DEVELOPMENT AND IN-VITRO ASSESSMENT OF A BILAYER TABLET FOR GLIBENCLAMIDE AND PIOGLITAZONE HCL: A NOVEL APPROACH TO DIABETES MANAGEMENT

The research study aims to prepare and characterize bilayer tablets that combine Glibenclamide, a sulphonyl urea and Pioglitazone HCl, a thiazolidinedione for enhancing glycaemic control in Type 2 Diabetes. The bilayer design incorporates an immediate-release layer of Glibenclamide for rapid onset of action and a sustained-release layer of Pioglitazone HCl to maintain prolonged therapeutic levels. Using wet granulation process, a 400 mg bilayer tablet was prepared. Eight formulations of the immediate and sustained release layers were prepared using different quantities of Crospovidone and sodium starch glycolate, as well as different viscosity grades of HPMC K4 M and HPMC K100M polymers. The FTIR spectra confirmed that the medication and polymers do not interact chemically. DSC analysis was conducted for an optimized formulation, and no incompatibility was discovered. According to dissolution rate studies of bilayer tablets it was observed that the bilayer tablet showed 94.6% while the marketed tablet showed 82.5% release over a 12-hour period. The optimized formulation of drug release data demonstrated the best fit into zero-order kinetics and the Higuchi model of kinetics. According to ICH criteria, stability study data showed no appreciable variations in drug content or dissolution rates over three months. Thus, a novel bilayer tablet formulation of Glibenclamide and Pioglitazone HCl was successfully developed by combining both immediate and sustained release layers.