Background and Objective: Gastroesophageal reflux disease (GERD) is one of the most
common GIT disorders in which reflux of the GIT contents occurs into the esophagus. The present
study is focused on developing a dual component tablet containing a sustained release floating layer of
Baclofen and delayed release microspheres of Rabeprazole sodium for the effective treatment of Gastroesophageal
Reflux Disease (GERD).
Methods:Dual component tablets have been developed to achieve a controlled delivery of two different
drugs. Microspheres were prepared by the emulsion solvent evaporation method using different ratios
of Eudragit S100 and Rabeprazole sodium (3:1, 6:1, 9:1 and 12:1) and optimized using various parameters.
Baclofen floating tablets were prepared by the wet granulation method by using different polymers
like sodium alginate (S1), pectin (S2) and guar gum (S3) and characterized for their floating properties
and in-vitro drug release study.
Results: The cumulative percentage drug release after 9 hrs was found to be in the range of 46.18 to
65.78% for different microsphere formulations. The result showed that, as the amount of polymer increased,
the particle size and % yield were also increased, and drug release and entrapment efficiency
were decreased. Among all the formulations, M2 was considered as the best because it showed highest
entrapment efficiency. Among baclofen floating tablet formulations, S1 was resulted as optimized formulation
because it sustained the drug release up to 8 hrs and showed 64.82±0.82% drug release.
Conclusion: From the above optimized formulations bilayer tablets containing floating layer of Baclofen
and Rabeprazole sodium loaded microspheres layer were prepared by single-punch tablet machine
and evaluated for the weight variation, hardness, thickness, diameter, friability, floating time etc.
The results of the study showed that all parameters were within pharmacopoeial limits.