packaging technologies of pharmaceutical products

Packaging of pharmaceutical products

1. Packaging of Pharmaceutical Products

2. DEFENITION Packaging can be defined as an economical means of providing presentation, protection,identification /information, containment, convenience and compliance for a product during storage, carriage, display and use until such time as the product is used or administered.

3. The material selected must have the following characteristics: They must protect the preparation from environmental conditions They must not be reactive with the product They must not impart to the product tastes or odors They must be non toxic They must be approved (e.g. by FDA) They must meet applicable tamper resistance requirements They must be adaptable to commonly employed high speed packaging equipment

4. Recently there has been a distinct move from oral liquids to the solid dose form which has more recently concentrated on delayed or sustained release products. Such changes have influence on the type of pack used as shown by the increasing applications of blister and strip packaging . The role of the pack

5. The role of the pack The shelf life of the pharmaceutical products is largely dependent on certain functions of the pack. The pack must be: economical it must provide protection against climatic, biological, physical and chemical hazards it must provide an acceptable presentation which will contribute to or enhance product confidence maintaining adequate identification and information must contribute in terms of convenience and compliance

6. Mechanical hazards Shock or impact damage Vibration Abrasion puncture

7. Climatic or environmental hazards Moisture Temperature Pressure Light Atmospheric gases

8. Ingredients hazard Biological hazards Chemical hazards

9. Factors influencing choice of pack The product The market The distribution system Manufacturing facilities

10. Glass Containers Glass is commonly used in pharmaceutical packaging because it possess: Superior protective qualities It is economical Containers are readily available in variety of sizes and shapes It is chemically inert Impermeable Strong and rigid It has FDA clearance It does not deteriorate with age With a proper closure system it provides an excellent barrier against every element except light Colured glass especially amber, can give protection against light when it is required The major disadvantage of glass as a packaging material are its fragility and weight

11. Plastic Containers Plastics in packaging have proved useful for a number of reasons, including the ease with which they can be formed, and their high quality. Plastic containers are extremely resistant to breakage and thus offer safety to consumers along with reduction of breakage losses Plastic containers for pharmaceutical products are primarily made from the following polymers: polyethylene, polypropylene, polyvinylchloride, polystyrene, and to a lesser extent polymethyl methacrylate , polyethylene terephthalate , polytrifluoroethylene , the amino formaldehydes, and polyamides

12. Plastic Containers……………….. Plastic containers consist of one or more polymers together with certain additives. Those manufactured for pharmaceutical purposes must be free of substances that can be extracted in a significant quantities by the product contained therein. For plastic containers in general additives may consists of antioxidants, antistatic agents, colours , lubricants, plasticizers, and stabilizers

13. Materials A great number of plastic resins are available for the packaging of drug products. The most popular ones are: polyethylene, polyvinylchloride, polypropylene, polystyrene, nylon (polyamide), polycarbonate, acrylic multipolymers , polyethylene terephthalate (PET)

14. Drug plastic considerations A packaging system must protect the drug without in any way altering the composition of the product until the last dose is removed Drug plastic considerations have been divided into five separate categories Permeation Leaching Sorption Chemical reaction Alteration in the physical properties of plastics or products

15. Film Wrapper Film wrapping has been used extensively over the years for products requiring package integrity or environmental protection. Film wrapping is classified into the following types: End-folded wrapper Fin seal wrapper Shrink wrapper

16. End-folded wrapper The end-folded wrapper is formed by pushing the product into a sheet of overwrapping film which forms the film around the product and folds the edges in a gift-wrap fashion. The folded areas are sealed by pressing against a heated bar. The film used must be heat sealable on both surfaces. Materials commonly used for this application are cellophane.

17. End-folded wrapper

18. fin seal wrapper The seals are formed by crimping the film together and sealing together the two inside surfaces of the film, producing a fin seal

19. Fin seal wrapper

20. Shrink wrapper Film overwrapping can also be accomplished with the use of shrink wrapper. The shrink wrap concept involves the packaging of a product in a thermoplastic film that has been stretched and oriented during its manufacture and that has the property of reverting back to unstretched dimensions once the molecular structured is unfrozen by the application of heat.

21. Shrink wrapper

22. Blister package

23. Strip Package