RESUMEN
PURPOSE: To develop controlled release osmotic pump tablets (COPT) of glipizide (GZ) solid dispersion (SD). METHODS: In elementary osmotic pump (EOP) tablets, an osmotic core with the drug is surrounded by a semi-permeable membrane which is drilled with a delivery orifice. COPT tablets eliminate the need of drilling process as controlled release can be achieved by the presence of osmogen in the coating. Poorly water soluble drug molecule cannot give satisfactory drug release hence GZ solid dispersion was prepared in the present study. The SDs having different ratio of drug to Poloxamer (PXM) 188 were prepared by hot melt method and optimized by solubility study, drug content estimation and in vitro dissolution study. Effect of two independent variables, amount of osmogen (potassium chloride) and hydrophilic polymer (polyethylene oxide WSR 303), were investigated using 3(2) factorial design. Core and coated tablets were evaluated for pharmacotechnical parameters. In-vitro drug release profiles of COPT tablets were compared with marketed with push-pull osmotic pump tablet, Glucotrol XL. RESULTS: Prepared core and coated tablets showed acceptable pharmacotechnical parameters. Drug release was directly proportional to initial level of hydrophilic polymer, but inversely related to the osmogen, confirming osmotic mechanism. Zero order drug release pattern was achieved which was comparable to marketed product. CONCLUSION: Novel oral controlled release of glipizide was successfully achieved by incorporating glipizide solid dispersion into osmotic system.