DESIGN AND EVALUATION OF FAST DISSOLVING FILM OF DOMPERIDONE

Abstract

The objective of present research work was formulation and development fast dissolving film of domperidone. Domperidone is a specific blocker of dopamine receptors Solvent casting method was used for preparation of fast dissolving film. Various film forming polymers were evaluated for selection of suitable polymer. Different polymers like maltodextrin, polyvinyl alcohol and different grades of hydroxypropyl methylcellulose like HPMC E5 LV, HPMC E15 LV and HPMC E3 LV were used in study for selection of polymers. Amongst them HPMC E3 LV, HPMC E5 LV was selected as film forming polymer and propylene glycol was used as plasticizer. For solubility enhancement inclusion complex from $\beta#$-cyclodextine was prepared by kneading method. Films were evaluated for physical and mechanical properties, drug content, disintegration time, in vitro dissolution and stability study. Prepared films showed satisfactory physical and mechanical properties. Drug excepients interaction study (IR spectroscopy), Differential scanning calorimetry (DSC), Drug content, disintegration time and in vitro dissolution were also acceptable. 3² factorial design were used for optimization of film formulation. Batch F4 was found to be optimized film formulation which has 35.33 second disintegration tie, tensile strength 2.180 N/cm, drug release 75.26% after 15 min. Acelerated stability studies on the promising formulations indicated that there were no significant changes in drug content, in vitro disintegration time, tensile strength, in vitro dissolution and surface pH.