Enhancement of Dissolution of Fenofibrate Using Complexation with Hydroxy Propyl β-Cyclodextrin

Abstract

The aim of the present study was to enhance the dissolution rate of fenofibrate using complexation with hydroxy propyl β-cyclodextrin (HPβCD). The phase solubility behavior of fenofibrate was studied in various concentrations of (HPβCD) aq. solution at 37°C. The solubility of fenofibrate increased with an increase in the amount of HPβCD aq. solution. Gibbs free energy (ΔG°)tr values were all negative. Complexes of fenofibrate with HPβCD were prepared in 1:1 ratio by kneading and coprecipitation. These complexes were evaluated by dissolution studies, fourier transform infrared (FTIR) spectroscopy, and differential scanning calorimetry (DSC) studies. The complexation of fenofibrate with HPβCD exhibited an enhanced dissolution rate. The mean dissolution time of fenofibrate decreased significantly upon complexation. FTIR studies showed the formation of intermolecular hydrogen bonding between fenofibrate and HPβCD. DSC studies indicated a loss in crystalline state of fenofibrate in complexes. Complexation with HPβCD can be used as a useful tool for the enhancement of dissolution of fenofibrate.