FORMULATION AND CHARACTERIZATION OF CONTROLLED SELF PORE FORMING TABLET OF ROSIGLITAZONE

Controlled self-pore forming osmotic tablet systems are advanced oral drug delivery systems designed to provide predictable and sustained drug release, independent of gastrointestinal pH and motility. The present study aimed to formulate and characterize a controlled self-pore forming tablet of rosiglitazone to enhance its therapeutic efficacy, improve patient compliance, and maintain prolonged plasma drug concentrations. Rosiglitazone tablets were prepared by direct compression using suitable osmotic agents, hydrophilic polymers, pore-forming agents, and excipients. The prepared formulations were evaluated for pre-compression parameters, including angle of repose, bulk density, tapped density, Carr's index, and Hausner's ratio, while post-compression studies included hardness, thickness, friability, weight variation, drug content, and content uniformity. The formulations were further characterized for in vitro dissolution, swelling behavior, membrane integrity, and stability under accelerated storage conditions. The effect of pore-forming agent concentration on drug release was also investigated to optimize the formulation. Among the developed formulations, the optimized formulation exhibited satisfactory physicochemical properties, excellent tablet integrity, uniform drug content, and a controlled release profile over the desired duration, following near zero-order release kinetics. Stability studies confirmed that the optimized formulation remained physically and chemically stable throughout the study period. The findings demonstrate that controlled self-pore forming osmotic tablets of rosiglitazone represent a promising oral controlled-release delivery system capable of providing reproducible drug release, minimizing fluctuations in plasma drug concentration, and improving therapeutic outcomes in the long-term management of type 2 diabetes mellitus.