International Journal of Pharmaceutics & Drug Research

Prashant Singh, B.K. Dubey, Muklesh Kumar Patel, Deepak Basedia

ABSTRACT

The present study was aimed at the formulation development and evaluation of bilayer tablets containing antidiabetic drugs, metformin and saxagliptin, for the effective management of type 2 diabetes mellitus. The bilayer tablet was designed to provide an immediate release of metformin for rapid reduction of blood glucose levels and a floating sustained release of saxagliptin for prolonged therapeutic effect. The powder blends of both layers were evaluated for pre-compression parameters such as bulk density, tapped density, Carr’s index, and Hausner’s ratio to determine their flow properties. The prepared tablets were further evaluated for post-compression parameters including hardness, friability, thickness, weight variation, drug content, and in-vitro disintegration time. The metformin immediate release layer showed rapid disintegration with optimized formulation IF7 exhibiting a disintegration time of 40 ± 5 seconds. The saxagliptin floating sustained release tablets showed acceptable physical characteristics and demonstrated floating lag time ranging from 28 to 42 seconds with total floating duration greater than 12 hours. The optimized bilayer tablet showed satisfactory hardness (5.9 ± 0.3 kg/cm²), friability below 1%, and uniform drug content for both drugs. In-vitro dissolution studies revealed that the immediate release layer released 96.65% of metformin within 15 minutes, whereas the floating sustained release layer of saxagliptin showed a controlled drug release of 98.78% over 12 hours. The results indicate that the developed bilayer floating tablet system successfully achieved rapid onset of action along with sustained drug release. Therefore, the formulated bilayer tablets of metformin and saxagliptin may provide improved therapeutic efficacy, prolonged drug action, and better patient compliance in the treatment of type 2 diabetes mellitus.

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