Formulation, Optimization and Evaluation of Empagliflozin10 mg Tablets Manufactured by Direct Compression

Empagliflozin is a selective reversible inhibitor of Sodium-Glucose-Co-Transporter 2 (SGLT2) which is found exclusively in the renal proximal convoluted tubule. Thus inhibits the reabsorption of glucose leading to lowering of blood glucose level. It had been formulated to get the advantages of direct compression method excluding lactose. The incompatibility tests had been carried for each single excipient with the active ingredient and all excipients with the active ingredient except one in an interchangeable manner. Seven formulas were evaluated to conclude the optimum one. The Physical tests for each formula indicated that the sixth one should be selected to pass for the chemical test using isocratic HPLC in-house method, which shows acceptable result of 98 % and 99.41 % dissolution in 30 minutes. Further studies for stability testing showed satisfactory results.