ABSTRACT:
The objective of the current study was to develop and optimize an orodispersible tablet formulation of montelukast sodium which is an effective drug in the treatment of asthma and allergic disorders. Montelukast sodium is the drug used in treatment of ashthmatic and allergicrhinitis; it is selective leukotrienesreceptor antagonist. Orodispersible tablet is rapid dissolving or disintegrates without water within a few minutes in the oral cavity which may produce rapid onset of action due to the action of superdisintegrants. The orodispersible tablet were prepared by direct compression method using superdisintegrant agent such as croscarmilose sodium, crosspovidone and sodium starch glycolate. Six formulations of superdisintegrants having different concentration were prepared. After examine the angle of repose, bulk density, tapped density, Compressibility index and Hausner’s ratio of powder blend the results were found to be within prescribed limits and indicated good flowing property. The tablets were evaluated for hardness, drug content, friability, weight variation, wetting time and in vitro disintegration time and were found to be satisfactory. Among the formulations tablets of batch F3 and F6 containing co-processed disintegrating agents like croscarmilose: sodium starch glycolate (1:2) and crospovidone: croscarmiloss sodium (1:2) respectively showed superior organoleptic properties along with excellent in-vitro disintegration time and drug release as compare to other formulations. Hence crospovidone is recommended as suitable disintegrant for the preparation of direct compression mouth dissolving tablets of Montelukast sodium.