Packaging-Induced Interactions and Degradation

Abstract

Forced degradation studies are typically used to determine the potential degradation products that may form during formal stability studies that are conducted on drug substances and drug products. Occasionally, impurities are detected in stability studies that were not observed in the forced degradation studies. Such observations can result from poorly designed forced degradation studies (of the drug substance and/or drug product) that failed to generate all of the relevant degradation products. Potential interaction of the drug with packaging or shipping materials may not be effectively captured unless studies are designed to look for these potential interactions. Migration of materials into drug substance or product may result in simple contamination. However, migratory species may also be reactive and form new drug-related impurities. Several examples are shared to highlight drug substance and drug product interactions with packaging components that fit into the above categories.