European Journal of Biomedical and Pharmaceutical Sciences

FORMULATION AND IN-VITRO EVALUATION OF ORALLY-DISSOLVING MONTELUKAST SODIUM THIN FILM

Akelesh T*, Nimisha MP, Sam Johnson Udaya Chander J, Venkatanarayanan R, Senthil Kumar C

ABSTRACT

Montelukast sodium is a leukotriene receptor antagonist (LTRA) is indicated for the prophylactic therapy of mild-to-moderate asthma and to relieve symptoms of seasonal allergies. The oral thin film is a dosage form which, when placed in the oral cavity, quickly gets hydrated and then disintegrates to release the drug. The purpose of the present study is to formulate oral thin film of Montelukast sodium by solvent casting method using hydrophilic polymers like HPMC, methyl cellulose and sodium CMC with PEG400 as plasticizer. Mannitol was used as the sweetening agent and it also helps in disintegration. Menthol used as the flavouring agent. The compatibility of the drug in the formulation was confirmed by FT-IR studies. By varying concentration of polymers, nine formulations (F1-F9) were formulated. The prepared oral thin films were evaluated for physical appearance, weight variation, thickness, surface pH, folding endurance, drug content, moisture absorption, disintegration time and in-vitro dissolution studies. The prepared films were clear, transparent and had smooth surface. In-vitro dissolution studies revealed higher drug release from formulation F7, releases 98.94% at the end of 300 seconds and considered as the best formulation. The stability studies were carried out, which does not show any significant changes after three months.

Keywords: Oral thin film, Montelukast Sodium, HPMC, Sodium CMC, Methyl cellulose, Solvent casting.