Formulation and Characterization of Bilastine Oral Disintegrated Tablets Using Natural and Synthetic Super Disintegrants

Bilastine (BLS) is a second-generation H1-antihistamine that is approved recently for the symptomatic treatment of chronic urticaria. The present investigation was to develop oral disintegrating tablets of BLS to produce a fast onset of action. In this study, an attempt was made to compare the effect of different natural and synthetic super disintegrants on the release profile of the formulation. The formulations (BF1-BF15) of BLS oral disintegrating tablets were prepared by direct compression technique using synthetic and natural super disintegrants (Chitosan, Fenugreek mucilage, Sodium starch glycolate, Ludiflash, Cross povidone) in three different concentrations (2, 4, and 6%). The formulated tablets were analyzed for pre-compression and post-compression parameters and in vitro drug release. The best formulation, F15 containing 6% Ludiflash as a super disintegrant, was found to have a maximum water absorption ratio and disintegration time and in vitro dissolution was found to be less than 5 min, ensuring faster disintegration and dispersion. The F15 formulation shows less disintegration and dispersion time because of its combined effect and formulation, which had a better drug release of 99.79% within 20 min. The dissolution pattern of various disintegrants used in the formulation was found to be in the order of Ludiflash>Cross povidone>chitosan>SSG>Fenugreek mucilage. Overall, the results show that the formulated oral disintegrating tablets of BLS with Ludiflash as a super disintegrant, indicating that this could be a feasible drug delivery for BLS.