FORMULATION AND EVALUATION OF BILAYER TABLET OF MONTELUKAST SODIUM AND DESLORATADINE IN THE TREATMENT OF ALLERGIC RHINITIS

B. Swaroopa*, Dr. A. Yasodha and K. Jyothi

ABSTRACT

The present study was aimed to develop bilayer tablets of montelukast sodium as SR layer and Desloratadine as IR layer to treat seasonal allergic rhinitis. The bilayer tablets were formulated by combining montelukast sodium with desloratadine which gives additional benefits in comparison with either drug alone and could be considered for patients whose quality of life, impaired by persistent allergic rhinitis. The tablets were formulated using hydrophilic polymers such as HPMC K4M and ethyl cellulose in varying ratios to retard the drug release for a period of 12 hours. The immediate release layer of Desloratadine was formulated using pregelatinzed starch (5% and 10 %). All the formulations were evaluated for physical characteristics, drug content, dissolution, release kinetics and stability studies. The Drug- excipient interaction was investigated with FTIR spectroscopy. The study indicated. The formulated granules were evaluated for precompression studies which showes that the flow property was good. The formulated tablets were found to be within the limits with respect to Weight variation, Hardness, Thickness and Friability. The friability of IR tablets containing pregelatinzed starch 10% was found to be optimum. Nine batches of montelukast sodium formulations containing varying proportions of HPMC K4M and ethyl cellulose were subjected to in vitro dissolution study of SR tablet, optimized formulation were selected using DOE software and selected for bilayer tablets. The optimized formulations of both montelukast sosdium and desloratadine were compressed into bilayer tablets. The drug content of the bilayer tablets were estimated by simultaneous estimation method and it was found to be within the Pharmacopoeial limits. The release kinetics of the optimized tablets showed that it follows zero order release kinetics. The stability studies indicated that the bilayer tablets were stable and do not show any significant changes in the physical characteristics, drug content and dissolution. The results obtained were found to be within the limits.

Keywords: Formulation, Evaluation, Bilayer Tablet, Montelukast Sodium, Desloratadine Allergic Rhinitis.