FORMULATION AND EVALUATION OF PULSATILE DRUG DELIVERY SYSTEMS OF GLIPIZIDE FOR THE MANAGEMENT OF TYPE-II DIABETES MELLITUS

Abstract

The objective of the present study was to fabricate and evaluate a chronomodulated pulsatile drug delivery system to maintain the blood glucose level by releasing the drug at a predetermined time interval. The basic design of the system consisted of a glipizide microspheres filled in a formaldehyde treated impermeable gelatin capsule body which is plugged with a bilayer tablet plug (glipizide in fast releasing layer and erodible polymer plug made of 20% guar gum). Plugs were prepared by direct compression method using super disintegrant (Croscarmellose) in fast releasing layer and different percentage of guar gum in erodible tablet layer. The microspheres were successfully prepared from ethylcellulose and eudragit using emulsification-solvent evaporation method. Formaldehyde treated capsules, bilayered tablet plugs and microspheres were evaluated for various parameters. A chronomodulated pulsatile drug delivery system containing glipizide bilayer tablet and glipizide microspheres was prepared and was evaluated for weight variation and in vitro drug release studies. The results concluded the programmable pulsatile release has been achieved with modified pulsincap of Glipizide. Formulation FG-2, FG -5, FG -8 and FG -11 were chosen as best formulations. The dosage form can be taken half an hour before the breakfast and will deliver its first pulse as an immediate dose (5 mg) within 30 minutes and second pulse of sustained release microspheres (equivalent to 10 mg Glipizide) during noon which will maintain the drug concentration throughout the day till mid night and thus consistent with the demands of the chronotherapeutic drug delivery.Keywords: Pulsincap, chronomodulated, glipizide, guar gum, croscarmellose.Â