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Home > Archives > Volume 20, No 11 (2022) > Article

DOI: 10.14704/nq.2022.20.11.NQ66331

Stress testing and impurity profiling of DPP4 inhibitors: A review

Pratima Kumari, Ritchu Babbar, Ravinder Singh, Hitesh Chopra, Balraj Saini

Abstract

Stress testing studies and impurity profiling has become an integral part of the new drug application. 6 Stress testing studies are done to determine the intrinsic stability of the drug substance as well as 7 drug product. By knowing the degradation behavior one can predict the efficacy and safety profile of 8 the pharmaceutical product, shelf life and storage conditions for the post manufacturing. The 9 International Conference on Harmonization (ICH) guidelines are providing the basis and requirement 10 for the conduct of stress testing studies on new drug substance and new drug product by exposing 11 to acid or basic hydrolysis, oxidative, photolytic and thermal degradation conditions. Diabetes 12 mellitus (DM) is a major metabolic disorder affecting the lives of a large population across the world. 13 DM is characterized by hyperglycemia, hyperlipidemia as well as resistance to the insulin.For DM 14 management, we mainly rely on metformin, sylfonylureas, thiazolidiediones, newer classes including 15 incretin mimetics/analogs, dipeptidylpeptidase- 4 (DPP4) inhibitors. In the present review, the 16 authors have reviewed the literature based on stress testing studies and impurity profiling of 17 DPP4inhibitors.

Keywords

Stress testing; Diabetes mellitus; Hypoglycemic agents; DPP4 Inhibitors; ICH

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