Drug packaging materials

Jenkins, W.A. Osburn, K.R. Packaging drugs and pharmaceuticals, drug packaging materials.. In Cooperation with Institute of Packaging Professionals, Technomic Publishing Co. Lancaster, PA, 1993 99-102. 

Jenkins, W.A. Osborn, K.R. Drug packaging materials. In Packaging Drugs and Pharmaceuticals, Technomic Publishing Company Lancaster, 1993 99-142. 

Since full analyses are carried out, a lot of data are generated. Every parameter is reviewed for trends that signal product aging or outright decomposition of the active principle this can be as cosmetic in nature as discoloration or as potentially hazardous as buildup of toxic derivatives. If the drug substance is an ester, for example, hydrolysis, particularly if moisture penetrates the primary packaging material, will decompose the compound into its acid and alcohol components. From a pharmaceutical or medical viewpoint, even if there is no toxicity issue involved, this will result in a loss of bioavailability. Even this is to be avoided because subpotency introduces therapeutic uncertainty and can go as far as lethal undertreatment. 

There shall be written procedures designed to assure that correct labels, labeling, and packaging materials are used for drug products such written procedures shall be followed. These procedures shall incorporate the following features ... 

A description of the drug product containers, closures, and packaging materials, including a specimen or copy of each label and all other labeling signed and dated by the person or persons responsible for approval of such labeling ... 

The definition of a food additive in Section 201(s) of the Federal Food, Drug, and Cosmetic Act, as amended ( the Act ) refers to substances whose intended use results directly or indirectly in the substance becoming a component of food. The FDA refers to direct food additives as those added to a food to accomplish an intended effect. Indirect additives are those that unintentionally, though predictably, become components of food. Components of plastic packaging materials that can migrate to food are indirect additives. 

Phenol is listed on the Food and Drug Administration s EAFUS (Everything Added to Foods in the United States) List (FDA 1998a), and is approved as a component of food packaging materials (FDA 1998b, 1998c, 1998d). 

Chemical breakdown of the drug resulting from its reaction with air, water, light, excipients in a formulation or with packaging materials... 

The cGMP regulations assign specific duties to the quality control unit. The unit is required to have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material,... 

Extractability tests prescribed by other regulatory agencies [FDA, Parenteral Drug Association (PDA)] for closures for drug packaging [69,70] are also limited to the amount of extractable residues or tests to evaluate the in vivo reaction of the extractable residue when the material fails in the in vitro tests. 

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