FABRICATION AND EVALUATION OF MOUTH-DISSOLVING FILMS OF DOMPERIDONE

Abstract

Objective: The objective of present research work was to fabricate and evaluate mouth-dissolving films of domperidone by solvent casting method using hydroxypropyl methyl cellulose as polymer for rapid release of drug. Methods: Domperidone (DMP) is specific blocker of dopamine receptors (D2 and D3) and is widely used to treat emesis. Since domperidone solubility is less, domperidone solid dispersion (DMP SD’s) were prepared with β-cyclodextrine inclusion complexes in different ratio (1:1, 1:2, 1:3 and 1:4) by kneading method to increase the solubility. The DMP mouth dissolving films (MDF) were developed using DMP SD’s by solvent casting method. Hydroxypropyl methyl cellulose (HPMC) was used as film forming agent and glycerine was used as plasticizer. Nine formulations were fabricated and were evaluated for their various physico-mechanical properties, in vitro disintegration time and in vitro dissolution characteristics. Results: The solid dispersion SD3 increased the solubility of drug compared to pure drug. FTIR studies revealed the integrity of the drug in its pure form in both drug-βcyclodextrine complex and finished MDF. The thickness uniformity, weight uniformity, folding endurance, surface pH and drug content of mouth dissolving films were uniform and reproducible. Formulation F1 released highest percentage of drug i.e., 100% of drug in 16 min compared to other formulations in in vitro release studies and disintegrated within 2.5 min and hence was considered as optimized formulation. The mechanism of drug release of prepared mouth dissolving films was Non-Fickian diffusion controlled kinetics. Conclusion: Complexation by Kneading technique was found satisfactory for solid dispersion of domperidone. Solvent casting method was successfully used to obtain uniform mouth dissolving films containing drug-β cyclodextrine solid dispersion. Mouth dissolving films containing domperidone could be successfully developed and optimised.