Abstract
The aim of this study is to improve the in vitro dissolution rate of bosentan monohydrate, a water insoluble drug belongs to BCS class II. For enhancing the solubility we want to fabricate solid dispersion of bosentan monohydrate with water soluble polymers by Hot Melt Extrusion Technique. In the present study we fabricated solid dispersion of bosentan monohydrate using soluplus as a polymer at different ratios. The prepared solid dispersion were characterized by differential scanning calorimetry, X-ray diffraction, fourier transform infrared spectroscopy and invitro dissolution. From the studies performed we concluded that bosentan monohydrate was a crystalline API and it was successfully converted to amorphous form and there is no major interactions between the functional moieties of drug molecule with excipients incorporated in the formulation of solid dispersions. The rate and extent of drug release of batches fabricated with solid dispersions was much better when compared with batch fabricated with bosentan mohydrate API (F6). For enhancing the solubility and the dissolution rate and extent of API, solid dispersion process is a good approach. For fabricating stable solid dispersion hot melt extrusion is an efficient process with good industrial applicability. From the present research work the rate and extent of dissolution data of batches fabricated with solid dispersion (F1, F2, F3 & F4) was much better when compared with the batch fabricated with API (F6.) Batch (F2) was further evaluated in different dissolution mediums and found that rate and extent of drug release was much better when compared with the (F6) in all the dissolution mediums. Overall, hot melt was an efficient strategy to enhance the dissolution rate.
