Control of Drug Degradation

Abstract

This final chapter provides a high level overview of the strategies for controlling drug degradation based on the understanding of the degradation pathways and mechanisms. The overview consists of thirteen discussion topics, which cover the strategies for controlling drug degradation from the perspectives of (1) early phase drug design and development, (2) consideration of multiple degradation pathways, (3) formulation development with regard to the use of antioxidants, preservatives, chelating agents, control of pH, variability of excipient impurities, and the use of excipients that shield or protect APIs from degradation, (4) the impact of manufacturing process, and (5) selection of proper packaging materials for the control of moisture, oxygen, and light induced degradation.