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    Tablet:Problems in tablet manufacturingFrom Pharmpedia

    Next Page: Quality control tests for tablets

    Previous Page: Tablet coating

    Contents[hide]

    1Introductiono 1.1Cappingo 1.2Lamination / Laminatingo 1.3Chippingo 1.4Crackingo 1.5Sticking / Filmingo 1.6Pickingo 1.7Bindingo 1.8Mottlingo 1.9Doubleimpression2Problemsandremedies fortabletcoatingo 2.1Blisteringo 2.2Chippingo 2.3Crateringo 2.4Pickingo 2.5Pittingo 2.6Bloomingo 2.7Blushingo 2.8Colour variationo 2.9Infillingo 2.10Orangepeel/Roughnesso 2.11Cracking/Splitting3KeyPhrases

    Introduction(62,63)

    Anidealtabletshouldbe free fromany visualdefector functionaldefect. Theadvancements

    andinnovationsintabletmanufacturehavenotdecreasedtheproblems,oftenencounteredintheproduction,insteadhaveincreasedtheproblems,mainlybecauseofthecomplexities

    oftabletpresses;and/orthegreaterdemandsof quality.

    Anindustrialpharmacistusuallyencountersnumberofproblemsduringmanufacturing.Majorityof visualdefectsareduetoinadequate finesorinadequatemoistureinthegranules

    ready forcompressionordueto faultymachinesetting. Functionaldefectsaredueto faulty

    formulation.Solvingmanyofthemanufacturingproblemsrequiresanindepthknowledgeofgranulationprocessingandtabletpresses,andisacquiredonlythroughanexhaustive

    studyandarichexperience.

    Here,wewilldiscusstheimperfections foundintabletsalongwiththeircausesandrelatedremedies. Theimperfectionsareknownas: VISUALDEFECTSandtheyareeitherrelatedto

    imperfectionsinanyoneormoreofthe following factors:

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    I. TabletingProcess

    II.Excipient

    III.Machine

    The defects related to Tableting Process are as follows:

    i)CAPPING:Itispartialorcompleteseparationofthetoporbottomoftabletdueair-entrapmentinthegranularmaterial.

    ii)LAMINATION:Itisseparationoftabletintotwoormorelayersduetoair-entrapmentinthegranularmaterial.

    iii)CRACKING:Itisduetorapidexpansionoftabletswhendeepconcavepunchesareused.

    The defects related to Excipient are as follows:

    iv)CHIPPING:Itisdueto verydrygranules.

    v)STICKING:Itistheadhesionofgranulationmaterialtothediewall

    vi)PICKING:Itistheremovalofmaterial fromthesurfaceoftabletanditsadherancetothe faceofpunch.

    vii)BINDING

    Theseproblems(v, vi, vii)areduetomoreamountofbinderinthegranulesorwetgranules.

    The defect related to more than one factor:

    viii)MOTTLING:Itiseitherduetoanyoneormoreofthese factors:Duetoacoloured

    drug,whichhasdifferentcolourthantherestofthegranularmaterial?(Excipient-related);

    impropermixingofgranularmaterial(Process-related);dirtinthegranularmaterialoron

    punch faces;oilspotsbyusingoilylubricant.The defect related to Machine

    ix)DOUBLEIMPRESSION:Itisdueto freerotationofthepunches,whichhavesomeengravingonthepunch faces.

    Further,inthissection,eachproblemisdescribedalong-withitscausesandremedieswhich

    mayberelatedtoeitherof formulation(granulation)orofmachine(dies,punchesandentiretabletpress).

    Capping

    (1,5)

    Cappingisthetermused,whentheupperorlowersegmentofthetabletseparateshorizontally,eitherpartiallyorcompletely fromthemainbodyofatabletandcomesoffasacap,duringejection fromthetabletpress,orduringsubsequenthandling.

    Reason:Cappingisusuallyduetotheairentrapmentinacompactduringcompression,

    andsubsequentexpansionoftabletonejectionofatablet fromadie.

    TABLE.27. THECAUSES AND REMEDIESOF CAPPING RELATED TO FORMULATION

    (GRANULATION)

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    Sr.No.

    CAUSES REMEDIES

    1.Largeamountof finesinthegranulation

    Removesomeorall finesthrough100to200meshscreen

    2.Toodryor verylowmoisturecontent(leadingtolossofproper

    bindingaction).

    Moistenthegranulessuitably. Addhygroscopicsubstancee.g.:sorbitol,methyl-celluloseorPEG-

    4000.

    3. Notthoroughlydriedgranules. Drythegranulesproperly.

    4.Insufficientamountofbinderor

    improperbinder.

    IncreasingthemountofbinderOR

    Addingdrybindersuchaspre-gelatinizedstarch,

    gumacacia,powderedsorbitol,PVP,hydrophilic

    silicaorpowderedsugar.

    5. Insufficientorimproperlubricant.Increasetheamountoflubricantorchangethe

    typeoflubricant.

    6.Granularmasstoocoldto

    compress firm.Compressatroomtemperature.

    TABLE.28. THECAUSES AND REMEDIESOF CAPPING RELATED TO MACHINE(DIES,

    PUNCHES AND TABLET PRESS)

    Sr.No.

    CAUSES REMEDIES

    1. Poorly finisheddiesPolishdiesproperly.Investigateother

    steelsorothermaterials.

    2.Deepconcavepunchesorbeveled-edge

    facesofpunches.Use flatpunches.

    3.Lowerpunchremainsbelowthe faceof

    dieduringejection.Makepropersettingoflowerpunchduring

    ejection.

    4. Incorrectadjustmentofsweep-offblade.Adjustsweep-offbladecorrectlyto

    facilitateproperejection.

    5. Highturretspeed.Reducespeedofturret(Increasedwell

    time).

    Lamination / Laminating

    (1,5)

    Definition: Laminationistheseparationofatabletintotwoormoredistincthorizontallayers.

    Reason: Airentrapmentduringcompressionandsubsequentreleaseonejection.

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    Theconditionisexaggeratedbyhigherspeedofturret.

    TABLE.29. THECAUSES AND REMEDIESOF LAMINATION RELATED TO FORMULATION(GRANULATION)

    Sr.No.

    CAUSESREMEDIES

    1. OilyorwaxymaterialsingranulesModifymixingprocess. Addadsorbentorabsorbent.

    2.Toomuchofhydrophobiclubricante.g.:Magnesium-stearate.

    Usealessamountoflubricantorchangethetypeoflubricant.

    TABLE.30. TheCausesand RemediesofLaminationrelatedtoMACHINE(Dies,Punchesand

    TabletPress)

    Sr.No.

    CAUSES REMEDIES

    1.

    Rapidrelaxationoftheperipheral

    regionsofatablet,onejection fromadie.

    Usetapereddies,i.e.upperpartofthedie

    borehasanoutwardtaperof3to5.

    2. RapiddecompressionUsepre-compressionstep. Reduceturretspeedandreducethe finalcompression

    pressure.

    Chipping

    (1)

    Definition: Chippingisdefinedasthebreakingoftabletedges,whilethetabletleavesthepressorduringsubsequenthandlingandcoatingoperations.

    Reason:Incorrectmachinesettings,speciallymis-setejectiontake-off.

    TABLE.31. THECAUSES AND REMEDIESOF CHIPPING RELATED TO FORMULATION

    (GRANULATION) ARE AS FOLLOWS

    Sr.No.

    CAUSES REMEDIES

    1. Stickingonpunch facesDrythegranulesproperlyorincreaselubrication.

    2. Toodrygranules.Moistenthegranulestoplasticize. Addhygroscopicsubstances.

    3.Toomuchbindingcauseschippingatbottom.

    Optimizebinding,orusedrybinders.

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    TABLE.32. THECAUSES AND REMEDIESOF CHIPPING RELATED TOMACHINE(DIES,PUNCHES AND TABLET PRESS)

    Sr.No.

    CAUSES REMEDIES

    1.Grooveofdiewornatcompressionpoint.

    Polishtoopenend,reverseorreplacethedie.

    2.Barreleddie(centerofthediewiderthanends)

    Polishthedietomakeitcylindrical

    3.Edgeofpunch faceturnedinside/inward.

    Polishthepunchedges

    4.Concavitytoodeeptocompressproperly.

    Reduceconcavityofpunch faces.Use flatpunches.

    Cracking

    (1)

    Definition:Small, finecracksobservedontheupperandlowercentralsurfaceoftablets,or veryrarelyonthesidewallarereferredtoas Cracks.

    Reason:Itisobservedasaresultofrapidexpansionoftablets,especiallywhendeepconcavepunchesareused.

    TABLE.33. THECAUSES AND REMEDIESOF CRACKING RELATED TO FORMULATION

    (GRANULATION)

    Sr. No.CAUSESREMEDIES

    1. Largesizeofgranules. Reducegranulesize. Add fines.

    2. Toodrygranules.Moistenthegranulesproperlyandaddproper

    amountofbinder.

    3. Tabletsexpand. Improvegranulation. Adddrybinders.

    4. Granulationtoocold. Compressatroomtemperature.

    TABLE.34. THECAUSES AND REMEDIESOF CRACKING RELATED TOMACHINE(DIES,PUNCHES AND TABLET PRESS)

    Sr. No.CAUSES REMEDIES

    1. Tabletexpandsonejectionduetoairentrapment.Usetapereddie.

    2. Deepconcavitiescausecrackingwhile Usespecialtake-off.

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    removingtablets

    Sticking / Filming

    (1)

    Definition: Stickingreferstothetabletmaterialadheringtothediewall.

    Filmingisaslow formofstickingandislargelyduetoexcessmoistureinthegranulation.

    Reason:Improperlydriedorimproperlylubricatedgranules.

    TABLE.35. THECAUSES AND REMEDIESOF STICKING RELATED TO FORMULATION

    (GRANULATION)

    Sr.No.

    CAUSES REMEDIES

    1.Granulesnotdried

    properly.

    Drythegranulesproperly.Makemoistureanalysisto

    determinelimits.

    2.Toolittleorimproper

    lubrication.Increaseorchangelubricant.

    3. ToomuchbinderReducetheamountofbinderoruseadifferenttypeof

    binder.

    4.Hygroscopicgranular

    material.Modifygranulationandcompressundercontrolled

    humidity.

    5. Oilyorwaymaterials Modifymixingprocess. Addanabsorbent.

    6. Toosoftorweakgranules.Optimizetheamountofbinderandgranulationtechnique.

    TABLE.36. THECAUSES AND REMEDIESOF STICKING RELATED TOMACHINE(DIES,

    PUNCHES AND TABLET PRESS)

    Sr. No.CAUSES REMEDIES

    1. Concavitytoodeep forgranulation. Reduceconcavitytooptimum.

    2. Toolittlepressure. Increasepressure.

    3. Compressingtoo fast. Reducespeed.

    Picking

    (1)

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    Definition: Pickingisthetermusedwhenasmallamountofmaterial fromatabletisstickingtoandbeingremovedoff fromthetablet-surfacebyapunch face.

    Theproblemismoreprevalentontheupperpunch facesthanonthelowerones. The

    problemworsens,iftabletsarerepeatedlymanufacturedinthisstationoftoolingbecauseof

    themoreandmorematerialgettingaddedtothealreadystuckmaterialonthepunch face.

    Reason:Pickingisofparticularconcernwhenpunchtipshaveengravingorembossingletters,aswellasthegranularmaterialisimproperlydried.

    TABLE.37. THECAUSES AND REMEDIESOF PICKING RELATED TO FORMULATION

    (GRANULATION)

    Sr.No.

    CAUSES REMEDIES

    1. Excessivemoistureingranules.Dryproperlythegranules,determine

    optimumlimit.

    2. Toolittleorimproperlubrication.

    Increaselubrication;usecolloidalsilicaasa

    polishingagent,sothatmaterialdoesnot

    clingtopunch faces.

    3.

    Lowmeltingpointsubstances,may

    soften fromtheheatofcompressionandleadtopicking.

    Addhighmelting-pointmaterials.Usehigh

    metingpointlubricants.

    4.Lowmeltingpointmedicamentinhighconcentration.

    Refrigerategranulesandtheentiretabletpress.

    5. Toowarmgranuleswhencompressing.Compressatroomtemperature.Coolsufficientlybeforecompression.

    6. Toomuchamountofbinder.

    Reducetheamountofbinder,changethe

    typeorusedrybinders.

    TABLE.38. THECAUSES AND REMEDIESOF PICKING RELATED TOMACHINE(DIES,PUNCHES AND TABLET PRESS)

    Sr.No.

    CAUSES REMEDIES

    1. Roughorscratchedpunch faces. Polish facestohighluster.

    2.Embossingorengravinglettersonpunch facessuchasB, A,O, R,P, Q,G.

    Designletteringaslargeaspossible.

    Platethepunch faceswithchromiumtoproduceasmoothandnon-adherent face.

    3. Bevelsordividinglinestoodeep. Reducedepthsandsharpness.

    4.Pressureappliedisnotenough;toosoft

    tablets.Increasepressuretooptimum.

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    Binding

    (1)

    Definition: Bindinginthedie,isthetermusedwhenthetabletsadhere,seizeortearinthedie. A filmis formedinthedieandejectionoftabletishindered.Withexcessivebinding,thetabletsidesarecrackedanditmaycrumbleapart.

    Reason:Bindingisusuallyduetoexcessiveamountofmoistureingranules,lackoflubricationand/oruseofworndies.

    TABLE.39. THECAUSES AND REMEDIESOF BINDING RELATED TO FORMULATION

    (GRANULATION)

    Sr.No.

    CAUSES REMEDIES

    1.Toomoistgranulesandextrudes

    aroundlowerpunch.Drythegranulesproperly.

    2. Insufficientorimproperlubricant.

    Increasetheamountoflubricantoruseamore

    effectivelubricant.

    3. Toocoarsegranules.Reducegranularsize,addmore fines,and

    increasethe quantityoflubricant.

    4.Toohardgranules forthelubricant

    tobeeffective.Modifygranulation. Reducegranularsize.

    5.Granularmaterial veryabrasiveandcuttingintodies.

    Ifcoarsegranules,reduceitssize.

    Usewear-resistantdies.

    6.Granularmaterialtoowarm,sticks

    tothedie.

    Reducetemperature.

    Increaseclearanceifitisextruding.

    TABLE.40. THECAUSES AND REMEDIESOF BINDING RELATED TOMACHINE(DIES,

    PUNCHES AND TABLET PRESS)

    Sr.No.

    CAUSES REMEDIES

    1. Poorly finisheddies. Polishthediesproperly.

    2.Roughdiesduetoabrasion,

    corrosion.

    Investigateothersteelsorothermaterialsor

    modifygranulation.

    3. Undersizeddies. Toolittleclearance.

    Reworktopropersize.Increaseclearance.

    4.Toomuchpressureinthetablet

    press.

    Reducepressure.OR

    Modifygranulation.

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    Mottling

    (1)

    Definition: Mottlingisthetermusedtodescribeanunequaldistributionofcolouronatablet,withlightordarkspotsstandingoutinanotherwiseuniformsurface.

    Reason:Onecauseofmottlingmaybeacoloureddrug,whosecolourdiffers fromthecolourofexcipientsused forgranulationofatablet.

    TABLE.41. THECAUSES AND REMEDIESOF MOTTLING

    Sr.No.

    CAUSES REMEDIES

    1.

    A coloureddrugusedalong

    withcolourlessorwhite-

    colouredexcipients.

    Useappropriatecolourants.

    2.A dyemigratestothesurface

    ofgranulationwhiledrying.

    Changethesolventsystem,

    Changethebinder,

    Reducedryingtemperatureand

    Useasmallerparticlesize.

    3.Improperlymixeddye,

    especiallyduring Direct

    Compression.

    Mixproperlyandreducesizeifitisofalargersizetopreventsegregation.

    4.Impropermixingofacolouredbindersolution.

    Incorporatedrycolouradditiveduringpowderblending

    step,thenadd finepowderedadhesivessuchasacaciaandtragacanthandmixwelland finallyaddgranulating

    liquid.

    Double impression

    (1)

    Definition: DoubleImpressioninvolvesonlythosepunches,whichhaveamonogramorotherengravingonthem.

    Reason: Atthemomentofcompression,thetabletreceivestheimprintofthepunch.Now,onsomemachines,thelowerpunch freelydropsandtravelsuncontrolled forashortdistancebeforeridinguptheejectioncamtopushthetabletoutofthedie,nowduringthis

    freetravel,thepunchrotatesandatthispoint,thepunchmaymakeanewimpressiononthebottomofthetablet,resultingin DoubleImpression.

    Iftheupperpunchisuncontrolled,itcanrotateduringtheshorttraveltothe final

    compressionstageandcreateadoubleimpression.

    TABLE.42. THECAUSES AND REMEDIESOF DOUBLEIMPRESSION

    Sr.No.

    CAUSE REMEDIES

    1. Freerotationofeitherupper -Usekeyingintooling,i.e.insetakeyalongsideof

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    punchorlowerpunchduringejectionofatablet.

    the punch,sothatit fitsthepunchandpreventspunchrotation.

    -Newerpresseshaveanti-turningdevices,whichpreventpunchrotation.

    Problems and remedies for tablet coating

    Blistering

    (1,64)

    Definition:Itislocaldetachmentof film fromthesubstrate formingblister.

    Reason:Entrapmentofgasesinorunderneaththe filmduetooverheatingeitherduringsprayingorattheendofthecoatingrun.

    TABLE.43. THECAUSE AND REMEDYOF BLISTERING

    Sr.No.

    CAUSE REMEDY

    1.Effectoftemperatureonthestrength,elasticityand

    adhesionofthe film.Usemilddrying

    condition.

    Chipping

    (1,64)

    Definition:Itisdefectwherethe filmbecomeschippedanddented,usuallyattheedgesofthetablet.

    Reason:Decreasein fluidizingairorspeedofrotationofthedruminpancoating.

    TABLE.44. THECAUSE AND REMEDYOF CHIPPING

    Sr.No.

    CAUSE REMEDY

    1.

    Highdegreeofattritionassociatedwiththecoatingprocess. Increasehardnessofthe filmbyincreasingthe

    molecularweightgradeofpolymer.

    Cratering

    (1,64)

    Definition:Itisdefectof filmcoatingwhereby volcanic-likecratersappearsexposingthetabletsurface.

    Reason: Thecoatingsolutionpenetratesthesurfaceofthetablet,oftenatthecrownwherethesurfaceismoreporous,causinglocalizeddisintegrationofthecoreanddisruptionofthe

    coating.

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    TABLE.45. THECAUSES AND REMEDIESOF CRATERING

    Sr.No.

    CAUSES REMEDIES

    1.Inefficientdrying.

    Useefficientandoptimumdryingconditions.

    2.Higherrateofapplicationofcoatingsolution.

    Increase viscosityofcoatingsolutiontodecreasesprayapplicationrate.

    Picking

    (1,64)

    Definition:Itisdefectwhereisolatedareasof filmarepulledaway fromthesurfacewhenthetabletstickstogetherandthenpart.

    Reason:Conditionssimilartocrateringthatproducesanoverlywettabletbedwhereadjacenttabletscansticktogetherandthenbreakapart.

    TABLE.46. THECAUSES AND REMEDIESOF PICKING

    Sr.

    No.CAUSE REMEDY

    1. Inefficientdrying.Useoptimumandefficientdryingconditionsorincrease

    theinletairtemperature.

    2.Higherrateofapplicationof

    coatingsolution

    Decreasetheraterofapplicationofcoatingsolutionby

    increasing viscosityofcoatingsolution.

    Pitting

    (1,64)

    Definition:Itisdefectwherebypitsoccurinthesurfaceofatabletcorewithoutany visibledisruptionofthe filmcoating.

    Reason: Temperatureofthetabletcoreisgreaterthanthemeltingpointofthematerials

    usedinthetablet formulation.TABLE.47. THECAUSE AND REMEDYOF PITTING

    Sr.No.

    CAUSE REMEDY

    1. Inappropriatedrying Dispensingwithpreheatingproceduresattheinitiationof

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    (inletair)temperature

    coatingandmodifyingthedrying(inletair)temperaturesuchthatthetemperatureofthetabletcoreisnotgreaterthanthe

    meltingpointofthebatchofadditivesused.

    Blooming

    (1,64)

    Definition:Itisdefectwherecoatingbecomesdullimmediatelyorafterprolongedstorageathightemperatures.

    Reason:Itisduetocollectiononthesurfaceoflowmolecularweightingredientsincludedinthecoating formulation.Inmostcircumstancestheingredientwillbeplasticizer.

    TABLE.48. THECAUSE AND REMEDYOF BLOOMING

    Sr.No.

    CAUSE REMEDY

    1.

    Highconcentrationandlow

    molecularweightofplasticizer. Decreaseplasticizerconcentrationandincreasemolecularweightofplasticizer.

    Blushing

    (1,64)

    Definition:Itisdefectbestdescribedaswhitishspecksorhazinessinthe film.

    Reason:Itisthoughttobeduetoprecipitatedpolymerexacerbatedbytheuseofhighcoatingtemperatureatorabovethethermalgelationtemperatureofthepolymers.

    TABLE.49. THECAUSES AND REMEDIESOF BLUSHING

    Sr.No.

    CAUSES REMEDIES

    1. HighcoatingtemperatureDecreasethedryingairtemperature

    2.

    Useofsorbitolin formulationwhichcauseslargestfallinthethermalgelationtemperatureofthe

    HydroxyPropylCellulose, HydroxyPropylMethyl

    Cellulose,MethylCelluloseandCelluloseethers.

    Avoiduseofsorbitolwith HydroxyPropylCellulose, HydroxyPropyl

    MethylCellulose,MethylCellulose

    andCelluloseethers.

    Colour variation

    (1,64)

    Definition: A defectwhichinvolves variationincolourofthe film.

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    Reason: Alterationofthe frequencyanddurationofappearanceoftabletsinthesprayzoneorthesize/shapeofthesprayzone.

    TABLE.50. THECAUSE AND REMEDYOF COLOUR VARIATION

    Sr.No.

    CAUSE REMEDY

    1.

    Impropermixing,unevenspraypattern,insufficientcoating,migrationofsoluble

    dyes-plasticizersandotheradditivesduringdrying.

    Go forgeometricmixing,reformulation

    withdifferentplasticizersandadditivesorusemilddryingconditions.

    Infilling

    (1,64)

    Definition:Itisdefectthatrenderstheintagliationsindistinctness.

    Reason:Inabilityof foam, formedbyairsprayingofapolymersolution,tobreak. The foam

    dropletsonthesurfaceofthetabletbreakdownreadilyduetoattritionbuttheintagliationsformaprotectedareaallowingthe foamtoaccumulateand set.Oncethe foamhas

    accumulatedtoalevelapproachingtheoutercontourofthetabletsurface,normalattritioncanoccurallowingthestructuretobecoveredwithacontinuous film.

    TABLE.51. THECAUSE AND REMEDYOF INFILLING

    Sr.No.

    CAUSE REMEDY

    1.Bubbleor foam formationbecauseofairsprayingofapolymersolution

    Addalcoholorusespraynozzlecapableof fineratomization.

    Orange peel/Roughness

    (1,64)

    Definition:Itissurfacedefectresultinginthe filmbeingroughandnonglossy. Appearanceissimilartothatofanorange.

    Reason:Inadequatespreadingofthecoatingsolutionbeforedrying.

    TABLE.52. THECAUSES AND REMEDIESOF ORANGEPEEL/ROUGHNESS

    Sr. No.CAUSES REMEDIES

    1. RapidDrying Usemilddryingconditions

    2. Highsolution viscosityUseadditionalsolventstodecrease viscosityofsolution.

    Cracking/Splitting

    (1,64)

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    Definition:Itisdefectinwhichthe filmeithercracksacrossthecrownofthetablet(cracking)orsplitsaroundtheedgesofthetablet(Splitting)

    Reason:Internalstressinthe filmexceedstensilestrengthofthe film.

    TABLE.53. THECAUSE AND REMEDYOF CRACKING/SPLITTING

    Sr. No.CAUSE REMEDY

    1.Useofhighermolecularweight

    polymersorpolymericblends.

    Uselowermolecularweightpolymersorpolymeric

    blends. Alsoadjustplasticizertypeandconcentration.

    Key Phrases

    y Duringtabletmanufacture,anindustrialpharmacistusuallyencountersmanyproblems.Solvingtheseproblemsrequiresanin-depth

    knowledgeoftablet-formulationaswellasmachine-operating

    processes.

    y CappingandLaminationarethedefectsarisingasaresultofair-entrapmentinthegranularmaterial.

    y Chippingisadefectrelatedarisingdueto verydrygranules.y Crackingisduetorapidexpansionoftablets,whendeepconcave

    punchesareused.

    y Sticking,PickingandBindingaretheimperfectionsrelatedtomoreamountofbinderingranules.

    y Mottlingisanimperfectionarisingduetomorethanone factor:acoloureddrug,dirtingranulesortheuseofanoilylubricant.

    y Double-Impressionisrelatedtoamachinedefect:itiscausedbythefreerotationofpunchesthathavesomeengravingonthepunch-faces.

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    Coating defects:

    y Blisteringisrelatedtoentrapmentofgasesinorunderneaththe filmduetooverheatingeitherduringsprayingorattheendofthecoating

    run.Useofmilddryingconditionscansolvethisproblem.

    y Chippingisrelatedtohigherdegreeofattritionassociatedwiththecoatingprocess.Increaseinhardnessofthe filmbyincreasingthe

    molecularweightgradeofpolymercansolvethisproblem.

    y Crateringisrelatedtopenetrationofthecoatingsolutionintothesurfaceofthetablet,oftenatthecrownwherethesurfaceismore

    porous,causinglocalizeddisintegrationofthecoreanddisruptionof

    thecoating.Decreaseinsprayapplicationrateanduseofoptimum

    andefficientdryingconditionscansolvethisproblem.

    y Pittingisdefectinwhichtemperatureofthetabletcoreisgreaterthanthemeltingpointofthematerialsusedintablet formulation.

    Dispensingwithpreheatingproceduresattheinitiationofcoatingand

    modifyingthedrying(inletair)temperaturecansolvethisproblem.

    y Bloomingordull filmisgenerallybecauseofhigherconcentrationandlowermolecularweightofplasticizer.Souselowerconcentrationand

    highermoleculargradeofplasticizer.

    y Blushing/Whitishspecks/Hazinessofthe filmisrelatedtoprecipitationofpolymerexacerbatedbytheuseofhighcoatingtemperatureator

    abovethethermalgelationtemperatureofthepolymers.

    y Colour variationisbecauseofimpropermixing,unevenspraypattern,insufficientcoatingormigrationofsolubledyesduringdrying.

    Geometricmixing,milddryingconditionsandreformulationwith

    differentplasticizerscansolvethisproblem.

    y Infillingisbecauseofbubble/foam formationduringairsprayingofapolymersolution. Additionofalcoholoruseofspraynozzlecapableof

    fineratomizationcansolvethisproblem.

    y Orangepeel/Roughnessisrelatedtoinadequatespreadingofthecoatingsolutionbeforedrying.Sodecreasein viscosityofcoating

    solutioncancounterthisdefect.

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