Forced Degradation Studies on Anti-Cancer Drugs: A Comprehensive Review

Abstract

Forced degradation studies are essential to understanding the stability, safety, and efficacy of anti-cancer drugs, playing a critical role in ensuring their reliability throughout the product lifecycle. These studies expose pharmaceutical compounds to controlled stress conditions—such as heat, light, oxidation, and hydrolysis—to simulate long-term storage and identify degradation pathways. Anti-cancer drugs, due to their intricate molecular structures and sensitivity, are particularly prone to degradation, making these studies indispensable in pharmaceutical development and regulatory compliance. This review explores the fundamental principles of forced degradation, highlights common degradation mechanisms, and discusses advanced analytical techniques used to evaluate the stability of anti-cancer drugs. Case studies of widely used therapies, including doxorubicin and paclitaxel, illustrate the challenges and mitigation strategies. Furthermore, this paper evaluates regulatory frameworks, such as ICH Q1A(R2), and examines future trends, such as artificial intelligence in predictive modelling. These insights emphasize the significance of forced degradation studies in ensuring the safety and effectiveness of anti-cancer drugs.