FORCED DEGRADATION STUDIES - A TOOL FOR DETERMINATION OF STABILITY IN PHARMACEUTICAL DOSAGE FORMS
Forced degradation is the process of subjecting drug compounds to extreme chemical and environmental conditions to determine product breakdown levels and preliminary degradation kinetics, and to identify degrading species. They are used to facilitate the development of analytical methodology, to gain a better understanding of active pharmaceutical ingredient (API) and drug product (DP) stability, and to provide information about degradation pathways and degradation products. It is particularly useful when little information is available about potential degradation products. These studies also provide information about the degradation pathways and degradation products that could form during storage. Forced degradation studies may help facilitate pharmaceutical development in areas such as formulation development, manufacturing, and packaging, in which knowledge of chemical behavior can be used to improve a drug product. In order to fulfill development and regulatory needs, this publication provides a roadmap for when and how to perform studies, helpful tools in designing rugged scientific studies, and guidance on how to record and communicate results.