The objective of present work is to formulation and evaluation of bilayers Tablets of montelukast sodium immediate release and bilastine sustained release for treating allergic rhinitis effectively. The combining Montelukast with bilastine gives additional benefits. The tablet formulating Montelukast in immediate release layer and bilastine as sustained release layer as it improves and increases the stability by reducing the acid base interactions of both the drugs in combination, increasing the bioavailability. In this research many polymers used but natural polymer pectin is used as a release retardant for sustained release layer. The formulations were evaluated for hardness, weight variation, friability, and drug content uniformity. The in vitro release of drug from the formulations was studied in pH 1.2 acidic buffers and pH 7.4 phosphate buffer, and it was found that the prepared tablets were able to sustain the release of the drug upto 12hours. The release of Montelukast and bilastine of both layers from the tablets was found to be diffusion controlled and the release mechanism was non-Fickian based on the n value of Korsmeyerpeppas plot. The FTIR studies were performed on three optimized formulations (F5) and the plain drug controls(Bilastine ,Montelukast). From the observed peaks it is evident that the polymers used and the drugs were found to be mutually compatible chemically. The dissolution results indicate that the formulation optimised with pectin was able to sustain the release of bilastine upto 12hours. So that the studies indicating efficient sustained action and improved bioavailability of the drug. The formulated bilayered tablets using natural polymers provided immediate release of montelukast and sustained release of bilastine and therefore hold promise as an alternative dosage form in the treatment of allergic rhinitis, urticaria and bronchial asthma.

Allergic Rhinitis, Urticaria, Montelukast sodium, Bilastine