ABSTRACT
OBJECTIVE: To study the effect of water-soluble materials on the inclusion complex of fenofibrate and hydroxypropyl-β-cyclodextrin. METHODS: The inclusion complex of fenofibrate/hydroxypropyl-β-cyclodextrin and the ternary system containing water-soluble materials were obtained by ball milling. The inclusion complex was characterized by differential scanning calorimetry (DSC), powder X-ray diffractometry (XRD), Fourier-transformed infrared spectrophotometry (FTIR), 1H-NMR spectroscopy, as well as in vitro dissolution and stability test. RESULTS: The stability tests and in vitro dissolution results showed that the addition of water-soluble materials could improve the stability constant and inclusion efficiency of the inclusion complex. Moreover, the addition of hydroxypropyl methylcellulose(HPMC) could result in a more stable complex and the in vitro dissolution rate of complex was also increased. CONCLUSION: The addition of appropriate water-soluble materials could enhance the inclusion efficiency of hydroxypropyl-β-cyclodextrin with drugs and form a more stable system.