SIGNIFICANCE OF FORCED DEGRADATION STUDIES FOR DRUG SUBSTANCE AND DRUG PRODUCTS WITH REFERENCE TO ANTIHYPERTENSIVE AGENTS

Abstract

Stability testing is used to provide evidence of how the quality of an Active Pharmaceutical Ingredient (API) or drug product varies with time under the infuence of a variety of environmental factors such as temperature, humidity and light. If drug product is not stable under various environmental conditions, it may affect the patient safety by formation of a toxic degradation product(s) or deliver a lower dose than expected. Stress testing of the API can help to identify the likely degradation products, which, in turn, can help to establish the degradation pathways and the intrinsic stability of the molecule. Forced degradation study is a process in which the natural degradation rate of a pharmaceutical product is increased by applying an additional stres by which stability of a drug substance or a drug product with effects on purity, potency and safety can be predicted. The present review summarizes the forced degradation study of antihypertensive agents, where degradation products for different stress conditions have been reported. As per review, maximum degradation products have been reported by alkaline, oxidative and photolytic stress conditions.