2. Container/content interactions

Plastic packaging materials are increasingly used in the pharmaceutical industry as a replacement for heavy, brittle glass. However, these materials are not inert to the solutions they contain. Migration between container and contents can occur in both directions:

• binding of the solution's constituents to the packaging, leading to a drop in concentrations and therefore in the drug's therapeutic efficacy;

• release of additives from the plastic material into the solution, the levels of which are limited due to their potentially toxic nature.

Analysis of additives present in solution can be carried out by thin-layer chromatography (TLC) after standardized contact between solution and packaging in accordance with International Conference on Harmonization (ICH2) standards:...