Formulation and In Vitro Evaluation of Sustained Release Tablets of Domperidone

The present investigation is concerned about the development of sustained release tablets of domperidone, with the approach of enhancing the solubility in the intestine. The solubility of domperidone in 0.1N HCl and phosphate buffer pH 6.8, was evaluated with and without organic acids in fixed proportion. Among the different acids used, fumaric acid enhanced the solubility in basic dissolution media. Sustained release tablets of domperidone were prepared by using different grades of HPMC and eudragit polymers. Eight batches of tablets containing domperidone, polymers such as HPMC K4 M, HPMC K100 M, Eudragit R S-100, and Eudragit L-100 with and without fumaric acid to create micro environmental pH were prepared. In vitro dissolution study of tablets prepared with eudragit polymers exhibited distinguished release profile compared to HPMC polymers. The results indicated that the sustained release tablets of domperidone containing eudragit polymers released better in the basic region compared to HPMC polymers. The in vitro release data was treated with mathematical equations, and it was concluded that the drug release from the tablets followed Higuchi's diffusion mechanism from HPMC polymers and Korsmeyer's erosion and diffusion mechanism from Eudragit polymers.