Fixed Dose Formulation Development and Evaluation of Bilastine and Montelukast Sodium Tablets

Aim: The present research work was carried out to formulate stable fixed dose combination tablets of Bilastine and Montelukast Sodium, used to treat allergic rhinitis associated with asthma and rhino-conjunctivitis on basis of pre and post post-compression parameters evaluation and drug-drug-excipients compatibility studies.

Methods: Direct compression methodology was used for tablet production and final composition of drugs and excipients was optimized by evaluating pre and post compression evaluations of blend and tablets respectively. The chemical instability and stability studies were carried out using HPLC method.

Results: The Evaluation of pre-compression parameters of batch F1 to F5 shows that as we increase the amount of sodium starch glycolate and colloidal silicon dioxide from F1 to F5, bulk density and tapped density increases slightly whereas the compressibility index and hausner’s ratio of tablets was shifted from excellent to good. Angle of repose shows excellent flow property from F3-F5. After evaluation of post-compression parameters from F1 to F5, there is no significant difference in diameter, thickness and average weight of tablets. The hardness of tablets was decreased slightly from F1 to F5 therefore, the % friability was found to be increased from F1 to F5 and disintegration time was found to be decreased from F1 to F5. Dissolution studies shows % release of Bilastine and Montelukast was increased towards F1 to F5 as the percentage of Sodium Starch Glycolate increases. The drug-drug-excipients compatibility shows that there is no physical and chemical incompatibility between the drug-drug-excipients at accelerated conditions. The stability studies show that % assay of long term and accelerated samples are within 100±2%.

Conclusion: The optimized composition found in order to scale up the production of tablets.