FORMULATION DEVELOPMENT AND EVALUATION OF FAST DISSOLVING ORAL FILM OF DOLASETRON MESYLATE

The aim of present work is to formulate and evaluate fast dissolving oral films of dolasetron mesylate to improve water solubility, dissolution rate, oral bioavailability and reduction of first pass metabolism and increase patient’s compliance. Oral fast dissolving films prepared by solvent casting method using water and 95% ethanol as solvents and HPMC as film forming polymer. PEG 400 was the selected plasticizers, Superdisintegrants such as croscarmellose sodium (CCS) and sodium starch glycolate (SSG) alone and also in combinations was incorporated to achieve the aim. The prepared films were evaluated for the drug content, weight variation, film thickness, disintegration time, folding endurance, percentage of moisture content and in vitro dissolution studies and taste mask studies on healthy human volunteers. Among all, the formulation F3 was found to be best formulation which releases 99.12% of the drug within 15 min and disintegration time is 47±7 sec. which was significantly high when compared to other formulation. The data obtained from In-vitro release were fitted into the various kinetic models such as Zero Order, Higuchi, First Order and Korsmeyer–Peppas model in order to determine the mechanism of drug release. When the regression coefficient values compared, it was observed that ‘r’ values of formulation F3 was maximum i.e 0.951hence indicating drug release from formulations was found to follow first order drug release kinetics.