Abstract
The main purpose of the present work was to develop matrix tablets of baclofen with hibiscus esculentus fruit mucilage and xanthan gum to study its functionality as a matrix forming agent for mucoadhesive sustained release tablet formulations. Various formulations of baclofen were prepared by wet granulation technique. The formulated tablets were tested for FTIR, DSC, hardness, friability, swelling behavior, in-vitro drug release, mucoadhesive strength and the dissolution data was treated with mathematical modeling and the optimized formulation was tested for accelerated stability studies. The formulated tablets were found to have good mechanical properties, good swelling properties. Based on in-vitro drug release pattern and ex-vivo mucoadhesive study; the formulation containing 23.5% w/w hibiscus mucilage and 5.5% w/w xanthan gum was found to be promising for mucoadhesion and sustained release. The in-vitro dissolution data was perfectly fitting to first order and the release of drug from the formulation followed higuchi’s release. The optimized tablet formulation was compared with marketed tablet formulation for drug release profiles. This formulation showed nearly similar drug release (t90% 9.1 hrs) compared to the marketed tablet formulation (t90% 9.7 hrs). The accelerated stability studies revealed that the tablets retain their characteristics even after stressed storage conditions. The results indicate the suitability of hibiscus esculentus mucilage for pharmaceutical use as a mucoadhesive agent. In conclusion, hibiscus esculentus can be used as an effective natural pharmaceutical excipient along with xanthan gum in the development of stable, gastro retentive sustained release mucoadhesive matrix tablets of baclofen.
