Formulation, Development and Evaluation of Fast Dissolving Oral Film of Antipsychotic Drug

Abstract

In case of psychiatric treatment immediate release of drug from the dosage form is required. Fast dissolving dosage forms are gaining popularity in recent time, as this dosage forms requires no water for administration. Oral films dissolve rapidly along with drug in mouth and majority of the drug is absorbed through buccal/oral mucosa in to systemic circulation avoiding first pass metabolism. Olanzapine is a thienobenzodiazepine class of drugs, which has been approved by the FDA, for the treatment of schizophrenia, depressive episodes associated with bipolar disorder, acute manic episodes and maintenance treatment in bipolar disorder. The absolute bioavailability is only approximately 31.5% due to extensive hepatic metabolism. Thus the objective of the present study was to formulate and evaluate fast dissolving oral films of Olanzapine 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. Among all, the formulation F4 was found to be best formulation which releases 98.78 % of the drug within 15 min and disintegration time is 42 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 F4 was maximum i.e 0.974 hence indicating drug release from formulations was found to follow first order drug release kinetics.