Cost effective formulation and process development of bilayer tablet containing fixed dose combination of Saxagliptin and Metformin hydrochloride using QbD for fast onset and sustained action

Abstract

Diabetes Mellitus (DM) is a major cause for age related mortality. The mortality newlinerate associated with DM increases two times in a decade, in spite of improvement newlinein knowledge of its pathophysiology and the availableness of efficient treatment newlinestrategies. This is a matter of serious consideration because people with diabetes newlineare seen to have higher mortality and lower life expectancy than people without newlinediabetes. Type 2 DM (T2DM) is the most commonly found type of DM. The newlinepathophysiology of diabetes mellitus includes insulin resistance, pancreatic and#946;-cell newlinedysfunction, incretin deficiency and incretin resistance in GIT. Therefore, for newlinebetter and effective treatment, a combination of two or more drugs is necessary to newlinecontrol plasma glucose levels by different mechanisms. Saxagliptin (SAXA) is a newlinenew generation oral hypoglycemic agent that enhances the action of the incretin newlinesystem by inhibiting dipeptidyl peptidase-4 (DPP-4) hormone that deactivates newlineincretin hormone. This is used alone or in combination with other agents due to its newlinedistinct mechanism of action and better safety profile than older oral newlinehypoglycemic agents. Metformin (MET) has been a proven anti-diabetic drug for newlinemany decades, so the combination of SAXA with MET has resulted in better newlineglycemic control. newline