TECHNICAL CONSIDERATIONS OF FORCED DEGRADATION STUDIES OF NEW DRUG SUBSTANCES AND PRODUCT: REGULATORY PERSPECTIVES

Abstract

Forced degradation studies of new drug substances and drug product are important to help develop and demonstrate specificity of stability indicating methods and provide knowledge about possible degradation pathways and degradation products of the active ingredients and help elucidate the structure of the degradants. They were also useful in the investigation of chemical and physical stability of crystal forms. It is better to start degradation studies earlier in the drug development process to have sufficient time to gain more information about the stability of the molecule. This information will in turn help improve the formulation manufacturing process and determine the storage conditions. As no specific set of conditions is applicable to all drug products and drug substances and the regulatory guidance does not specify the conditions to be used, this study requires the experimenter to use common sense. The aim of any strategy used for forced degradation is to produce the desired amount of degradation i.e., 5–20%. Adequate degradation required to understand the probable degradants for the evaluation of stability indicating method. It has become mandatory to perform stability studies of new drug moiety before filing in registration dossier. The stability studies include long-term studies (12 months) and accelerated stability studies (6 months).Key Words: Force Degradation, Stability Indicating, ICH, Drug substances, Drug product.Â