Journal: Drug Invention Today

Article Id: JPRS-CPS-00002095
Title: Forced degradation studies: Regulatory guidance, characterization of drugs, and their degradation products - a review
Category: Chemistry and Parallel Synthesis
Section: Review Article
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    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.

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    Author(s) Name:

    Sowmyalakshmi Venkataraman1 *, Merugu Manasa2

    Affiliation(s) Name:

    1Department of Pharmaceutical Chemistry and Analysis, School of Pharmaceutical Sciences, Vels Institute of Science, Technology & Advanced Studies (VISTAS), Pallavaram, Chennai, Tamil Nadu, India,

    2 Research Scholar, Department of Pharmaceutical Chemistry & Analysis, School of Pharmaceutical Sciences, Vels Institute of Science, Technology & Advanced Studies (VISTAS), Pallavaram, Chennai, Tamil Nadu, India

    *Corresponding author: Dr. Sowmyalakshmi Venkataraman, Department of Pharmaceutical Chemistry & Analysis, School of Pharmaceutical Sciences, Vels Institute of Science, Technology & Advanced Studies (VISTAS), Pallavaram, Chennai - 600 117, Tamil Nadu, India.

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    Author:

    Sowmyalakshmi Venkataraman1 *, Merugu Manasa2

    Title:Forced degradation studies: Regulatory guidance, characterization of drugs, and their degradation products - a review
    Journal:Drug Invention Today
    Vol(issue):10 (Feb)
    Year:2018
    Page No: (137-146)
  • Experimental Methods Keywords

    Methodology: Characterization, Forced degradation studies, Method development, Regulatory guidance, Stability studies
    Research Materials:Various drug substances and their products

Keywords

Characterization Forced degradation studies Method development Regulatory guidance Stability studies

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