Assessment of fenofibrate with a self-microemulsifying formulation in vitro and in vivo

OBJECTIVE To evaluate the dissolution behavior and the pharmacokinetics behavior of fenofibrate self-microemulsifying formulation in beagle dogs.METHODS The formulation was selected by drawing the ternary phase diagram and the particle sizes of resultant emulsions after self-emulsifying were determined.The plasma concentrations were determined by HPLC and the pharmacokinetics behavior of self-microemulsifying formulations was evaluated by comparison with the commercial product.RESULTS The dissolution of fenofibrate self-microemulsifying formulations at 20 min was much higher(more than 90%) than that of the commercial products(less than 10%).The area under time-concentration curve(AUC) was significantly higher(about 7 times) in fenofibrate self-microemulsifying formulation group than that in the commercial products.CONCLUSION The self-microemulsifying delivery systems can significantly increase fenofibrate's dissolution in vitro and absorption in vivo.