Abstract

Forced Degradation Studies & Protocols – Industry Perspective

Alok Kumar Chaudhary, Manager, Fresenius Kabi Oncology Limited

Pharmaceutical industry worldwide is a strongly regulated segment with quality and safety expectations increasing subsequently. Forced degradation studies of pharmaceuticals, although are not recommended as part of formal stability programme but are advised as essential by globally recognized guidelines like ICH or agencies like FDA, as part of drug development. Guidelines recommend forced degradation studies for identification of various degradants in drug substances and drug products as well as for degradation pathways. Additionally, challenging the analytical method for its stability indicating nature and capability to discernment degradation products in formulations that are related to drug substances are other requirements. Despite of regulatory requirements of forced degradation studies, agencies don’t define protocols for forced degradation studies. Type of degradants, target % degradation or mass balance is not advised in most of the guidelines. Proposed speak will address the industrial practices on acid-alkali hydrolysis, oxidation, photo degradation, thermal and humidity degradation studies. Recent proposals for upgrading the existing degradation practices with a target of better mass balance and degradation closer to real time conditions will be the part of discussion. Solubility concerns in degradation mixture and approaches establishing direct correlation of degradation between assay and related substances methodologies will be addressed alongwith.