In vitro assessment of immediate release Dapagliflozin tablets for type 2 diabetes mellitus treatment

The study explores therapeutic strategies for diabetes mellitus, focusing on improving therapeutic outcomes and patient compliance through the development and characterization of an immediate release formulation of dapagliflozin. Eight formulations were developed using a wet granulation process with several super-disintegrating agents and characterized by pre-compression parameters such as angle of repose (40.2 to 61.02), Hausner ratio (1.30 to 1.5), Carr’s index (23.5 to 33.3), physical attributes (weight (145–155 mg), thickness (4.42±0.04 to 4.46±0.05 mm), hardness (3.7–5.6 kg/cm2), friability (<1%)), and disintegration time. Furthermore, FT-IR, SEM, and TGA were conducted, which revealed no plausible drug-excipient interaction. In-vitro dissolution studies were conducted and the release profile was determined as F1 (80.50±5.2) > F3 (75.97±1.4) > F2 (75.30±3.3) > F5 (74.14±2.3) > F8 (70.13±3.7) > F7 (68.12±4.1) > F6 (66.45±3.1) > F4 (54.74±1.3) > pure drug (38.14±2.1) within 30 minutes, while the F1 formulation complied with the USP requirements for immediate release formulation. Additionally, the F1 formulation's drug release profile significantly outperformed commercially available options, indicating its potential to enhance glycemic control and patient adherence in T2DM management, as per the findings. Bangladesh J. Sci. Ind. Res. 59(3), 139-148, 2024