Drug packaging materials composition

Packaging materials must protect the dmg without altering in any way the composition of the product. One problem is that of adsorption of constituents, for example, preservatives, from the drug product (see section 6.2.8). The permeability of the packing material to gases or liquids should also be considered, since this may result in deterioration of the product due to oxidation, hydrolysis or loss of volatile ingredients. Monolayers are useful models by which the properties of... 

The application (or Type II DMF) should include a detailed description of the complete container closure system for the bulk drug substance as well as a description of the specific container, closure, all liners, inner seal, and desiccant (if any), and a description of the composition of each component. A reference to the appropriate indirect food additive regulation is typically considered sufficient to establish the safety of the materials of construction. The tests, methods, and criteria for the acceptance and release of each packaging component should be provided. Stability studies to establish a retest period for bulk drug substance in the proposed container closure system should be conducted with fillers or desiccant packs in place (if used). Smaller versions that simulate the actual container closure system may be used. 

Physicochemical testing is performed to characterize the physical and chemical properties of a plastic to insure that the composition of the synthetic medium will not compromise the quality of the drug being stored within it. To perform these tests, samples of plastic identical to the material being used in the primary package are subjected to an extraction procedure—to dissolve in an extraction solution leachable compounds that are at risk of entering the pharmaceutical preparation. This extraction solution is then subjected to analysis to evaluate the identity and quantity of leachants. For most plastics, the appropriate extraction medium is purified water, but elastomeric closures for use with injections should include extraction with three different extraction... 

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