Abstract

FORMULATION AND DEVELOPMENT OF BILASTINE TABLETS 20MG

*Kandukuri Rekha, R. Aruna, Dr. Rinku Mathappan, Dr. Mekkanti Manasa Rekha, S. Karthik

Abstract

Bilastine is a new second generation H1-antihistamine approved forthe symptomatic treatment of allergic rhinitis (AR) and chronicurticaria (CU). Bilastine, with its efficacy and safety profile epitomizesthe evolution of research on antihistamines Bilastine works byblocking histamine receptors. Fast dissolving tablets of Bilastine wereprepared using Mannitol Dc grade, sodium starch glycolate andCrosspovidone as superdisintegrants and Colloidal silica, Talc,Magnesium stearate by direct compression method. The tabletsprepared were evaluated for various parameters like weight variations,hardness, friability, in vitro dispersion time, drug content, wetting time,in vitro drug release. The tablets prepared by direct compressionmethod possess a weight variation below ±7.5%, hardness of 3 to 4.0 Kg/cm², percentagefriability of 0.85, in vitro dispersion time of 10 secs, Wetting time of 10 seconds, and in vitrodrug release showed 94% to 99.00% within 15 min. The formulation contains Crosspovidoneand Sodium Starch Glycolate shows better Disintegration time and 99% drug release within20 min. Bilastine tablets compare with marketed product physical parameters and dissolutiion parameters are shows similar results to the formulated tablets based on physical and chemical paramed optimised our formula with marketed product of bilastine tablets 20 mg.

Keywords: Mannitol Dc grade, Microcrystalline Cellulose, Sodium Starch glycolate type A (derived from potato), Colloidal silica anhydrous, Cross povidone, Talc and Magnesium Stearate.