Design and Development of Fenofibrate Solid Dispersions for Solubility Enhancement

Abstract

This research work designed to overcome the problems associated with poorly aqueous soluble drug. Fenofibrate (FENO) being BCS Class
II drug shows low solubility but permeability is high. Compatibility of the drug and polymer studies was done by FTIR. Physical mixtures
(PM) of the drug and polymer HPMCAS were prepared by trituration method. Fenofibrate solid dispersions (SD) were prepared by common
solvent technique ascribed feasibility in laboratory scale. Physical state of formulations was characterized by powder XRD, TGA. Solubility
of pure drug (FENO), Physical mixture and SD found to be 0.3, 0.78±0.15 to 1.15±0.28 and 2.17±0.37 to 3.25±0.14 mg/ml respectively.
Percentage yield and percentage drug content were determined and found within satisfactory range. The maximum cumulative percentage
of drug release from pure drug (FENO), Physical mixture and SD found to be 34.5%, 72.1 and 97.2% respectively at 60 minutes. Microscopy
(SEM) study was found that the prepared solid dispersion has porous morphology. The present study establishes the increased bioavailability
of the optimized batch when compared with the pure FENO. There was significant (50%) increase in absorption of Fenofibrate observed
from the in vitro everted gut sac model. SD of FENO was developed successfully. The solubility of FENO was ameliorated significantly
while compared with API (pure FENO). This research work found formulation of SD preferable technique to enhance solubility and enhance
dissolution of lipophilic drugs.