Formulation and Evaluation of Fast Dissolving Oral Thin Film

Abstract

The objective of present work was to develop oral Fast dissolving film of montelukast sodium which was indicated for the prophylaxis and chronic treatment of asthma. This offers a solution for those patients having difficulty in swallowing tablets/capsules and allowing fast reproducible drug dissolution in oral cavity thus by passing first pass metabolism, to enhance the convenience and compliance by the elderly and pediatric patients. Montelukast oral fast dissolving oral thin films were prepared by solvent casting method with using different film-forming agents like pullulan gum, sodium CMC, PEG 400, glycerol as a plasticizer and mannitol as filler and sweetener. Oral films were evaluated for weight variation, thickness, surface pH, folding endurance, drug content, disintegration time and in-vitro dissolution studies. Montelukast oral films based on evaluation studies pullulan gum showed optimum performance against other formulations. The prepared films were clear, transparent and had a smooth surface. It was concluded that the fast dissolving oral thin films of montelukast can be made by solvent casting technique with enhanced dissolution rate, better patient compliance and effective therapy.