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- Title
Forced degradation studies: Regulatory guidance, characterization of drugs, and their degradation products - a review.
- Authors
Venkataraman, Sowmyalakshmi; Manasa, Merugu
- Abstract
Aim: The aim of this study is to consolidate the literature available on regulatory aspects and protocols for forced degradation studies of various drug substances and their products into a comprehensive review. Background: Forced degradation is a process in which different stress conditions are applied over drug substances and which in turn different degradation products are produced. These studies are mainly used for the determination of stability of molecule under accelerated conditions. It is known that regulatory documentation process, selection of proper storage and package conditions, and selection of formulation are dependent on the stability of molecules. Objective: The present review discusses about various regulatory aspects, methodology for forced degradation studies, and degradation profiles for various drugs. Method: In forced degradation process, the drug substance and drug products are subjected to severe accelerated conditions to determine their stability. For determination of specificity of stability methods, it is necessary to determine the stability under forced degradation conditions. Conclusion: For determination of degradation pathways and structural elucidation of degradants produced, these forced degradation studies are helpful. It is also used to select the storage conditions and improve the manufacturing process of formulations.
- Subjects
DRUG interactions; MEDICAL protocols; BIODEGRADATION; DRUG development; DRUG storage
- Publication
Drug Invention Today, 2018, Vol 10, Issue 2, p137
- ISSN
0975-7619
- Publication type
Article