Abstract

FORMULATION AND EVALUATION OF MANTELUKAST SODIUM CHEWABLE TABLET

Rajesh Kumar*, Prof. (Dr.) Pankaj Kumar Sharma, Prof. (Dr.) Jaya Sharma, Prof. (Dr). Rekha Kanwar, Dr. Monika Jain

ABSTRACT

Montelukast sodium is a selective leukotriene receptor antagonist widely used for the prophylaxis and chronic management of asthma and allergic rhinitis. The present study aimed to formulate and evaluate Montelukast sodium tablets with improved tablet performance, rapid drug release, and acceptable physicochemical characteristics. Tablets were prepared by the direct compression method using suitable excipients, including diluents, binders, superdisintegrants, lubricants, and glidants. Prior to compression, the powder blends were evaluated for pre-compression parameters such as angle of repose, bulk density, tapped density, Carr's index, and Hausner's ratio to ensure good flowability and compressibility. The compressed tablets were evaluated for post-compression parameters including appearance, thickness, hardness, weight variation, friability, drug content, disintegration time, wetting time (where applicable), and in-vitro dissolution. Stability studies were performed under accelerated storage conditions according to ICH guidelines to assess the stability of the optimized formulation. The optimized formulation demonstrated satisfactory mechanical strength, rapid disintegration, uniform drug content, and a high percentage of drug release within the specified time. Stability testing indicated no significant changes in the physical appearance, drug content, or dissolution profile during the study period. The findings suggest that the optimized Montelukast sodium tablet formulation possesses desirable quality attributes and provides efficient drug release, making it a promising oral dosage form for the effective management of asthma and allergic rhinitis with improved patient compliance.

Keywords: Montelukast Sodium, Tablet Formulation, Direct Compression, Superdisintegrant, In-vitro Dissolution, Stability Study, Quality Control, Oral Drug Delivery System.