FORMULATION DEVELOPMENT AND EVALUATION OF FAST DISSOLVING ORAL FILM OF ATORVASTATIN CALCIUM

Fast dissolving oral films (FDOFs) are the most advanced form of oral solid dosage form due to more flexibility and comfort. It improve the efficacy of APIs by dissolving within minute in oral cavity after the contact with less saliva as compared to fast dissolving tablets, without chewing and no need of water for administration. Atorvastatin is a lipid lowering agent and widely used to treat hypercholestermia. However following oral administration, the bioavailability of the drug is only 12% due to extensive first pass metabolism. The aim of present work is to formulate and evaluate fast dissolving oral films of atorvastatin calcium 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), crospovidone (CP) 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 and 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 F4 was found to be best formulation which releases 98.95 % of the drug within 15 min and disintegration time is 168sec. which was significantly high when compared to other formulation. The results revealed that, atorvastatin fast dissolving oral films could be considered as promising drug delivery system for hyperlipidemic patients.

Keywords: Atorvastatin, Hypercholestermia, Fast dissolving films, Solvent casting method, Superdisintegrants.