Volume :
3
Issue :
1
Abstract :
This research work describes the formulation of bilayer tablets of doxofylline HCl and montelukast sodium as sustained release (SR) and immediate release (IR) layer respectively. The aim was to reduce the dose and dosing frequency and thus improve patient compliance in the treatment of asthma. Hydrophilic polymers like hydroxypropyl methylcellulose (HPMC) K15M and carbopol 934P and polyvinyl pyrrolidone (PVP) K30 as binder were used to prepare the sustained release layer by wet granulation technique and crosscarmellose sodium was used as superdisintegrant in the formulation of immediate release layer. The tablets were evaluated for their hardness, friability, drug content, disintegration and dissolution. The dissolution study of SR layer revealed that an increasing concentration of polymers results in decreased doxofylline release. The optimized formulation showed an immediate complete release of montelukast sodium within 45 min and a sustained doxofylline HCl release upto 13 h. The stability study results also complied with the International Conference on Harmonization (ICH) guidelines. From this study it was concluded that the developed bilayer tablets can be an effective alternative dosage form for asthmatics.