Abstract
Forced degradation study is the degradation of new drug substances and drug products in more severe conditions than accelerated conditions. Forced degradation study were conducted to demonstrate the specificity of stability-indicating methods, providing insight into degradation pathways and drug degradation products, assisting in the elucidation 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 class of lipid-lowering medications, are the most widely prescribed drugs and an example of an unstable drug. Statins are susceptible to hydrolysis in the presence of high temperatures and humidity. Therefore, the review discusses various studies of forced degradation studies in six statins drug (atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin, and simvastatin) to describe the drug's intrinsic stability thus it can assist the selection of formulations and packaging as well as proper storage conditions.
Highlights
The chemical stability of pharmaceutical molecules requires considerable attention because they affect the safety and efficacy of drug products [1]
The Food and Drug Administration (FDA) and International Council for Harmonisation (ICH) Guidelines state the requirements of stability testing data to understand how the quality of a drug substance and drug product changes over time under the influence of various environmental factors
In ICH guidelines, stress testing is intended to identify degradation outcomes that further assist in determining the intrinsic molecular stability and establishing degradation pathways, and to validate stability-indicating methods [2, 3]
Summary
The chemical stability of pharmaceutical molecules requires considerable attention because they affect the safety and efficacy of drug products [1]. The degradation studies showed that PTV was degraded significantly under acidic, alkaline, neutral, photolysis, thermal, oxidation, and light stress conditions (23.35 %-82.31 % drug degraded) [31].
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