccelaCota is one example of equipment used for film coating
Accela Cota
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
5- Polishingbull After the coloring step the tablet surfaces tend to
be smooth but somewhat dull in appearance To achieve glossy finish final stage involving application of waxes (beeswax carnuba wax) is employed
6- Printingbull Different tablets could be identified by
manufacturer logo product name dosage strength or other appropriate code For sugar-coated tablets such identification could be only achieved by printing process using special edible inks
Brufenreg POMbull Available in 200mg and 400mg
strength
Premarinreg POMbull Conjugated oestrogens 625mcg
(maroon) and 125mcg (yellow)
Colofac reg Pbull Mebeverine hydrochloride
100mg Round white sugar coated
Kalms reg GSLbull 45mg Hops powder90mg
Gentian powdered extract and 135mg Valerian powdered extract
EXAMPLE OF SUGAR COATED TABLETS
SUGAR COATED PROCESS
bull Modern approach to coating tablets capsules or pellets bysurrounding them with a thin layer of polymeric material
bull Description of tablets Shape dictated by contour oforiginal core
bull Process Single stage process which involves spraying acoating solution containing the following
1 Polymer2 Solvent3 Plasticizer4 Colourant
The solution is sprayed onto a rotating tablet bed followedby drying which facilitates the removal of the solventleaving behind the deposition of thin film of coatingmaterials around each tablet
FILM COATING
AdvantagesProduce tablets in a single step process in
relatively short period of time Process enablesfunctional coatings to be incorporated into thedosage form
DisadvantagesThere are environmental and safety
implications of using organic solvent as well astheir financial expense
Types of film coating
A Immediate release
B Modified release
1Polymer
2PlasticizersPlasticizers are generally added to film coating formulations
to modify the physical properties of the polymer to make it
more usable One important property is their ability to
decrease film brittleness
Examples of plasticizers arepolyols such as polyethylene glycol 400
organic esters such as diethyl phthalate
oilsglycerides such as fractionated coconut oil
In general only water-miscible plasticizers can be used for aqueous-based
spray systems
31
3ColourantsAny permitted colourants in a film coat formula are invariably
water-insoluble colours (pigments) Pigments have certain
advantages over water-soluble colours they tend to be more
chemically stable towards light provide better opacity and
covering power and optimize the impermeability of a given film
to water vapour
Examples of colourants arebull iron oxide pigmentsbull titanium dioxidebull aluminum Lakes
32
4SolventsModern techniques now rely on water as a
polymer solvent because of the significant
drawbacks that readily became apparent with
the use of organic solvents
33
Nonentericmaterials eg
Hydroxypropyl methylcellulose (HPMC)Methylhydroxy ethyl cellulose (MHEC)Ethylcellulose (EC)Hydroxypropyl cellulose (HPC)Polyvinyl pyrrolidone (PVP)Sodium carboxymethyl cellulose (Sod CMC)Polyethylene glycols (PEG)Acrylate polymers eg Eudragit E
Enteric materials eg
Cellulose acetate phthalate (CAP)Acrylate polymers (Eudragit L S)Hydroxypropyl methylcellulose phthalate (HPMCP)Polyvinyl acetate phthalate (PVAP)
MATERIAL USED FOR FILM COATING
The vast majority of film coated tablets are produced by a process whichinvolves spraying of the coating material on to a bed of tablets AccelaCota is one example of equipment used for film coating
Accela Cota
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
Brufenreg POMbull Available in 200mg and 400mg
strength
Premarinreg POMbull Conjugated oestrogens 625mcg
(maroon) and 125mcg (yellow)
Colofac reg Pbull Mebeverine hydrochloride
100mg Round white sugar coated
Kalms reg GSLbull 45mg Hops powder90mg
Gentian powdered extract and 135mg Valerian powdered extract
EXAMPLE OF SUGAR COATED TABLETS
SUGAR COATED PROCESS
bull Modern approach to coating tablets capsules or pellets bysurrounding them with a thin layer of polymeric material
bull Description of tablets Shape dictated by contour oforiginal core
bull Process Single stage process which involves spraying acoating solution containing the following
1 Polymer2 Solvent3 Plasticizer4 Colourant
The solution is sprayed onto a rotating tablet bed followedby drying which facilitates the removal of the solventleaving behind the deposition of thin film of coatingmaterials around each tablet
FILM COATING
AdvantagesProduce tablets in a single step process in
relatively short period of time Process enablesfunctional coatings to be incorporated into thedosage form
DisadvantagesThere are environmental and safety
implications of using organic solvent as well astheir financial expense
Types of film coating
A Immediate release
B Modified release
1Polymer
2PlasticizersPlasticizers are generally added to film coating formulations
to modify the physical properties of the polymer to make it
more usable One important property is their ability to
decrease film brittleness
Examples of plasticizers arepolyols such as polyethylene glycol 400
organic esters such as diethyl phthalate
oilsglycerides such as fractionated coconut oil
In general only water-miscible plasticizers can be used for aqueous-based
spray systems
31
3ColourantsAny permitted colourants in a film coat formula are invariably
water-insoluble colours (pigments) Pigments have certain
advantages over water-soluble colours they tend to be more
chemically stable towards light provide better opacity and
covering power and optimize the impermeability of a given film
to water vapour
Examples of colourants arebull iron oxide pigmentsbull titanium dioxidebull aluminum Lakes
32
4SolventsModern techniques now rely on water as a
polymer solvent because of the significant
drawbacks that readily became apparent with
the use of organic solvents
33
Nonentericmaterials eg
Hydroxypropyl methylcellulose (HPMC)Methylhydroxy ethyl cellulose (MHEC)Ethylcellulose (EC)Hydroxypropyl cellulose (HPC)Polyvinyl pyrrolidone (PVP)Sodium carboxymethyl cellulose (Sod CMC)Polyethylene glycols (PEG)Acrylate polymers eg Eudragit E
Enteric materials eg
Cellulose acetate phthalate (CAP)Acrylate polymers (Eudragit L S)Hydroxypropyl methylcellulose phthalate (HPMCP)Polyvinyl acetate phthalate (PVAP)
MATERIAL USED FOR FILM COATING
The vast majority of film coated tablets are produced by a process whichinvolves spraying of the coating material on to a bed of tablets AccelaCota is one example of equipment used for film coating
Accela Cota
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
SUGAR COATED PROCESS
bull Modern approach to coating tablets capsules or pellets bysurrounding them with a thin layer of polymeric material
bull Description of tablets Shape dictated by contour oforiginal core
bull Process Single stage process which involves spraying acoating solution containing the following
1 Polymer2 Solvent3 Plasticizer4 Colourant
The solution is sprayed onto a rotating tablet bed followedby drying which facilitates the removal of the solventleaving behind the deposition of thin film of coatingmaterials around each tablet
FILM COATING
AdvantagesProduce tablets in a single step process in
relatively short period of time Process enablesfunctional coatings to be incorporated into thedosage form
DisadvantagesThere are environmental and safety
implications of using organic solvent as well astheir financial expense
Types of film coating
A Immediate release
B Modified release
1Polymer
2PlasticizersPlasticizers are generally added to film coating formulations
to modify the physical properties of the polymer to make it
more usable One important property is their ability to
decrease film brittleness
Examples of plasticizers arepolyols such as polyethylene glycol 400
organic esters such as diethyl phthalate
oilsglycerides such as fractionated coconut oil
In general only water-miscible plasticizers can be used for aqueous-based
spray systems
31
3ColourantsAny permitted colourants in a film coat formula are invariably
water-insoluble colours (pigments) Pigments have certain
advantages over water-soluble colours they tend to be more
chemically stable towards light provide better opacity and
covering power and optimize the impermeability of a given film
to water vapour
Examples of colourants arebull iron oxide pigmentsbull titanium dioxidebull aluminum Lakes
32
4SolventsModern techniques now rely on water as a
polymer solvent because of the significant
drawbacks that readily became apparent with
the use of organic solvents
33
Nonentericmaterials eg
Hydroxypropyl methylcellulose (HPMC)Methylhydroxy ethyl cellulose (MHEC)Ethylcellulose (EC)Hydroxypropyl cellulose (HPC)Polyvinyl pyrrolidone (PVP)Sodium carboxymethyl cellulose (Sod CMC)Polyethylene glycols (PEG)Acrylate polymers eg Eudragit E
Enteric materials eg
Cellulose acetate phthalate (CAP)Acrylate polymers (Eudragit L S)Hydroxypropyl methylcellulose phthalate (HPMCP)Polyvinyl acetate phthalate (PVAP)
MATERIAL USED FOR FILM COATING
The vast majority of film coated tablets are produced by a process whichinvolves spraying of the coating material on to a bed of tablets AccelaCota is one example of equipment used for film coating
Accela Cota
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
bull Modern approach to coating tablets capsules or pellets bysurrounding them with a thin layer of polymeric material
bull Description of tablets Shape dictated by contour oforiginal core
bull Process Single stage process which involves spraying acoating solution containing the following
1 Polymer2 Solvent3 Plasticizer4 Colourant
The solution is sprayed onto a rotating tablet bed followedby drying which facilitates the removal of the solventleaving behind the deposition of thin film of coatingmaterials around each tablet
FILM COATING
AdvantagesProduce tablets in a single step process in
relatively short period of time Process enablesfunctional coatings to be incorporated into thedosage form
DisadvantagesThere are environmental and safety
implications of using organic solvent as well astheir financial expense
Types of film coating
A Immediate release
B Modified release
1Polymer
2PlasticizersPlasticizers are generally added to film coating formulations
to modify the physical properties of the polymer to make it
more usable One important property is their ability to
decrease film brittleness
Examples of plasticizers arepolyols such as polyethylene glycol 400
organic esters such as diethyl phthalate
oilsglycerides such as fractionated coconut oil
In general only water-miscible plasticizers can be used for aqueous-based
spray systems
31
3ColourantsAny permitted colourants in a film coat formula are invariably
water-insoluble colours (pigments) Pigments have certain
advantages over water-soluble colours they tend to be more
chemically stable towards light provide better opacity and
covering power and optimize the impermeability of a given film
to water vapour
Examples of colourants arebull iron oxide pigmentsbull titanium dioxidebull aluminum Lakes
32
4SolventsModern techniques now rely on water as a
polymer solvent because of the significant
drawbacks that readily became apparent with
the use of organic solvents
33
Nonentericmaterials eg
Hydroxypropyl methylcellulose (HPMC)Methylhydroxy ethyl cellulose (MHEC)Ethylcellulose (EC)Hydroxypropyl cellulose (HPC)Polyvinyl pyrrolidone (PVP)Sodium carboxymethyl cellulose (Sod CMC)Polyethylene glycols (PEG)Acrylate polymers eg Eudragit E
Enteric materials eg
Cellulose acetate phthalate (CAP)Acrylate polymers (Eudragit L S)Hydroxypropyl methylcellulose phthalate (HPMCP)Polyvinyl acetate phthalate (PVAP)
MATERIAL USED FOR FILM COATING
The vast majority of film coated tablets are produced by a process whichinvolves spraying of the coating material on to a bed of tablets AccelaCota is one example of equipment used for film coating
Accela Cota
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
AdvantagesProduce tablets in a single step process in
relatively short period of time Process enablesfunctional coatings to be incorporated into thedosage form
DisadvantagesThere are environmental and safety
implications of using organic solvent as well astheir financial expense
Types of film coating
A Immediate release
B Modified release
1Polymer
2PlasticizersPlasticizers are generally added to film coating formulations
to modify the physical properties of the polymer to make it
more usable One important property is their ability to
decrease film brittleness
Examples of plasticizers arepolyols such as polyethylene glycol 400
organic esters such as diethyl phthalate
oilsglycerides such as fractionated coconut oil
In general only water-miscible plasticizers can be used for aqueous-based
spray systems
31
3ColourantsAny permitted colourants in a film coat formula are invariably
water-insoluble colours (pigments) Pigments have certain
advantages over water-soluble colours they tend to be more
chemically stable towards light provide better opacity and
covering power and optimize the impermeability of a given film
to water vapour
Examples of colourants arebull iron oxide pigmentsbull titanium dioxidebull aluminum Lakes
32
4SolventsModern techniques now rely on water as a
polymer solvent because of the significant
drawbacks that readily became apparent with
the use of organic solvents
33
Nonentericmaterials eg
Hydroxypropyl methylcellulose (HPMC)Methylhydroxy ethyl cellulose (MHEC)Ethylcellulose (EC)Hydroxypropyl cellulose (HPC)Polyvinyl pyrrolidone (PVP)Sodium carboxymethyl cellulose (Sod CMC)Polyethylene glycols (PEG)Acrylate polymers eg Eudragit E
Enteric materials eg
Cellulose acetate phthalate (CAP)Acrylate polymers (Eudragit L S)Hydroxypropyl methylcellulose phthalate (HPMCP)Polyvinyl acetate phthalate (PVAP)
MATERIAL USED FOR FILM COATING
The vast majority of film coated tablets are produced by a process whichinvolves spraying of the coating material on to a bed of tablets AccelaCota is one example of equipment used for film coating
Accela Cota
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
1Polymer
2PlasticizersPlasticizers are generally added to film coating formulations
to modify the physical properties of the polymer to make it
more usable One important property is their ability to
decrease film brittleness
Examples of plasticizers arepolyols such as polyethylene glycol 400
organic esters such as diethyl phthalate
oilsglycerides such as fractionated coconut oil
In general only water-miscible plasticizers can be used for aqueous-based
spray systems
31
3ColourantsAny permitted colourants in a film coat formula are invariably
water-insoluble colours (pigments) Pigments have certain
advantages over water-soluble colours they tend to be more
chemically stable towards light provide better opacity and
covering power and optimize the impermeability of a given film
to water vapour
Examples of colourants arebull iron oxide pigmentsbull titanium dioxidebull aluminum Lakes
32
4SolventsModern techniques now rely on water as a
polymer solvent because of the significant
drawbacks that readily became apparent with
the use of organic solvents
33
Nonentericmaterials eg
Hydroxypropyl methylcellulose (HPMC)Methylhydroxy ethyl cellulose (MHEC)Ethylcellulose (EC)Hydroxypropyl cellulose (HPC)Polyvinyl pyrrolidone (PVP)Sodium carboxymethyl cellulose (Sod CMC)Polyethylene glycols (PEG)Acrylate polymers eg Eudragit E
Enteric materials eg
Cellulose acetate phthalate (CAP)Acrylate polymers (Eudragit L S)Hydroxypropyl methylcellulose phthalate (HPMCP)Polyvinyl acetate phthalate (PVAP)
MATERIAL USED FOR FILM COATING
The vast majority of film coated tablets are produced by a process whichinvolves spraying of the coating material on to a bed of tablets AccelaCota is one example of equipment used for film coating
Accela Cota
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
2PlasticizersPlasticizers are generally added to film coating formulations
to modify the physical properties of the polymer to make it
more usable One important property is their ability to
decrease film brittleness
Examples of plasticizers arepolyols such as polyethylene glycol 400
organic esters such as diethyl phthalate
oilsglycerides such as fractionated coconut oil
In general only water-miscible plasticizers can be used for aqueous-based
spray systems
31
3ColourantsAny permitted colourants in a film coat formula are invariably
water-insoluble colours (pigments) Pigments have certain
advantages over water-soluble colours they tend to be more
chemically stable towards light provide better opacity and
covering power and optimize the impermeability of a given film
to water vapour
Examples of colourants arebull iron oxide pigmentsbull titanium dioxidebull aluminum Lakes
32
4SolventsModern techniques now rely on water as a
polymer solvent because of the significant
drawbacks that readily became apparent with
the use of organic solvents
33
Nonentericmaterials eg
Hydroxypropyl methylcellulose (HPMC)Methylhydroxy ethyl cellulose (MHEC)Ethylcellulose (EC)Hydroxypropyl cellulose (HPC)Polyvinyl pyrrolidone (PVP)Sodium carboxymethyl cellulose (Sod CMC)Polyethylene glycols (PEG)Acrylate polymers eg Eudragit E
Enteric materials eg
Cellulose acetate phthalate (CAP)Acrylate polymers (Eudragit L S)Hydroxypropyl methylcellulose phthalate (HPMCP)Polyvinyl acetate phthalate (PVAP)
MATERIAL USED FOR FILM COATING
The vast majority of film coated tablets are produced by a process whichinvolves spraying of the coating material on to a bed of tablets AccelaCota is one example of equipment used for film coating
Accela Cota
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
3ColourantsAny permitted colourants in a film coat formula are invariably
water-insoluble colours (pigments) Pigments have certain
advantages over water-soluble colours they tend to be more
chemically stable towards light provide better opacity and
covering power and optimize the impermeability of a given film
to water vapour
Examples of colourants arebull iron oxide pigmentsbull titanium dioxidebull aluminum Lakes
32
4SolventsModern techniques now rely on water as a
polymer solvent because of the significant
drawbacks that readily became apparent with
the use of organic solvents
33
Nonentericmaterials eg
Hydroxypropyl methylcellulose (HPMC)Methylhydroxy ethyl cellulose (MHEC)Ethylcellulose (EC)Hydroxypropyl cellulose (HPC)Polyvinyl pyrrolidone (PVP)Sodium carboxymethyl cellulose (Sod CMC)Polyethylene glycols (PEG)Acrylate polymers eg Eudragit E
Enteric materials eg
Cellulose acetate phthalate (CAP)Acrylate polymers (Eudragit L S)Hydroxypropyl methylcellulose phthalate (HPMCP)Polyvinyl acetate phthalate (PVAP)
MATERIAL USED FOR FILM COATING
The vast majority of film coated tablets are produced by a process whichinvolves spraying of the coating material on to a bed of tablets AccelaCota is one example of equipment used for film coating
Accela Cota
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
4SolventsModern techniques now rely on water as a
polymer solvent because of the significant
drawbacks that readily became apparent with
the use of organic solvents
33
Nonentericmaterials eg
Hydroxypropyl methylcellulose (HPMC)Methylhydroxy ethyl cellulose (MHEC)Ethylcellulose (EC)Hydroxypropyl cellulose (HPC)Polyvinyl pyrrolidone (PVP)Sodium carboxymethyl cellulose (Sod CMC)Polyethylene glycols (PEG)Acrylate polymers eg Eudragit E
Enteric materials eg
Cellulose acetate phthalate (CAP)Acrylate polymers (Eudragit L S)Hydroxypropyl methylcellulose phthalate (HPMCP)Polyvinyl acetate phthalate (PVAP)
MATERIAL USED FOR FILM COATING
The vast majority of film coated tablets are produced by a process whichinvolves spraying of the coating material on to a bed of tablets AccelaCota is one example of equipment used for film coating
Accela Cota
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
Nonentericmaterials eg
Hydroxypropyl methylcellulose (HPMC)Methylhydroxy ethyl cellulose (MHEC)Ethylcellulose (EC)Hydroxypropyl cellulose (HPC)Polyvinyl pyrrolidone (PVP)Sodium carboxymethyl cellulose (Sod CMC)Polyethylene glycols (PEG)Acrylate polymers eg Eudragit E
Enteric materials eg
Cellulose acetate phthalate (CAP)Acrylate polymers (Eudragit L S)Hydroxypropyl methylcellulose phthalate (HPMCP)Polyvinyl acetate phthalate (PVAP)
MATERIAL USED FOR FILM COATING
The vast majority of film coated tablets are produced by a process whichinvolves spraying of the coating material on to a bed of tablets AccelaCota is one example of equipment used for film coating
Accela Cota
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
The vast majority of film coated tablets are produced by a process whichinvolves spraying of the coating material on to a bed of tablets AccelaCota is one example of equipment used for film coating
Accela Cota
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
Accela Cota
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
Film coatingTablet appearance
Retains shape of original core Small weight increase of 2-3 due to coating material logo or lsquobreak linesrsquo possible
Process Can be automated eg Accela CotaEasy training operation Single stage processEasily adaptable for controlled release allows for functional coatings
Sugar coatingTablet appearance
Rounded with high degree of polishLarger weight increase 30-50 due to coating materialLogo or lsquobreak linesrsquo are possible
Process Difficult to automated eg traditional coating pan Considerable training operation required Multistage process Not able to be used for controlled release apart from enteric coating
DIFFERENCE BETWEEN FILM COATNIG amp SUGAR COATING
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
use of compression to form coat around a pre‐formed core
used mainly to separate chemically incompatible materialsalso dual release patterns possible
PRESS COATING
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
To separate chemically incompatible materials one or more being
placed in the core and the other(s) in the coating layer
However there is still an interface contact left between the two
layers
In cases where even this is important then the process of pre
coating can be taken one stage further
It is possible to apply two press coatings to a tablet core using
suitable equipment
This equipment produces press-coated tablets with perfect
separation between active core and coating as the two can be
separated by an inert middle layer
40
press coating is used
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
COATING DEFECT
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
- Tablet coating
- Slide Number 2
- Aspects of tablet coating
- Aspects of tablet coating
- Aspects of tablet coating
- Slide Number 6
- Type of tablet coating
- MANUFACTURE OF PHARMACEUTICAL TABLET COATING
- Slide Number 9
- Slide Number 10
- Slide Number 11
- Slide Number 12
- Slide Number 13
- Slide Number 14
- Slide Number 15
- Slide Number 16
- Slide Number 17
- Slide Number 18
- Slide Number 19
- Slide Number 20
- Slide Number 21
- Slide Number 22
- Slide Number 23
- Slide Number 24
- Slide Number 25
- Slide Number 26
- Slide Number 27
- Slide Number 28
- Slide Number 29
- Slide Number 30
- Slide Number 31
- Slide Number 32
- Slide Number 33
- Slide Number 34
- Slide Number 35
- Slide Number 36
- Slide Number 37
- Slide Number 38
- Slide Number 39
- Slide Number 40
- COATING DEFECT
- Slide Number 42
- Slide Number 43
- Slide Number 44
- Slide Number 45
-
