FORMULATION AND EVALUATION OF FAST DISSOLVING ORAL FILMS OF ANTI-EPILEPTIC DRUG
Dr. Roli Shukla
ABSTRACT
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. Clonazepam (CZ) is a benzodiazepine derivative with marked antiepileptic properties. It may be used in the treatment of all types of epilepsy and seizures. Thus the objective of the present study was to formulate and evaluate fast dissolving oral films of clonazepam to overcome the limitation of bioavailability 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.
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