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Pharmaceutical packaging
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- 2. Contents Introduction Types of packaging systems Criteria for the selection of package type and package material Packaging evaluation Dosage forms and package forms Containers: Glass, Plastic, Metal Paper and board Films, foils and laminates Rubber components Cotton Adhesives and Inks Closures Special type of delivery devices: Aerosols, Transdermals Packaging of Medical / Surgical Devices Economic Aspects Study Questions References
- 3. Introduction DEFINITION: Packing: “Packing consists of enclosing an individual item, or several items, in a container, usually for shipment or delivery. This operation iiss mmoossttllyy ddoonnee bbyy hhaanndd aanndd machine.” Pharmaceutical Packaging: “Pharmaceutical packaging means the combination of components necessary to contain, preserve, protect deliver a safe, efficacious drug product, such that at any time point before expiration date of the drug product, a safe efficacious dosage form is available.
- 4. Types of Packaging Systems Primary package system: Made up of those package components subcomponents that come into direct contact wwiitthh tthhee pprroodduucctt,, oorr those that may have a direct effect on the product shelf life. Secondary or tertiary package system: Includes cartons, corrugated shippers pallets.
- 5. Ideal Requirements of Pharmaceutical Packaging MMaatteerriiaallss
- 6. Possible Interactions BBeettwweeeenn PPrriimmaarryy PPaacckkaaggiinngg MMaatteerriiaallss aanndd tthhee IInncclluuddeedd PPhhaarrmmaacceeuuttiiccaall PPrroodduucctt
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- 8. Dosage Forms AAnnddPPaacckkaaggee FFoorrmmss DOSAGE FORM CONDITION ROUTE OF DELIVERY POSSIBLE PACKAGE FORM Solids (Tablets, Capsules, Non-Sterile Oral Glass/plastic Bottle With Cap Blister Strip Pack Powders) Sachet/ Pouches/ Drums/ Jars Solids (Suppository) Non-Sterile Rectal Foil / Pouch or Blister Solids Aseptic Inhalation Dry- Powder Inhaler
- 9. Liquids Non- Sterile Oral Glass/plastic Bottle With Cap Bottle With Spray Pump Bottle With Dropper Sachet, Pouches Drums and Jars Liquids Non- Sterile Topical Glass/plastic Bottle With Cap Collapsible Tube Aerosol Sprays Drums and Jars Liquids Sterile Parenteral Ophthalmi-cs Glass Ampoules Glass / Plastic Vial With Stopper Glass / Plastic Vial With Applicator Pre-filled Syringe Bag Form-fill-seal Plastic Container
- 10. Ointments/ Creams Non- Sterile Topical Collapsible Tube Pump (High Viscosity Dispenser) Transdermal Delivery Device Glass / Plastic Jar Ointments Sterile Ophtha lmic Collapsible Tube Glass / Plastic Bottle With Cap Form-fill-seal Plastic Bottle Glass / Plastic Jar Soft Gelatin Capsules
- 11. PPaacckkaaggiinngg mmaatteerriiaallss Glass Plastic MMeettaallss:: AAlluummiinnuumm,, SSttaaiinnlleessss SStteeeell Paper and Board Rubber Cotton Closures
- 12. Glass containers Advantages DDiissaaddvvaannttaaggeess Types
- 13. Plastic containers Commonly used polymers: Polyethylene Polypropylene Poly-vinyl-chloride PPoollyyssttyyrreennee Less commonly used polymers: Poly-methyl-methacrylate Poly-ethylene-terephthalate Poly-trifluoro-ethylene Amino-formaldehydes Polyamides
- 14. Plastic containers Advantages Limitations / interactions between plastics aanndd ddoossaaggee ffoorrmm Permeation Leaching Sorption Chemical reactivity Modification
- 15. Metal containers Stainless steel Aluminum
- 16. Paper and Board Applications / Advantages
- 17. Films, Foils andLaminates Materials used for films and foils MMeettaalllliizzaattiioonn Uses of Films, Foils and Laminates
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- 19. Examples of Rubberfor Pharmaceutical product packaging Natural Rubber Neoprene Rubber NNiittrriillee RRuubbbbeerr Butyl Rubber Chloro-butyl Rubber Bromo-butyl Rubber Silicone Rubber
- 20. Complex Rubber Vulcanizing agents Accelerators FFiilllleerrss Activators Pigments Anti-oxidants Lubricants Softeners (waxes)
- 21. Cotton Insolid preparations it is used to prevent collision of individual units As desiccant: To prevent absorption of moisture ppaarrttiiccuullaarrllyy by solid dosage forms like: tablets and capsules.
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- 23. Closure Idealcharacteristics of a closure Functions of a closure
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- 26. Packaging of Medical/ Surgical Devices Requirements ooff ppaacckkaaggiinngg materials for Medical / Surgical Devices
- 27. Evaluation Tests carriedout for medical devices Sterility testing Manual handling VVeehhiiccllee ssttaacckkiinngg Loose-load vibration Drop test Compression Package seal strength testing
- 28. Economic Aspects andOutlook Investigator should have a broad background in various disciplines New dosage forms, new materials, new drug classes
- 29. Study questions Define: Packing and Pharmaceutical Packaging What are the criteria for the selection of materials for pharmaceutical ppaacckkaaggiinngg?? Give details of glass as the packaging material What are the specific criteria for the packaging of Aerosols, Transdermals and Medical Devices?
- 30. References 1. DonaldC. Liebe, Packaging of Pharmaceutical Dosage Form, Modern Pharmaceutics by G.S.Banker, Marcel Dekker, pp 681-725. 2. C.P.Croce, A.Fischer R.L.Thomas, Packaging material Science, The theory Practice of Industrial Pharmacy by Leon Lachman, Third eeddiittiioonn,, pppp 771111--773322 3. Autian. J., J.Pharm.Sci. , 52, 1963, pp 1, 105 4. D.C.Liebe, Pharmaceutical Packaging, Encyclopedia of Pharmaceutical Technology, volume 12, Marcel Dekker, New York,1993, pp 1-28 5. R.P.Abendroth, Glass as a packaging material for pharmaceuticals, Encyclopedia of Pharmaceutical Technology, volume 7, Marcel Dekker, New York, 1993, pp 79-99
- 31. 6. S.W.Shalaby B.L.Williams, Films and sheets for packaging, Encyclopedia of Pharmaceutical Technology, volume 6, Marcel Dekker, New York,1993, pp 29-49 7. Elastomeric closures for Pharmaceutical packaging 8. USP 2244,, NNFF 1199,, 22000000.. ppgg 1100.. 9. Plastic Packaging , Remington: The Science and Practice of Pharmacy, 19th edition, Volume II, pp 1487. 10. M.E.Aulton, Pharmaceutics : The science of dosage form design, D.A.Dean- packaging technology, pp. 712- 725
- 32. 11. Cooper andGunn’s Tutorial Pharmacy, sixth edition, pp. 133-141. 12. WHO Technical Report Series, no. 902, 2002, Annex 9, Guidelines on packaging for Pharmaceutical products, pp 120-137. 13. www.ffddaa..ggoovvppaacckkaaggiinngg..hhttmm 14. http://www.devicelink.com/pmpn/archive/98/08/002.html 15. Packaging engineering by Louis C. Barail, Reinhold Publishing Corporation, U.S.A., 1994. Pages: 1-11, 357- 364.
- 33. 16. Medical devicepackaging handbook, edited by Joseph D. O’Brien, 1990, published by Marcel Dekker Inc. Pages: 51-220. 17. Packaging of Pharmaceuticals by C. F. Ross, first edition 1975, by Newnes –Butterworths; London.
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