Mucoadhesive buccal tablets of domperidone: formulation evaluation and effects of process variables

Abstract

The aim of the present work was to develop and evaluate buccal adhesive tablets of domperidone and study the effect of diluents. Tablets were prepared by direct compression method using different polymer and excipients combinations. Formulations batches were evaluated for physical parameter, swelling studies, bioadhesion studies and in vitro drug release. Formulation batch F2 was most promising composition of 1:5 ratio of HPMC K4 M/Sodium alginate. Effect of formulation variables such as diluents i.e. lactose (water soluble) and di-calcium phosphate (DCP) (water insoluble) studied on swelling index, bioadhesive performance and in vitro drug release. Bioadhesive force was drastically decreased in presence of DCP; it was concluded that DCP more significantly affected the swelling index than did lactose. Both Lactose and DCP similarly affect the bioadhesive strength of buccal adhesive tablets. Dissolution profiles have shown non-fickian drug release mechanism, which indicated that the drug was released by diffusion and erosion mechanism. Thereby buccal adhesive tablets offer a promising strategy for drug delivery of domperidone.