title: Application of Box-Behnken design in the preparation and optimization of fenofibrate-loaded self-microemulsifying drug delivery system (SMEDDS).
abstract: This study was designed to optimize a fenofibrate-loaded self-microemulsifying drug delivery system (SMEDDS) by using a response surface methodology. Box-Behnken design (BBD) and its desirability function were used to optimize the SMEDDS. The independent factors were the amounts of Labrafil M 1944 CS, Labrasol, and Capryol PGMC and the dependent variables were droplet size, cumulative percentage of drug released in 30 min and equilibrium solubility of fenofibrate in SMEDDS. Various response surface graphs were used to understand the effects of each factor, and the desirability function was then adjusted to optimize SMEDDS formulation. The experimental values of optimized formulation were in close agreement with predicted values. Furthermore, in vivo pharmacokinetic study of the optimized formulation showed significant increase in relative oral bioavailability compared to that of the powder suspension. In conclusion, the BBD demonstrated its effectiveness in optimizing the SMEDDS formulation and in identifying the effects of formulation variables.
authors.affiliation: College of Pharmacy, Yeungnam University , 214-1 Dae-Dong, Gyungsan, Gyungbuk 712-749 , South Korea and.
authors.forename: Dong Won
authors.initials: DW
authors.lastname: Lee
authors.forename: Nirmal
authors.initials: N
authors.lastname: Marasini
authors.forename: Bijay Kumar
authors.initials: BK
authors.lastname: Poudel
authors.forename: Jeong Hwan
authors.initials: JH
authors.lastname: Kim
authors.forename: Hyuk Jun
authors.initials: HJ
authors.lastname: Cho
authors.forename: Bo Kyung
authors.initials: BK
authors.lastname: Moon
authors.forename: Han-Gon
authors.initials: HG
authors.lastname: Choi
authors.forename: Chul Soon
authors.initials: CS
authors.lastname: Yong
authors.forename: Jong Oh
authors.initials: JO
authors.lastname: Kim
mesh_terms: D000818:Animals; D016503:Drug Delivery Systems; D004655:Emulsions; D011345:Fenofibrate / Q000737:chemistry / Q000493:pharmacokinetics / Q000494:pharmacology; D005989:Glycerides / Q000737:chemistry / Q000493:pharmacokinetics / Q000494:pharmacology; D000960:Hypolipidemic Agents / Q000737:chemistry / Q000493:pharmacokinetics / Q000494:pharmacology; D008297:Male; D009930:Organic Chemicals / Q000737:chemistry / Q000494:pharmacology; D011092:Polyethylene Glycols / Q000737:chemistry / Q000493:pharmacokinetics / Q000494:pharmacology; D011108:Polymers / Q000737:chemistry / Q000493:pharmacokinetics / Q000494:pharmacology; D011409:Propylene Glycols / Q000737:chemistry / Q000493:pharmacokinetics / Q000494:pharmacology; D051381:Rats; D017207:Rats, Sprague-Dawley
chemical_list: D004655:Emulsions; D005989:Glycerides; D000960:Hypolipidemic Agents; C514708:Labrafil M 1944 CS; D009930:Organic Chemicals; D011108:Polymers; D011409:Propylene Glycols; C584816:capryol propylene glycol monocaprylate; C440220:Labrasol; D011092:Polyethylene Glycols; D011345:Fenofibrate