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...

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Bibliographic Details
Published in:Journal of microencapsulation 2014-01, Vol.31 (1), p.31-40
Main Authors: Lee, Dong Won, Marasini, Nirmal, Poudel, Bijay Kumar, Kim, Jeong Hwan, Cho, Hyuk Jun, Moon, Bo Kyung, Choi, Han-Gon, Yong, Chul Soon, Kim, Jong Oh
Format: Article
Language:English
Subjects:
Animals
Box-Behnken design
desirability function
Drug Delivery Systems
Emulsions
fenofibrate
Fenofibrate - chemistry
Fenofibrate - pharmacokinetics
Fenofibrate - pharmacology
Glycerides - chemistry
Glycerides - pharmacokinetics
Glycerides - pharmacology
Hypolipidemic Agents - chemistry
Hypolipidemic Agents - pharmacokinetics
Hypolipidemic Agents - pharmacology
Male
optimization
Organic Chemicals - chemistry
Organic Chemicals - pharmacology
Polyethylene Glycols - chemistry
Polyethylene Glycols - pharmacokinetics
Polyethylene Glycols - pharmacology
Polymers - chemistry
Polymers - pharmacokinetics
Polymers - pharmacology
Propylene Glycols - chemistry
Propylene Glycols - pharmacokinetics
Propylene Glycols - pharmacology
Rats
Rats, Sprague-Dawley
SMEDDS
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Summary: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.
ISSN:0265-2048
1464-5246
DOI:10.3109/02652048.2013.805837