Primary Processes of Free Radical Formation in Pharmaceutical Formulations of Therapeutic Proteins

Oxidation represents a major pathway for the chemical degradation of pharmaceutical formulations. Few specific details are available on the mechanisms that trigger oxidation reactions in these formulations, specifically with respect to the formation of free radicals. Hence, these mechanisms must be formulated based on information on impurities and stress factors resulting from manufacturing, transportation and storage. In more detail, this article focusses on autoxidation, metal-catalyzed oxidation, photo-degradation and radicals generated from cavitation as a result of mechanical stress. Emphasis is placed on probable rather than theoretically possible pathways.

Automated summary

Oxidation is a major route of chemical degradation in pharmaceutical formulations, but the mechanisms behind oxidation reactions, particularly the generation of free radicals, are not well understood. This article focuses on formulating these mechanisms based on information about impurities and stress factors from manufacturing, transportation, and storage. It specifically explores autoxidation, metal-catalyzed oxidation, photo-degradation, and radicals generated from cavitation due to mechanical stress, highlighting probable pathways rather than theoretical possibilities.