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P h a r mace u t i cal Pa cka g i n g

P h a r mace u t i cal Pa cka g i n g. Dr. J. Domenech. Contents. I n t rodu c t i on T y pes of pa c k ag i ng s y s t e m s Cr i t er i a f or t he s e l e c t i on of pa c k age t y pe and pa c k age m a t er i al P a c k ag i ng e v a l ua t i on

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P h a r mace u t i cal Pa cka g i n g

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  1. PharmaceuticalPackaging Dr. J. Domenech

  2. Contents • Introduction • Typesofpackagingsystems • Criteriafortheselectionofpackagetypeandpackagematerial • Packagingevaluation • Dosageformsandpackageforms • Containers:Glass,Plastic,Metal • Paperandboard • Films,foilsandlaminates • Rubbercomponents • Cotton • AdhesivesandInks • Closures • Specialtypeofdeliverydevices:Aerosols,Transdermals • PackagingofMedical/SurgicalDevices • EconomicAspects • StudyQuestions • References

  3. Introduction • DEFINITION: • Packing:“Packing consists ofenclosing an individualitem,orseveralitems,in a container,usuallyforshipmentor delivery.This operation is mostly done by hand and machine.” • Pharmaceutical Packaging:“Pharmaceutical packaging means the combination ofcomponents necessary to contain,preserve,protect&deliver a safe,efficaciousdrug product,such thatatany time pointbeforeexpirationdateofthedrugproduct,asafe&efficaciousdosage formis available.

  4. Types ofPackaging Systems • Primarypackagesystem:Made upofthosepackagecomponents • &subcomponentsthatcomeinto directcontactwiththeproduct,or thosethatmayhaveadirecteffect ontheproductshelflife. corrugatedshippers&pallets.

  5. IdealRequirementsofPharmaceuticalPackagingMaterials

  6. PossibleInteractionsBetween PrimaryPackaging Materialsand theIncludedPharmaceutical Product

  7. PackagingEvaluation

  8. Dosage FormsAnd PackageForms DOSAGE FORM ROUTEOF DELIVERY POSSIBLEPACKAGE FORM CONDITION Glass/plasticBottleWithCap Blister&Strip Pack Solids (Tablets,Capsules, Non-Sterile Oral Sachet/Pouches/Drums/Jars Powders) Solids (Suppository) Foil/Pouch orBlister Non-Sterile Rectal Solids Aseptic Inhalation Dry-PowderInhaler

  9. Glass/plasticBottleWithCap BottleWithSprayPumpBottleWithDropperSachet,PouchesDrumsand Jars Liquids Non-Sterile Oral Glass/plasticBottleWithCapCollapsible Tube AerosolSpraysDrumsand Jars GlassAmpoules Glass/PlasticVialWithStopper Glass/PlasticVialWithApplicatorPre-filledSyringe Bag Form-fill-sealPlastic Container Liquids Non- Topical Sterile Parenteral Ophthalmi- cs Liquids Sterile

  10. Collapsible TubePump(HighViscosity Dispenser) TransdermalDeliveryDeviceGlass/PlasticJar Ointments/Creams Non-Sterile Topical Collapsible Tube Glass/PlasticBottle WithCap Form-fill-sealPlasticBottleGlass/PlasticJar SoftGelatinCapsules Ointments Sterile Ophthalmic

  11. Packagingmaterials • Glass • Plastic • Metals:Aluminum,StainlessSteel • PaperandBoard • Rubber • Cotton • Closures

  12. Glass containers • Advantages • Disadvantages • Types

  13. Plasticcontainers • Commonlyusedpolymers: • PolyethylenePolypropylenePoly-vinyl-chloridePolystyrene • Lesscommonlyusedpolymers: • Poly-methyl-methacrylatePoly-ethylene-terephthalatePoly-trifluoro-ethyleneAmino-formaldehydesPolyamides

  14. Plasticcontainers • Advantages • Limitations/interactionsbetween plasticsanddosageform • PermeationLeachingSorption • Chemicalreactivity Modification

  15. Metalcontainers • Stainlesssteel • Aluminum

  16. PaperandBoard • Applications/Advantages

  17. Films,FoilsandLaminates • Materialsusedforfilmsandfoils • Metallization • UsesofFilms,FoilsandLaminates

  18. Rubberbasedcomponents

  19. ExamplesofRubberfor Pharmaceuticalproductpackaging • NaturalRubber • NeopreneRubber • NitrileRubber • ButylRubber • Chloro-butylRubber • Bromo-butylRubber • SiliconeRubber

  20. ComplexRubber • Vulcanizingagents • Accelerators • Fillers • Activators • Pigments • Anti-oxidants • Lubricants • Softeners(waxes)

  21. Cotton • Insolidpreparationsitisusedto preventcollisionofindividualunits • Asdesiccant:Toprevent absorptionofmoistureparticularly bysoliddosageformslike:tablets andcapsules.

  22. Adhesives andInks

  23. Closure • Idealcharacteristicsofaclosure • Functionsofaclosure

  24. Aerosols

  25. Transdermals

  26. PackagingofMedical/SurgicalDevices • RequirementsofpackagingmaterialsforMedical/SurgicalDevices

  27. EvaluationTestscarriedoutformedicaldevices • Sterilitytesting • Manualhandling • Vehiclestacking • Loose-loadvibration • Droptest • Compression • Packagesealstrengthtesting

  28. EconomicAspectsandOutlook • Investigatorshouldhaveabroad backgroundinvariousdisciplines • Newdosageforms,newmaterials, newdrugclasses

  29. Studyquestions • Define:PackingandPharmaceuticalPackaging • Whatare thecriteria fortheselectionofmaterialsforpharmaceuticalpackaging? • Givedetailsofglassasthepackaging material • Whatare thespecificcriteria forthepackagingofAerosols,Transdermalsand MedicalDevices?

  30. References DonaldC.Liebe,PackagingofPharmaceuticalDosageForm,ModernPharmaceuticsbyG.S.Banker,MarcelDekker,pp681-725. C.P.Croce,A.Fischer&R.L.Thomas,PackagingmaterialScience,The theory&PracticeofIndustrialPharmacybyLeonLachman,Third edition pp711-732 Autian.J.,J.Pharm.Sci.,52,1963,pp1,105 4. D.C.Liebe, Pharmaceutical Packaging, Encyclopedia of Marcel Dekker, New Pharmaceutical Technology, volume 12, York,1993,pp1-28 5. R.P.Abendroth, Glass as a packaging material for pharmaceuticals,Encyclopedia of Pharmaceutical Technology, volume 7, Marcel Dekker,NewYork,1993,pp79-99

  31. 6.S.W.Shalaby &B.L.Williams,packaging,Encyclopedia Films and sheets for of Pharmaceutical Technology,volume 6,Marcel Dekker,New York,1993,pp29-49 7.ElastomericclosuresforPharmaceuticalpackaging 8.USP24,NF19,2000.pg 10. 9.Plastic Packaging ,Remington: The Science andPracticeofPharmacy,19thedition,VolumeII,pp 1487. 10.M.E.Aulton,form design,725 Pharmaceutics :The science of dosage D.A.Dean- packaging technology,pp.712-

  32. 11.CooperandGunn’sTutorialPharmacy,sixthedition,pp. 133-141. 12.WHOTechnicalReportSeries,no.902,2002,Annex9,Guidelines on packaging for Pharmaceutical products,pp120-137. www.fda.gov\packaging.htm http://www.devicelink.com/pmpn/archive/98/08/002.html Packaging engineering by Louis C.Barail,ReinholdPublishing Corporation,U.S.A.,1994.Pages:1-11,357- 364.

  33. Medicaldevicepackaginghandbook,editedbyJosephD.O’Brien,1990,publishedbyMarcelDekkerInc.Pages:51-220.Medicaldevicepackaginghandbook,editedbyJosephD.O’Brien,1990,publishedbyMarcelDekkerInc.Pages:51-220. PackagingofPharmaceuticalsbyC.F.Ross,first edition1975,byNewnes–Butterworths;London.

  34. WWW.MYPHARMAGUIDE.COM

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