Formulation design of bilayer dual-release tablet composition of fexofenadine HCl and montelukast sodium

The purpose of this study was to develop dual-release bilayer tablets of fexofenadine HCl and montelukast sodium (MKS) to treat the individuals getting symptoms of asthma and allergic rhinitis at late night and early morning which may lead to breathing and respiratory problem. The bilayer tablet was designed to contain fexofenadine for the immediate release and MKS for the extended release matrix. MKS and fexofenadine tablets were prepared separately by direct compression method. The optimized tablets were compressed to obtain bilayer tablets. The tablets were evaluated for various physicochemical parameters and dissolution study. Further, the bilayer tablets were subjected to accelerated stability study. The fexofenadine tablet showing more than 75% release in 15 min and MKS tablet showing more than 90% release at the end of 7 h with 2 h of initial lag time were compressed one above the other to obtain bilayer tablet. The similar release pattern was observed with the bilayer tablets as that of individual tablets. The bilayer tablets were found to be stable at the end of 6 months storage period as per ICH guidelines. Both the layers of the bilayer formulation showed desired drug release at the end of time period, these could be effective formulations in late night and early morning symptoms of asthma and allergic rhinitis.