Abstract

DESIGN, FORMULATION AND CHARACTERIZATION OF MONTELUKAST SODIUM MOUTH DISSOLVING FILM

Rani D. Gupta, Anjali K. Gaidhane*, Ajit K. Khapne, Kamlesh J. Wadher and Milind J. Umekar

ABSTRACT

Oral mouth dissolving drug delivery system is considered to be a best alternative to the peroral route for the systemic administration of drugs, as it considered the most convenient, easy and safe route of administration. Mouth dissolving film may be preferred over the mouth dissolving tablets in terms of flexibility and comfort. The aim of this study is to formulate and characterize oral mouth dissolving film of Montelukast. Oral films were prepared by Solvent evaporation method using various concentrations (2%, 4% and 8%) of superdisintegrant like Crosscarmellose sodium, and Sodium starch Glycolate. Films were evaluated for mechanical properties, disintegration time, and in- vitro drug release. The film show acceptable weight variations as per pharmacopoeial specifications. Drug content estimation shows that more than 95% of the drug was present. The highest drug release was obtained with the formulation F9 containing higher concentration of superdisintegrants. Among the superdisintegrant, Sodium starch Glycolate showed rapid disintegration of the film than Crosscarmellose sodium.

Keywords: Mouth dissolving film, Montelukast, superdisintegrant, Solvent evaporation method.