ABSTRACT:
The present study involves designing and development of a bilayer tablet of Metformin HCl (MET) and Glimepiride (GLP) to offer immediate release of GLP and gastroretentive layer of MET. Bilayer tablets containing two layers i.e. immediate release layer formulated using super disintegrant Sodium starch glycolate and gastroretentive layer formulated with polymers like HPMC K4M and HPMC K100M to modulate the biphasic drug release. Wet granulation method was employed to formulate bilayer tablets. Fourier Transform Infrared Spectroscopy (FTIR), Differential Scanning Calorimetry (DSC), Scanning Electron Microscopy (SEM) were used for physicochemical compatibility and stability studies of the tablets. Accelerated stability studies were followed in compliance with ICH guidelines. The in vitro release profile shows desired biphasic release behavior after storage at accelerated condition (40°C± 2°C and 75%RH ± 5% RH) for 6 months. Biphasic drug release pattern was successfully achieved through the formulation of bilayer tablets that are stable and capable of releasing the drug over 12 hrs.