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Pharmaceutical Packaging
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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
Introduction
DEFINITION:� Packing: “Packing consists of enclosing an individualitem, or several items, in a container, usually for shipmentor delivery. This operation is mostly done by hand andor delivery. This operation is mostly done by hand andmachine.”
� Pharmaceutical Packaging: “Pharmaceutical packagingmeans the combination of components necessary tocontain, preserve, protect & deliver a safe, efficaciousdrug product, such that at any time point beforeexpiration date of the drug product, a safe & efficaciousdosage form is available.
Types of Packaging Systems
� Primary package system: Madeup of those package components& subcomponents that come intodirect contact with the product, ordirect contact with the product, orthose that may have a direct effecton the product shelf life.
� Secondary or tertiary packagesystem: Includes cartons,corrugated shippers & pallets.
Ideal Requirements of Pharmaceutical Packaging MaterialsMaterials
Possible Interactions Between Possible Interactions Between Primary Packaging Materials and Primary Packaging Materials and the Included Pharmaceutical the Included Pharmaceutical Primary Packaging Materials and Primary Packaging Materials and the Included Pharmaceutical the Included Pharmaceutical ProductProduct
Packaging EvaluationPackaging EvaluationPackaging EvaluationPackaging Evaluation
Dosage Forms And Package FormsDosage Forms And Package Forms
DOSAGE
FORM CONDITION ROUTE OF
DELIVERY
POSSIBLE PACKAGE
FORM
Solids
(Tablets,
Capsules, Non-Sterile Oral
Glass/plastic Bottle
With Cap
Blister & Strip PackCapsules,
Powders)
Non-Sterile Oral Blister & Strip Pack
Sachet/ Pouches/
Drums/ Jars
Solids
(Suppository)Non-Sterile Rectal Foil / Pouch or Blister
Solids Aseptic Inhalation Dry- Powder Inhaler
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
Sterile 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
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
Packaging materialsPackaging materials
� Glass
� Plastic
� Metals: Aluminum, Stainless Steel� Metals: Aluminum, Stainless Steel
� Paper and Board
� Rubber
� Cotton
� Closures
Glass containers
� Advantages
� Disadvantages� Disadvantages
� Types
Plastic containers
� Commonly used polymers:
Polyethylene
Polypropylene
Poly-vinyl-chloride
PolystyrenePolystyrene
� Less commonly used polymers:
Poly-methyl-methacrylate
Poly-ethylene-terephthalate
Poly-trifluoro-ethylene
Amino-formaldehydes
Polyamides
Plastic containers
� Advantages
� Limitations / interactions between plastics and dosage formplastics and dosage form
Permeation
Leaching
Sorption
Chemical reactivity
Modification
Metal containers
� Stainless steel
� Aluminum
Paper and Board
� Applications / Advantages
Films, Foils and Laminates
� Materials used for films and foils
� Metallization � Metallization
� Uses of Films, Foils and Laminates
Rubber based components
Examples of Rubber for Pharmaceutical product packaging
� Natural Rubber
� Neoprene Rubber
� Nitrile Rubber � Nitrile Rubber
� Butyl Rubber
� Chloro-butyl Rubber
� Bromo-butyl Rubber
� Silicone Rubber
Complex Rubber
� Vulcanizing agents
� Accelerators
� Fillers� Fillers
� Activators
� Pigments
� Anti-oxidants
� Lubricants
� Softeners (waxes)
Cotton
� In solid preparations it is used to
prevent collision of individual units
� As desiccant: To prevent
absorption of moisture particularly absorption of moisture particularly
by solid dosage forms like: tablets
and capsules.
Adhesives and Inks
Closure
� Ideal characteristics of a closure
� Functions of a closure
Aerosols
Transdermals
Packaging of Medical / Surgical Devices
� Requirements of packaging � Requirements of packaging
materials for Medical / Surgical
Devices
Evaluation Tests carried out for medical devices
� Sterility testing
� Manual handling
� Vehicle stacking� Vehicle stacking
� Loose-load vibration
� Drop test
� Compression
� Package seal strength testing
Economic Aspects and Outlook
� Investigator should have a broad
background in various disciplines
� New dosage forms, new materials,
new drug classes
Study questions
� Define: Packing and Pharmaceutical
Packaging
� What are the criteria for the selection of
materials for pharmaceutical packaging?materials for pharmaceutical packaging?
� Give details of glass as the packaging
material
� What are the specific criteria for the
packaging of Aerosols, Transdermals
and Medical Devices?
References
1. Donald C. Liebe, Packaging of Pharmaceutical Dosage Form, ModernPharmaceutics by G.S.Banker, Marcel Dekker, pp 681-725.
2. C.P.Croce, A.Fischer & R.L.Thomas, Packaging material Science, Thetheory & Practice of Industrial Pharmacy by Leon Lachman, Thirdedition, pp 711-732edition, pp 711-732
3. Autian. J., J.Pharm.Sci. , 52, 1963, pp 1, 105
4. D.C.Liebe, Pharmaceutical Packaging, Encyclopedia ofPharmaceutical Technology, volume 12, Marcel Dekker, NewYork,1993, pp 1-28
5. R.P.Abendroth, Glass as a packaging material for pharmaceuticals,Encyclopedia of Pharmaceutical Technology, volume 7, MarcelDekker, New York, 1993, pp 79-99
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 24, NF 19, 2000. pg 10.8. USP 24, NF 19, 2000. pg 10.
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
11. Cooper and Gunn’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.fda.gov\packaging.htm13. www.fda.gov\packaging.htm
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.
16. Medical device packaging 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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