Abstract:
OBJECTIVE To explore the preparation and in vitro and in vivo experiments of mesoporous silica nanoparticles(HK) solubilizing fenofibrate(FNB) tablets. METHODS HK was used as a carrier for FNB to make the solid dispersion(FNB-HK) with the method of adsorption. The existing state of fenofibrate in FNB-HK was analyzed by differential scanning calorimetry, X-ray diffraction and Fourier transform infrared spectroscopy. The dissolution experiment in vitro was conducted to optimize the formulation. Rabbits were administrated with the self-made tablets made according to the optimized formulation and commercial tablets in a single oral dose. The concentration of the rabbits’ plasma were determined by HPLC. RESULTS The characterization of FNB-HK showed that HK inhibited the crystallization of fenofibrate. Through optimizing formulation, the dissolution rate of tablets achieved an ideal state by using lactose as filler and 8% sodium carboxymethyl starch as a disintegrating agent. Compared with commercial tablets, the peak time of the self-made tablets advanced, and the peak concentration increased. The relative bioavailability was 149.95%. CONCLUSION This preparation of tablets can significantly improve the dissolution rate of FNB and improve the oral bioavailability.