DEVELOPMENT OF STABLE DISPERSABLE BI-LAYER TABLET OF MONTELUKAST SODIUM AND LEVOCETRIZINE HCL

In the present study an attempt was made to prepare bilayer tablet of Montelukast sodium and Levocetrizine HCL for the treatment of asthma and allergic rhinitis. Bilayer tablet of Montelukast Sodium and Levocetrizine HCL was successfully developed. Immediate release of Montelukast was formulated with crosscaramellose sodium and Levocetrizine layer with starch granules as disintegration. IR spectrum revealed that there is no disturbance in the principle peaks of pure drugs of Montelukast sodium and Levocetrizine HCL. This indicates there was no interaction between the drug and excipient.The formulation showed good flow property and compressibility index. The angle of repose was ranged from 25.0˚±1.40 to 31.4˚±0.97 for Montelukast sodium and 25.2˚±1.40 to 29.5˚± 0.68 for Levocetrizine HCL. The compressibility index was found range from 11.6 to 22.2 for Montelukast sodium and 14.1 to 27.8 Levocetrizine HCL. Hausner’s ratio was found to be 1.143 to 1.287 for Montelukast sodium and 14.1 to 27.8 for Levocetrizine HCL. The result of the angle of repose indicates good flow property of the granules and the values of compressibility index further showed support for the flow property. The prepared tablets were evaluated for hardness, friability, weight variation, drug content uniformity. The results were found within the limits. Among the various formulations prepared, Formulation F8 with croscarmellose sodium (20%) shows minimum disintegration time and improved dissolution properties compared to formulation F-1 to F-7. This is because of the dual action of wicking and swelling property of disintegrants. The stability studies were carried out for the optimized formula for three months and it show acceptable results. Hence, Montelukast sodium and Levocetrizine HCL bilayer tablets can be used for alternative dosage form in the effective treatment of patients suffering from allergic rhinitis and bronchial asthma.