Drug Degradation Mechanisms

Drug Degradation Mechanisms

Steven Baertschi, Ph.D.
President, Baertschi Consulting, LLC
Indianapolis, IN, USA

Developing an understanding of the degradation pathways available to drug substances and associated formulated products is an important part of establishing the “intrinsic stability” characteristics of a drug.  This talk will focus on several case studies of degradation mechanisms, highlighting the importance of a “chemistry-guided” approach that includes structure elucidation of degradation products, utilization of kinetics, analytical tools, and experiments that are designed to uncover critical mechanistic aspects.  The mechanistic insights gained from this approach will be used to illustrated how such understanding can reveal the reactive sites in the drug molecule, potential analytical pitfalls, and implications for stabilization through formulation design and packaging.