Mini Review on Forced Degradation Studies on Anti-Epileptic Drugs and Beyond

Abstract

Abstract In this review on the forced degradation studies on anti-epileptic drugs and the development of validated stability-indicating assay methods for drug substances and products at a condition more severe than accelerated condition (i.e. 40 ± 2°C, 75 ± 5% relative humidity), the drug substance and drug product undergo degradation is known as forced or stress degradation. To know about the impurities developed during the storage of drug products in various environmental conditions. The limit of degradation allowable is 5–20%. More than 20% of degradation is abnormal and must be investigated. Any regulatory guidelines do not mention the pH conditions for acid or base hydrolysis, the temperature for thermal degradation or the concentration of the oxidation agent. Only International Conference on Harmonization (ICH) guidelines Q1B photostability stability and states that light sources must be a combination of UV and visible light. The shortcomings of mentioned techniques with appreciation to regulatory necessities are highlighted. A systematic method for the forced degradation studies on anti-epileptic drugs such as “Topiramate, Vigabatrin, Lacosamide, Tiagabine, Levetiracetam and Zonisamide” is discussed. This review helps researchers to get an idea about stability-indicating methods of development and validation for newer antiepileptic drugs and the characteristics of drug products that degrade under specific degradation conditions.