Preparation of qualitative & quantitative

department with equipments for

Presented byPatel Jignesh. P.Patel Jignesh. P.

Guided byMrs Anita PatelMrs Anita Patel

Department of pharmaceuticsNootan pharmacy college,

visnagar

layoutlayout

SOLID DOSAGE FORMSOLID DOSAGE FORM

List of content......

• Introduction• Plant layout• Equipments• References

BUILDING & FACILITIES• Designed according to GMP practices which

ensures …….

Prevention of cross contamination Proper air handling systems. Proper cleaning & sanitary facilities. Proper Lighting Proper Plumbing Proper washing etc.

Layout:

It is the organized properly planned INTERDEPARTMENT and INTRADEPARTMENT arrangements.

PROPER LAYOUT:

Increases productivity

Helps in proper utilization of - MAN - MATERIAL - MONEY - MACHINES

TYPES OF LAYOUT

layout With

1) crossover traffic 2) circular flow 3) Parallel flow

Area : 60+20 sq.meter

Deduster

30+10 sq.meter

30 Pascal

10 Pascal

20 Pascal

15 Pascal

15 Pascal

Temp. 25+/-5

Humidity :

55+/-10%RH

CROSS OVER TRAFFIC

Are

a : 6

0+20

sq.

met

er

Temp. 25+/-5

Humidity : 55+/-10%RH

30+10 sq.meter

Circular flow

Parallel flow

For Uncoated TabletFor Coating Section

For Basic Installation

Sq.mtrs. For Ancillary Area

Sq.mtrs.

60

30

20

10

AREAAREA REQUIREMENTREQUIREMENT

ENVIRONMENTENVIRONMENT REQUIREMENTREQUIREMENTTemperature : 25 ± 5 CHumidity : 55 ± 10 %RHPressure in Ware House Area: 10 PascalPressure in Weighing Area : 20 PascalPressure in Tableting Area : 15 PascalPressure in Central Corridor : 30 Pascal

Granulation:Granulation:

• Wet Granulation• Direct Compression• Dry Granulation

– Slugging– Roll Compaction

High Shear Granulator

Diosna GranulatorGral Mixer/Granulator

Granulator with Drying Facility

Fluidized Bed GranulatorDay Nauta Mixer Processor Double cone/Twin Shell ProcessorTopo Granulator

Special Granulator

Roto GranulatorMarumerizer

WET GRANULATION: some equipmentWET GRANULATION: some equipment

Most commonly used granulator:

Rapid mixer granulator

Fluidised bed granulator

Typical Time Sequence

Mixing – 2 minutes

Granulation – 8 minutes

Discharge – 1 minutes

Rapid Mixer Granulator (RMG)Rapid Mixer Granulator (RMG)

Rapid mixing granulator: (RMG)Rapid mixing granulator: (RMG)

Advantage Advantage

• Mixing, Massing ,Granulation in a single equipment within few minutes

• End point monitor needed

• Mixing, Massing ,Granulation in a single equipment within few minutes

• End point monitor needed

Disadvantage:Disadvantage:

Designs of FB granulatorsDesigns of FB granulators

• Top spray• Bottom spray• Rotating disc

granulator

16

Suction Fan

Fabric Filter Bag

Granulating solution

Product Bed

Spray NozzleAir Filter

Air Heater

Fluidized bed granulator:

Advantage

• One unit so saving labour cost, transfer loses and time• 2-6 time greater heat transfer than tray dryer• Uniform drying….prevent mottling.• Process can be automated once parameters optimizedDisadvantage

• Expensive • Multiple process variable• Filter clocking, demixing, electrostatic charge, solvent

explosion

Drying:

Fluidised bed Dryer:

Tray dryerTray dryer• No. of trays in one close cabinet into which

heated air is circulated.• Drying time depends on

– Temperature of heated air – Depth of bed – Circulation of heated air – Distance between trays

Milling:Milling:

Multi mill

BlendingBlending

Tabletting:

Tabletting:

Tablet machine is regulated by..

• Number of tooling sets

• Number of compression station

• Rotational speed of the press

Punch& Die

Hopper

Cam tracks

Auxillary equipment:Auxillary equipment:

• Mechanised feeder

• Tablet Deduster

• Granule level sensor

• Mechanised feeder

• Tablet Deduster

• Granule level sensor

FETTE PREFECTA 2000 COOLTEXFETTE PREFECTA 2000 COOLTEX

• Enables the compression of the substance at low temp

• This cooling unit allows for the preparation by compression of suppositories, enzyme preparations or thermo sensitive active ingredients.

• -60C temp is attainable by the press.

Recent addition in tablet press system:Recent addition in tablet press system:

Coating :

TABLET COATING:TABLET COATING:

OBJECTIVES OF COATING:-• To mask taste ,odor, colour , of the drug.• To provide physical & chemical protection to the

drug.• To control release of the drug from the tablet.• To protect drug from gastric environment.• To avoid chemical incompatibilities.• To provide physical elegance.

Standard coating pan

INLET AIR

Exhaust Air

modification in standard coating pans:

A) pellegrini pan:-it has a baffled pan & a diffuser that distributes the drying air uniformly over the tablet bed surface.

B) Immersion tube system:-A tube is immersed in the tablet bed. the tube delivers the heated air & a spray nozzle is built in the tip of the tube.

C) Immersion sword system:- Drying air is introduced through a perforated metal sword device that is immersed in the tablet bed.

Perforated coating pan:

1. Accela cota & Hi coater system

2. Driacoater:

3. Glatt coater:

4. Fluidised bed coater

Innovation….Innovation….GLATT COATER:

Latest Perforated pan with airflow facility both from inside to outside & alternatively from outside to inside.

Drying air can be directed from inside the drum through the tablet bed & out an Exhaust duct.

Evaluation of tablets: ( I.P.Q.C Tests)

Evaluation of tablets: ( I.P.Q.C Tests)

1) Hardness test2) Friability test3) Disintegration test4) Dissolution tests5) Weight variation6) Content uniformity

Hardness test:Monsanto hardness tester:

Advantage:- convenient

low priced

Drawback:

- Hardness obtained is lesser by 1.5-1.7% compared to later developed instrument.

-Instrument use spring which has no standard of compression

Pfizer hardness tester:- Use mechanical principle of plier (instrument for holding things tightly)

- Reading are recorded on a dial.

Strong cobb tester: -Disadvantage:

- Air pump get damaged.

Need frequent services

-Calibration process is

difficult

Fribility test• Tablets are subjected to combine effect of

shock and abrasion.

Rotation Speed : 25 RPM

No. of Rotations : 100

Dropping Height : 6 inch

Loss in weight after de dusting should less than 0.5-1.0%

Limit :

• - Basket assembly with 6 glass tubes, 3 inches long, open at top & 10 # screen at bottom end.

• - Moves up and down through distance of 5-6 cm at frequency of 28-32 cycles per minute

• - Basket assembly with 6 glass tubes, 3 inches long, open at top & 10 # screen at bottom end.

• - Moves up and down through distance of 5-6 cm at frequency of 28-32 cycles per minute

Disintegration tester:

WEIGHT VARIATION TEST:

Avg. weight of tablets(mg)

Maximum % difference allowed

130 or less 10

130-324 7.5

> 324 5

• WEIGHT VARIATION TOLERANCES FOR UNCOATED TABLETS (USP):

PackagingPackaging

Leak test:Leak test:

Packed final product is placed in to close jar containing water.

Vacuum is applied for 30 min. and observe for bubble formation.

Instead of vacuum, pressure may be applied and after test strip or blister was opened to observe wetting of tablets.

LABELLING REQUIREMENTS FOR TABLETS:LABELLING REQUIREMENTS FOR TABLETS:

• The label states that:The quantity of active ingredient

• Batch number,• Date of manufacturing• Date of expiry.• Storage condition• Information about type of dosage form• Such as SR , IR , Mouth dissolving. Enteric coated etc.

Packaging label:

Printed packaging materialIncludes formula, Dosage, storage condition, instruction, mfg lic. Number Not changed from batch to batch.

Stereo part includes batch no, Mfg. date, Exp date, MRP Changed depends on batch & production date.

• The Theory and Practice of Industrial Pharmacy by Leon Lachman• Pharmaceutical Dosage Forms : TABLETS Vol. 3• Encyclopedia of Pharmaceutical Technology, Marcel Dekker, Volume-6• Pharmaceutical Sciences by Remington• Pharmaceutical dosage form by Aulton• How to Practice GMPs by P.P.Sharma• The eastern pharmacist 2001• The Indian pharmacist• Pharma times-Aug-2006• Manufacturing chemist• Tabmach tools pvt limited.• Indian pharmaceutical congress-2007, Expo.• www.wikipedia.com• www.pharmatech.com• www.bioprocess.com• www.sotex.com• www.pharmamachine.com• www.stablemicrosystem.com• www.celisinstrument.com• www.tablettesting.com• www.mocoa.com• www.rpc-marketrasen.co.uk

REFERENCES:

THANKS