Design and Statistical Optimization of Gastroretentive Drug Delivery System of Domperidone Maleate

The present study aims to formulatea gastroretentive drug delivery system of domperidone maleate using Methocel DC2 premium excipients for cost-effective manufacturing and desired release performance. An experimental design of nine formulations was developed using three factors at two levels with a centre point for the study. The effect of formulation variablesi.e., concentration of Methocel DC2 K100M, Methocel DC2 K4M and potassium bicarbonate on the floating lag time, drug release at the end of 2 hours, 8 hours, 10 hours and 15 hours were studied. The formulations were evaluated for weight variation, thickness, hardness, friability, total floating time, floating lag time and assay. All the formulated tablets were found to be floating with acceptable hardness. The concentration of Methocel DC2 K100M, Methocel DC2 K4M and Potassium bicarbonate was found to have an effect on floating lag time and drug release. Formulation FC5 was found to be optimised formulation. It was concluded from the study that gastroretentive floating tablet of domperidone maleate could serve as once-a-day formulation.