Enhancement of solubility and dissolution rate of Fenofibrate by melt granulation technique

This work describes a melt granulation technique to improve the solubility and dissolution characteristics of a poorly water-soluble drug Fenofibrate (FNO). Melt granulation technique is a process by which pharmaceutical powders are efficiently agglomerated by a meltable polymers and surfactants. The advantage of this technique compared to a conventional granulation is that no water or organic solvents is needed. Because of bypassing drying step, the process is less time consuming and uses less energy than wet granulation. Granules were prepared by using hydrophilic polymer PEG (polyethylene glycol-6000) and surfactant (poloxomers-407). The prepared granules were characterized using powder XRD, DSC and FTIR techniques. A significant enhancement in the solubility and vitro dissolution profiles of the melt granules was observed compared to the pure drug and drug excipient physical mixtures. DSC results indicated change in internal energy of FNO with polymer and surfactant in the melted granules. In conclusion, the results of this work suggest that melt granulation is a useful technique to enhance the solubility and dissolution rate of poorly water-soluble drug like, FNO.