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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