Abstract

FORMULATION DEVELOPMENT AND IN VITRO EVALUATION OF ORAL DISPERSIBLE TABLETS OF BILASTINE AND MONTELUKAST

Shalini Yadav* and Amit Jain

Abstract

Mouth dissolving tablet enriched with taste masking agent to provide rapid onset of action of montelukast and bilastine increasing their therapeutic efficacy and also increasing the compliance amongst geriatric, pediatric and uncooperative patients was formulated. The integrity of the drug samples was confirmed by physical characterization, melting point, solubility. Precompression blends of the MDTs were prepared and evaluated for its micromeritic properties. The angle of repose, bulk and tapped density, Hausner’s ratio and Carr’s Index were determined and all indicated that the prepared blends have excellent flow characteristics. Total four formulations of MDTs were prepared using direct compression method. The concentration of the superdisintegrant (crospovidone) was varied depending on the method. Mannitol was used as the binder as well as sweetener while saccharin sodium was used as the additional taste masking agent in the formulations. All the formulations were subjected to post compression evaluation test and the results indicate that the formulation had hardness of 4 Kg/cm2, thickness of around 8 mm, weight variation in the range of 2.7-5.3 %, friability of less than 1 %, drug content in the range of 96.75 to 98.60 % for montelukast and 97.20 to 98.90 % for bilastine, wetting time from 19 to 39 seconds with water absorption ratio of more than 75 %, disintegration time of less than 30 seconds and a drug release of more than 80 % over a period of 5 minutes.

Keywords: Mouth Dissolving Tablet, Montelukast, Bilastine, Oral Dispersal Tablets.