A review on forced degradation studies, stability indicating method and stability profile of few antiviral drugs

Abstract

The aim of the study is to provide with available literature on regulatory aspects and protocols for forced degradation investigations and
stability indicating methods of various drug substances and their drug products too. Also, it provides information on stability profile of
various antiviral drugs. Forced degradation is a procedure in which the drug material or drug product is exposed to conditions that are more
severe than accelerated once, resulting in the creation of different degradants which helps in determining the stability profile of molecules.
Stability indicating technique is a process in which the reduction in the amount of active pharmaceutical ingredient (API) in drug product
(DP) due to degradation is determined quantitatively. The use of antiviral drugs has increased to treat various viral diseases. This has resulted
in development of resistance of the drugs towards the targeted virus. These drugs have emerged as a new challenge for estimation in general
and researchers. So, there is a pressing need to focus on this antiviral class of drugs and also to study about stability behaviour of these drugs
so far. The current literature discusses about concept of forced degradation studies, stability indicating methods and degradation profiles of
numerous antiviral medicine in bulk and varied dosage forms by using conventional as well as newly developed methods. The current article
also discusses the strategies and stepwise approach for developing stability indicating methods. Forced degradation techniques are helpful
in determining the degradation pathway and structure elucidation of degradants produced which in turn helps for selecting proper storage
conditions as well as to modify the manufacturing process of drug moiety or drug product.