Review on Forced Degradation Study of Statins

Priyanka S. Sutar, Manojkumar K. Munde, Vijaya S. Vichare, Nilesh S. Kulkarni
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Abstract

The degradation of new drug ingredients and drug products in more severe settings than accelerated conditions is referred to as forced degradation research. Forced degradation experiments were carried out to demonstrate the specificity of stability-indicating methodologies, providing insight into degradation pathways and drug degradation products, and assisting in the understanding of degradation product structures., identifying degradation products that could be spontaneously generated during storage and use of drugs and to facilitate improvement in manufacturing process and formulation corresponding with accelerated stability studies Statins, a type of lipid-lowering medication, are the most commonly prescribed and are an example of an unstable drug. In the presence of high temperatures and humidity, statins are susceptible to hydrolysis. As a result, the review discusses various studies of statin drug forced degradation studies. To describe the drug's intrinsic stability, the terms atorvastatin, Fluvastatin, pitavastatin, ruvastatin, simvastatin, and pravastatin are used. assist the selection of formulations and packaging as well as proper storage conditions.
他汀类药物强制降解研究进展
新药成分和药品在比加速条件更严重的环境下的降解被称为强制降解研究。进行强制降解实验以证明稳定性指示方法的特异性,为降解途径和药物降解产物提供洞察,并协助理解降解产物结构。,识别在药物储存和使用过程中可能自发产生的降解产物,并促进与加速稳定性研究相对应的制造过程和配方的改进。他汀类药物是一种降脂药物,是最常用的处方,也是不稳定药物的一个例子。在高温和高湿环境下,他汀类药物容易水解。因此,本综述讨论了他汀类药物强制降解研究的各种研究。为了描述药物的内在稳定性,使用了术语阿托伐他汀、氟伐他汀、匹伐他汀、鲁伐他汀、辛伐他汀和普伐他汀。协助选择配方和包装以及适当的储存条件。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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