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.

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抗癫痫药物及其他药物的强制降解研究迷你回顾

在本综述中，抗癫痫药物的强制降解研究以及在比加速条件更严酷的条件（即 40 ± 2°C、75 ± 5% 相对湿度）下对原料药和产品进行验证的稳定性指示测定方法的开发），原料药和药品发生降解被称为强制或应力降解。了解药品在各种环境条件下储存过程中产生的杂质。允许的降解限度为5-20%。超过 20% 的降解是异常的，必须进行调查。任何监管指南均未提及酸或碱水解的 pH 条件、热降解的温度或氧化剂的浓度。只有国际协调会议 (ICH) 指南 Q1B 光稳定性并规定光源必须是紫外光和可见光的组合。强调了上述技术在监管必要性方面的缺点。讨论了“托吡酯、氨己烯酸、拉科酰胺、噻加宾、左乙拉西坦和唑尼沙胺”等抗癫痫药物强制降解研究的系统方法。本综述有助于研究人员了解新型抗癫痫药物的稳定性指示方法的开发和验证以及在特定降解条件下降解的药品的特性。强调了上述技术在监管必要性方面的缺点。讨论了“托吡酯、氨己烯酸、拉科酰胺、噻加宾、左乙拉西坦和唑尼沙胺”等抗癫痫药物强制降解研究的系统方法。本综述有助于研究人员了解新型抗癫痫药物的稳定性指示方法的开发和验证以及在特定降解条件下降解的药品的特性。强调了上述技术在监管必要性方面的缺点。讨论了“托吡酯、氨己烯酸、拉科酰胺、噻加宾、左乙拉西坦和唑尼沙胺”等抗癫痫药物强制降解研究的系统方法。本综述有助于研究人员了解新型抗癫痫药物的稳定性指示方法的开发和验证以及在特定降解条件下降解的药品的特性。