Pharmacy Courses

Packaging and Stability of Pharmaceutical Products

Pharmaceutical packaging enables the packaged medicine’s requirements of efficacy, safety, uniformity, reproducibility, integrity, purity and stability to be maintained throughout the product’s shelf life. At the same time it provides identification and information, enabling patient compliance and convenience.

The wide range off pharmaceutical products, such as solid powders, granules, tablets, capsules, semisolids (e.g. creams, ointments, gels), liquids (such as solutions, suspensions, emulsions), some of which are sterile, obviously require a great diversity, both in primary pack design and in packaging materials.

The latter include paper, glass, plastics, rubber, metal or combination materials such as laminates. Examples of primary packs include blister packs, strip packs, sachets, bottles, ampoules, vials, bags, tubes and syringes. The primary pack may contain many doses (i.e. be a multiple-unit pack, e.g. a bottle containing many tablets) or a single dose (i.e. be a single-unit pack, e.g. blister pack, sachet).

The primary pack must offer child-resistance to restrict children’s access to the product. Child resistant packs have been successful in reducing accidental poisoning of children.

The primary pack must be compatible with the product, and take nothing out of the product and add nothing in. Drug absorption or adsorption into the pack would reduce product potency, while chemicals leaching out of the pack and into the product could induce drug degradation. In addition, the primary pack must protect the product against atmospheric actors, such as extremes of temperature, light, moisture, oxygen, carbon dioxide, particulates (e.g. dust, dirt), as well as biological hazards, such as microorganisms, insects and rodents, and enable product stability.

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