Development And In Vitro Evalaution Of Acarbose Osmotic Tablets Using Box-Behnken Design Approach

Abstract

The present research work was aimed to develop an osmotic drug delivery system at a controlled rate for an antidiabetic drug, acarbose. The formulations/tablets were composed of acarbose drug surrounded by microporous film containing cellulose-acetate phthalate (bio-compatible polymer) along with water soluble pore forming agent polyethylene glycol. The osmotic tablets were formulated employing wet granulation technique and statistically optimized via Box-Behnken experimental design approach utilizing design expert 360 version 12.0. These tablets were characterized for before and after compression parameters. Effect of three independent variables i.e. NaCl as an osmotic agent, PVP K30 as binder as well as film forming agent and Microcrystalline cellulose (MCC) as binder was evaluated on % drug release at 16^th hrs and % swelling index. High swelling index was observed in the optimized formulation F10 (135±0.23%) exhibiting cumulative drug release of 75.46% at 16^th hrs. The significant results were obtained after fitting acquired data in ANOVA. Optimized batch also exhibited controlled release of drug over 24 hrs as it was found to follow zero order drug release kinetics. Stability studies indicated that all optimized formulations proved stable as evidenced by negligible change in drug content and other parameters over the time. These findings suggest that the formulated osmotic tablet loaded with acarbose have proved to be good formulations and would be proved effective for the treatment of diabetes mellitus.