Formulation and Evaluation of Bilayer Tablet of Metformin HCl and Sitagliptin

Abstract

The treatment of Type 2 Diabetes Mellitus (T2DM) often necessitates a combination therapy to achieve optimal glycemic control. Metformin HCl, a biguanide, and Sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, are commonly prescribed together due to their complementary mechanisms of action. This study aims to develop and evaluate a bilayer tablet containing Metformin HCl and Sitagliptin, designed to provide immediate release of Sitagliptin and extended-release of Metformin HCl. The bilayer tablets were formulated using direct compression and wet granulation techniques, and various parameters including shape of tablet, tablet dimension, weight variation, hardness, friability, drug content, and in vitro dissolution profiles were evaluated. The results indicated that the formulated bilayer tablets met the desired specifications for physical characteristics and demonstrated effective controlled release, thereby enhancing patient compliance and therapeutic efficacy.