FORMULATION AND EVALUATION OF BI-LAYER DOMPERIDONE FLOATING TABLETS

The present work was carried out to design the floating drug delivery system to minimize the side effect, improve the prolongation of action, to reduce the frequency of administration. The objective of the present investigation was to develop a bilayer-floating tablet (BFT) and evaluate for domperidone maleate using wet granulation technology. HPMC, K-grade and effervescent sodium bicarbonate formed the floating layer. The release layer contained domperidone and various ratios of polymers such as HPMC-K100M.The floating behavior and in vitro dissolution studies were carried out in a USP paddle apparatus 2 in simulated gastric fluid. Final formulation released approximately 104% drug in 12 h in vitro, while the floating lag time was 4 min and the tablet remained floatable throughout all studies. Statistically significant differences were found among the drug release profile from different formulations  Final formulation followed the Higuchi release model and showed no significant change in physical appearance, drug content, floatability or in vitro dissolution pattern after storage at 45°C/75% RH for three months. The release mechanism was explored and explained with zero order, first order equation. The results generated in this study showed that the profile and kinetics of drug release were functions of polymer type, polymer level and physico-chemical properties of the drug.