FABRICATION AND CHARACTERIZATION OF ORAL THIN FILMS OF LEUKOTRINE RECEPTOR ANTAGONIST (LTRA)

Abstract

Montelukast sodium is a leukotriene receptor antagonist (LTRA) used in maintenance treatment of asthma and to relieve symptoms of seasonal allergies. Fast dissolving drug delivery system offers a way out for those patients having difficulty in swallowing tablets/capsules etc. The present exploration was undertaken with the intention of formulating of the montelukast sodium fast dissolving oral thin films allowing fast reproducible drug dissolution in oral cavity thus bypassing first pass metabolism, to augment the expediency and acquiescence by the elderly and pediatric patients. Montelukast fast dissolving oral thin films were equipped by solvent casting method with using diverse film-forming agents like HPMC, PVP, PEG 400, glycerol as a plasticizer and mannitol as filler and sweetener. Oral thin films were characterized for weight variation, thickness, surface pH, folding endurance, drug content, disintegration time, drug polymer compatibility (IR Study and in-vitro dissolution studies. Montelukast oral thin films based on evaluation studies HPMC showed optimum performance against other formulations. The prepared films were clear, transparent, and had a smooth surface. The surface pH was found to be in the range of 6.31 to 6.75 which is close to salivary pH, which indicates that films may have less potential to irritate the oral mucosa, thereby they are comfortable. The drug content of all the films was in the range of 96.80 to 99.12 suggesting that drug was uniformly dispersed throughout all films. The In-vitro disintegration time of films prepared with HPMC was in the range of 25.38 to 39.12 sec. As the concentration of SSG increases the in-vitro disintegration time of the films decreases. It was accomplished that the fast dissolving oral thin films of montelukast can be prepared by solvent casting technique with improved dissolution rate, better patient compliance and effective therapy.