Preparation study and bioavability evaluation of tablets containing fenofibrate nanoparticles

Abstract

The Fenofibrate tablet used was a high-tech dosage form, containing fenofibrate nanoparticles. Its advantage was a high bioavailability that was not affected by meal. This study aimed to prepare tablets containing fenofibrate nanoparticles with the same dose and bioavailability as the reference drug (Lipanthyl 145). The study developed a formula of nano fenofibrate suspension including fenofibrate 1,5g, HPC 0,05g, HPMC E6 0,025g, water 5g by wet ball milling. The suspension had a size less than 500nm and the ratio of fenofibrate was nano-sized to 70% after centrifuging at 100 rcf. Fenofibrate granules were made by fluid-bed granulation from milling suspension and fabricated tablet containing 145 mg of fenofibrate. The tablet had dissolution similar to the reference drug. The oral bioavailability of the studied tablets was compared to the reference drug in drugs according to the model of double crossover principle, two doses, two drugs, two periods, two sequences. The results of AUC_last (µg*h/mL), C_max (µg/mL), T_max (h) of the studied tablet and reference drug were (45.473; 5.899; 2.625) and (46.019; 5.814; 2.583) respectively. This result showed that preparing nano fenofibrate-containing dosage form equivalent to the reference drug was feasible.