Design, optimization and evaluation of domperidone coevaporates.

Coevaporates of domperidone were prepared using different polymers by solvent evaporation technique. Ethyl cellulose and hydroxypropyl methylcellulose phthalate were used in preparation of coevaporates. The coevaporates were characterized by X-ray diffraction studies, IR spectrophotometry and differential scanning calorimetry. The dissolution behavior of coevaporates was studied using buffer solution of pH 1.2 for the first 2 h and that of pH 6.8 thereafter up to 12 h. A two-factor, three-level design was used to quantitate the effect of polymers on dissolution profile of domperidone. The drug release rate was found to be dependent on the concentration of polymers in the coevaporates. Dissolution of drug in a pH 6.8 buffer improved with increasing concentration of hydroxypropyl methylcellulose phthalate in coevaporates. Bioavailability studies in human volunteers confirmed that domperidone coevaporates sustained drug release.