Study On Preformulation Optimization And Characterization Of Ir Layer Of Saxagliptin and SR Layer Of Metformin Hydrochloride

Abstract

Age-related mortality is primarily caused by diabetes mellitus (DM). Even though our understanding of the biology of diabetes mellitus has improved and effective treatment options are more readily available, the mortality rate linked with the disease doubles every ten years. People with diabetes are known to have greater death rates and shorter life expectancies than those without the disease, thus this is a crucial issue to take into account. The most typical kind of DM is type 2 (T2DM). Insulin resistance, pancreatic beta-cell dysfunction, incretin deficit, and incretin resistance in the gastrointestinal tract are all factors in the pathogenesis of diabetes mellitus. Therefore, to reduce plasma glucose levels via various mechanisms, a combination of two or more medicines is required for better and more effective treatment. The oral hypoglycemic medication saxagliptin (SAXA), which inhibits the hormone dipeptidyl peptidase-4 (DPP-4), which inactivates incretin hormone, improves the function of the incretin system. Due to its unique method of action and higher level of safety compared to prior oral hypoglycemic medicines, this is used either alone or in conjunction with other medications. The addition of SAXA to the anti-diabetic medication metformin (MET), which has been clinically shown effective for many years, has improved glycemic control. The quality by testing (QbT) methodology used in conventional development processes requires ongoing testing to assess quality. These procedures are set in stone, resistant to modification, and solely concerned with process reproducibility. This method does not permit adjustment of the material and process controls. Regulatory organisations have given guidelines for the industries to increase the understanding of the process and the quality of the product in order to address the inadequacies of the conventional method. In order to guarantee product quality in the pharmaceutical business, it intends to switch from the conventional technique QbT to a scientific approach qual