FORMULATION AND EVALUATION OF BILAYER TABLETS OF DOXOFYLLINE HCl AND MONTELUKAST SODIUM

In the present study, an attempt was made to reduce the dosing frequency and thus improve patient compliance by formulating bilayer tablets containing doxofylline HCl as sustained release (SR) layer and montelukast sodium as immediate release (IR) layer. The sustained release layer of doxofylline HCl was developed by wet granulation technique using polymers HPMC K100M and eudragit RL100 and the immediate release layer of montelukast sodium by direct compression method using superdisintegrant crosscarmellose sodium. The tablets were evaluated for their physical parameters. All the values were found to be within acceptable limits. The in vitro release was carried out using USP Type II apparatus. Out of all the formulations, DF4ML4 was found to be optimum producing an immediate release of 99.41 ± 0.43 % within 45 min followed by sustained effect of 98.60 ± 0.73 % release upto 13 h. The optimized batch was subjected to stability studies for 6 months at 40 ˚C ± 2 ˚C/ 75 % RH ± 5 % RH. The results suggested that the developed bilayer tablets can be used as an alternative to the conventional dosage form