Development and in Vitro Evaluation of Multi/bi-bilayer Tablet Dual-release Formulations of Vildagliptin and Dapagliflozin for the Treatment of Type 2 Diabetes Mellitus

Introduction: This study aimed to develop an innovative bilayer tablet formulation of dapagliflozin and vildagliptin to increase therapeutic outcomes and patient compliance in diabetes management. Methods: By employing wet granulation, immediate-release, and sustained-release layers were formulated using various super-disintegrating and release-retarding agents, respectively. Several pre-compression parameters were utilized, such as Carr’s index, Hausner ratio, physical attributes (weight variations, friability, hardness), and disintegration time. Drug-excipient interactions were determined through employing FTIR, SEM, DSC, and TGA. In-vitro dissolution studies were performed to assess the release kinetics of these formulations. Results: For immediate-release dapagliflozin, our earlier study demonstrated that the formulations showed Carr’s index (23.5-33.3), physical attributes (weight (145–155 mg), thickness (4.42 ± 0.04 -4.46 ± 0.05 mm), hardness (3.7-5.6 kg/cm2), friability (<1%),…