Formulation Evaluation of Mouth Dissolving Tablets of Fenofibrate Using Sublimation Technique

Fenofibrate is a drug of the fibrate class. It is a widely used hypolipidemic drug. The poor aqueous solubility of the drug leads to variable dissolution rates. It is slightly soluble in water. The present investigation was to develop and characterize mouth dissolving tablets of fenofibrate using sublimation technique. Mouth dissolving tablets of Fenofibrate were prepared using different subliming agents like camphor, thymol, ammonium bicarbonate and different concentrations of menthol using direct compression method. The technique is to increase the porosity of the tablets whereby subliming material was sublimed from the granules by exposing the granules to vacuum. The porous granules were then compressed in to tablets. Alternatively, tablets were first prepared and later exposed to vacuum. Since, these tablets can be swallowed in the form of dispersion; it is suitable dosage form for pediatric and geriatric patients. The drug and excipients were characterized using DSC and FTIR techniques. The blend was examined for angle of repose, bulk density, tapped density, compressibility index and Hausner’s ratio. The prepared tablets were evaluated for general appearance, content uniformity, hardness, friability, taste evaluation, mouth feel, wetting time, in vitro and in vivo disintegration time, and in vitro dissolution studies. Tablets with menthol at 12.5% concentration have shown quick disintegrating features, i.e., within 20 s, which is very characteristic of orodispersible tablets. The in vitro drug release study revealed that menthol at a concentration of 12.5 % (F10) of the dosage form weight was able to fast the release of Fenofibrate within 10 minutes. These compressed tablets which have 12.5 % menthol (F10) rapidly dissolved within 22 seconds in saliva in the mouth. Further optimized formulations (F10) were subjected to stability testing for 3 months at temperatures 25±5oC/60±5%RH and 40±5oC/75±5%RH. Optimized tablets have shown no appreciable changes with respect to taste, disintegration, and dissolution profiles. In conclusion, the results of this work suggest that sublimation is a useful technique to enhance the solubility and dissolution rate of poorly water-soluble drug like fenofibrate.