Abstract

IMPORTANCE OF FORCED DEGRADATION STUDY IN PHARMACEUTICAL INDUSTRY— A REVIEW

Sandesh R. Chavan*, Avinash M. Bhagwat, Mahesh Rao and Atul P. Choudhari

Abstract

Forced degradation is the process or state in which new drug substance and drug products are with the conditions which are more severe than accelerated stability conditions. The stability of drug substance is a critical parameter which may affect purity, potency and safety. Changes in drug stability can risk patient safety by formation of a toxic degradation product or deliver a lower dose than expected. Therefore it is essential to know the purity profile and behavior of a drug substance under various environmental conditions. The real and accelerated stability of the dosage forms are generally studied in pharmaceutical industry but force degradation study has its importance before starting a new formulation. It is required to demonstrate specificity of stability indicating methods and also provides an insight into degradation pathways of degradation products of the drug substance and helps in elucidation of the structure of the degradation products. Forced degradation studies show the chemical behavior of the molecule which in turn helps in the development of formulation and selection of packaging material. ICH guidelines demonstrate certain degradation conditions like light, oxidation, dry heat, acidic, basic, hydrolysis etc. ICH Q1A, QIB and Q2B exemplify the forced degradation studies. the present review discusses the current process and scenario in performance of forced degradation studies, its method and its importance in new formulation development.

Keywords: Degradation condition, Degradation product, Forced degradation, Stability.