Design and Development of Pulsatile Drug Delivery System for Anti Diabetic Drug

Abstract

Pulsatile drug delivery system are recently introduced system to deliver the drugs at the specific site of action at the right time and in the required concentration, which are designed according to the circadian rhythm of the body and it is most suitable, convenient, safe, economic and highly efficient method to deliver the drug. Miglitol is a drug commonly used in the management of Type 2 diabetes mellitus which belongs to the category of alpha-glucosidase enzyme inhibitor. newlineThe present study was made to develop the pulsatile drug delivery of Miglitol. Pulsincap and press coated tablets for the timed release of Miglitol were formulated and evaluated. Miglitol pulsincap prepared with different concentrations of hydrogel plug of gelatin, HPMC K4M and sodium alginate were optimized by conducting various trials. Press coated tablets of Miglitol were prepared with different ratios of glyceryl behenate, ethyl cellulose, HPMC and L-HPC that were optimized. The in vitro dissolution studies revealed that the formulated pulsincap and press coated tablets of Miglitol released the desired concentration of the drug at pre-determined time points. The animal studies confirmed that the pharmacokinetic and Pharmacodynamic parameters of Miglitol press coated tablets and pulsincap formulations were comparable to standard Miglitol marketed tablets. The stability studies on the selected formulation of Miglitol pulsincap and press coated tablets were found to be stable. Comparative studies on in vitro drug release profile of Miglitol pulsincap and press coated tablets were found to have three pulses of drug release with desirable lag time when compared to the marketed conventional Miglitol tablets which contains only single dose of drug. Hence it may be concluded that the newly formulated pulsatile drug delivery systems of Miglitol produce effective control of the increased blood glucose level after intake of meals by allowing the drug to release after a lag time (after meals). newline