Current Trends in Performance of Forced Degradation Studies and Stability Indicating Studies of Drugs
Journal Title: IOSR Journal of Dental and Medical Sciences (IOSR-JDMS) - Year 2017, Vol 17, Issue 2
Abstract
The stability of a drug substance (or) drug product is a vital parameter which may affect purity, safety and potency and. Changes in drug stability can threat patient safety by formation of a toxic degradation product or products or deliver a lower dose than expected. Therefore it is necessary to know the purity profile and behaviour of a drug substance under different environmental conditions. Forced degradation testing studies are those undertaken to degrade the sample deliberately. These studies, which may be undertaken in the development phase normally on the drug substances, are used to evaluate the overall photosensitivity of the material for method development purposes and/or degradation pathway elucidation. The purpose of stability testing is to give evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a retest period for the drug substance or a shelf life for the drug product and recommended storage conditions. Stress testing of the drug substance can aid to identify the likely degradation products, which can in turn help establish the degradation pathways and the intrinsic stability of the molecule and validate the stability indicating power of the analytical procedures used. The nature of the stress testing will depend on the individual drug substance and the type of drug product involved. Forced degradation studies show the chemical behavior of the molecule which in turn aids in the development of formulation and package. Examining degradation products under stress conditions is useful in establishing degradation pathways and developing and validating suitable analytical procedures. However, it may not be necessary to examine specifically for certain degradation products if it has been demonstrated that they are not formed under accelerated or long term storage conditions. This review discusses the latest trends in performance of forced degradation studies and also the development of stability indicating method.
Authors and Affiliations
Panchumarthy Ravisankar, Vaka Swathi, Puttagunta Srinivasa Babu, Md. Shaheem Sulthana, Sk. Gousepeer
Keywords
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