Tablet manufacturing process - Glocal University

1 tablets manufacturing ShmmonAhmad, Asst. Professor, (Faculty of Pharmaceutics) GlocalUniversity, Saharanpur Former Officer Ind-Swift Ltd. (WHO, GMP, MHRA-UK, EME-Europe) INTRODUCTION2 , Tabletsformationprocessconsistofaserieso fsteps(unitprocesses) weighing,milling,mixing,granulation,dryi ng,compaction,(frequently) weighing,millingandmixing,arethesame; goals of Tablet manufacturingprocess3 Toformulatetabletsthatarestrongandhardto withstand mechanicalshockencounteredduringmanufact uring,packing,shipping, dispensing anduse. To formulate tablets that are uniform in weight and in drugcontent.

2 Toformulatetabletsthatarebioavailableacc ordingtoindicationrequirements. To formulate tablets that are chemically and physically stable over a long period oftime. Toformulatetabletsthathaveelegantproduct identitywhichisfreefrom any of tablets for oral use 1. uncoated tablets ; 2 coated tablets ; 3 gastro-resistant tablets ; 4. modified-release tablets ; 5. effervescent tablets ; 6. soluble tablets ; 7. dispersible tablets ;8. orodispersibletablets; 9. chewable tablets ; 10. oral of API & ExcipientSieving/screeningSize reductionBlending GranulationCompressionCoatingPackagingTa blets Dispatch in market 6 Processing of Granulation(tabletsGranules)Procedure for ManufacturingofTablets7 Sizing.

3 Formulationingredientsmustbeinfinelydivi dedform,otherwise, ,pneumatic tumblingmixersdiffusion/ mixers( ,V-blender,doubleconeblender, cubic mixer, drumblender), ,Rotatingshapegranulators,drygranulator, ,rotarydryer, , (QC) ,disintegrationequipment,USPD issolutionTester,TabletHardnessTester,Ta bletThicknessTester, ,standardcoatingpan,perforatedpan, ,blisterpackingmachine,aluminiumfoilpack agingmachine, manufacturing Equipment/Machines11 ,Hammermill,rollermill,fluidizedenergymi ll, ,bulkweighingbalance(weighsinkilogram),e lectronicweighingbalance(weighsingramsan dmilligrams).

4 PowdersuitableJSS College of Pharmacy,Mysuru12blending:Powders blendertoobtainaremixedusinga Granulation:Heresmallpowderparticlesareg atheredtogetherintolayers,andpermanentag gregatestorenderthemintofree-flowingstat es. Tabletcompression:Thisstepinvolvesthecom pressionofgranulesintoaflatorconvex,roun d,oblong,oruniqueshaped,scoredorunscored tablets ;engravedwithanidentifyingsymbola nd/orcodenumberusingtabletpress. Coating: used in tabletFormulation14 tablets are commonly manufacturedby Wetgranulation Dry granulationor Direct compression15 WETGRANULATION16 Thegranulesproducedusingthismethodofmeet ingallgranulationhasagreaterprobabilityo f ,millingandmixingoftheAPIswithpowderedex cipients(excludingthelubricant) (wetscreening)

5 Dry screening using 14-to of granules intotabletsDRYGRANULATION18 Theformationofgranulesbycompactingpowder mixturesintolargepiecesorcompactswhichar esubsequentlybrokendownorsizedintogranul es(oftenreferredtoasdry granulation,doublecompressionorpre-compr ession)isapossiblegranulationmethodwhich ,however, granulationmethodJSS College of Pharmacy,Mysuru19 WeighingandMillingofformulation ingredients (drug substance andexcipients) Mixing of milledpowders. Compression of mixed powders intoslugs. Milling and sieving ofslugs. Mixing with disintegrate andlubricant. Compression directcompressioninvolvesdirectcompressi onofpowderedmaterialsintotabletswithoutm odifyingthephysicalnatureofthematerialsi tself.

6 Directcompressionproblemsassociatedavoid s withmanyofthe are being formed by compressing the granules by using the compression formed in compression machine by pressing the granules in die with lower and upper punch. Tablet formation takes place by the combined pressing action of two punches (lower and upper) and a it is possible to produce more than 500,000 tablets per hour due to different sinnovations to Tablet compression compression Processing stepsEvaluation oftablets25 Officialtests Contentofactiveingredient/absolutedrug content test/ assay of activeingredient.

7 Weight uniformity test/ weight variationtest Friability Test Hardness Test Disintegration timetest Dissolutiontest26 tablets /QC test Equipment Weighing Balance Friability Tester Hardness Tester Disintegration timetester DissolutiontesterPercentage weight variation Limit for TabletsDisintegrationtestingconditionJSS College of Pharmacy,MysuruDisintegration testing condition and interpretation(IP)Sr. NoType oftabletsMediumTemperatureLimit1 UncoatedWater/buffer37 2 C15 min or as per individual monograph2 FilmcoatedWater37 2 C30 min or as perindividualmonograph3 HCl37 2 C60 min or as per individual monograph4 Dispersible TabletsWater25 1 C03 min or as per individual monograph5 Effervescent TabletsWater25 5 C05 min or as per individual monograph6 Enteric-coated M HCl mixed phosphate buffer 2 C02 hour in HCl: no disintegration 60 min in buffer.

8 Disintegrate7 SolubleTabletsWater20 5 C03 minutesJSS College of Pharmacy,MysuruDisintegrationtestingcond ition(USP)Sr. NoType of tabletsMediumTemperatureLimit1 UncoatedWater/asspecified inmonograph37 2 CAs per individualmonograph2 CoatedWater/asspecifiedinmonograph37 2 CAs per individualmonograph4 Enteric-coated TabletsSimulated gastric fluid TS Simulated intestinal fluidTS37 2 C01 hour in Simulated gastric fluid As per individual monograph: Simulated intestinal fluidTS5 BuccalTabletsWater/asspecified inmonograph37 2 C4hour6 Sublingual tabletsWater/asspecified inmonograph37 2 CAs per individualmonographPackaging and storing oftablets The DifferentTypesofTablet PackingMachines StripPackingMachine.

9 BlisterPackagingMachines. Aluminium foilpackagingmachine. LFA AutomaticTabletCounting Machine. Automatic PouchPackingMachine. Verticaltablet packingmachinery. EconomicalTablet PackagingEquipment. Fill & Sealing ,theyareusuallypackagedusing packaging31 Tablet Packaging Machine32