Comparative in Vivo Evaluation of Delayed Release Pellets and Oral Solution Containing Fenofibric Acid

Fenofibrate is a third-generation fibric acid derivative indicated for the treartment of primary hyper-lipidemia or mixed dyslipidemia. Fenofibric acid delayed release (DR) pellets were successfully developed and optimized using wurster process. The present investigation aimed to evaluate the pharmacokinetic properties of Fenofibric acid DR pellets using rabbits as animal model. Blood samples were collected at various time intervals. The plasma concentration of Fenofibric acid was estimated by ultra-high performance liquid chromatography (UHPLC-UV) method. The pharmacokinetic parameters were calculated from the plasma concentration of Fenofibric acid vs. time profile. The sustained Tmax, lower Cmax and prolonged Mean residence time (MRT) indicate an delayed extended release of Fenofibric acid DR pellets compared to Fenofibric acid (as choline salt) API. From the obtained results, it is concluded that the test formulation was provided extend the delivery of Fenofibric acid in desired rate.