Formulation and Evaluation of Montelukast Sodium Fast Dissolving Tablets

Abstract

Montelukast sodium is an anti-asthmatic drug mainly prevents leukotriene mediated effect associated with asthma. Mouth dissolving tablets of montelukast sodium was prepared by direct compression method using super disintegrants such as cross carmellose sodium, crosspovidone and sodium starch glycolate. Mouth dissolving tablets (MDTs) disintegrates or dissolves rapidly without water within few seconds in the mouth due to the action of superdisintegrants or maximizing pore structure in the formulation. The tablets were prepared using various diluents like MCC, Lactose and superdisintegrants namely Crosscarmellose sodium, Crosspovidone and Sodium starch glycollate in different concentrations. Pre-compression parameters such as angle of repose, bulk density, tapped density, compressibility index, Hausner’s ratio were carried out to study the flow properties of powder to achieve uniformity of tablet weight and the values were within permissible limits. Theprepared tablets were evaluated for hardness, thickness, weight variation, friability, % drug content, wetting time, water absorption ratio, in vitro disintegration time, in vitro dispersion time and in vitro drug release. Theformulation F5 was found to be the best on the basis of wetting time, in vitro disintegration time and in vitro drug release. Stability studies were carried out at 250C ± 20C / 60% ± 5% RH and 400C ± 20C / 75% ± 5% RH for a period of 60 days for the selected formulations. The formulation F5 containing Crospovidone (8%) as super disintegrant and microcrystalline cellulose and lactose as diluents was respectively found to be the optimized combination.