Preparation and Characterization of Ursodeoxycholic Acid Nanosuspension.

In the present research, the high pressure homogenization (HPH) technology was applied to prepare ursodeoxycholic acid (UDCA) nanosuspension. The aim of developing this new UDCA formulation was to enhance its bioavailability. The physicochemical characterization of UDCA nanosuspension was performed through particle size and Zeta potential measurements, differential scaning calorimetry (DSC) analysis, x-ray diffraction (XRD) measurements, and drug solubility and dissolution determinations. The mean particle size of UDCA nanosuspension was 297.5 nm with a polydispersity index of 0.162. Its particle size and Zeta potential did not show essential changes before and after water removal. The DSC curve of bulk UDCA showed a sharp endothermic peak at 207.82°C indicating the melting point. The XRD profile of dried powder of UDCA nanosuspension showed 2 intense peaks at 11.92° and 21.56°, respectively, indicating difference from the crystal characteristics of bulk UDCA. Its highest solubility and dissolution rate were 278.6 µg/mL and 98.77%, respectively. The feasibility of preparing nanosuspension by HPH technology was testified through successful preparation of UDCA nanosuspension. [ABSTRACT FROM AUTHOR]