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Preparation and in vivo evaluation of SMEDDS (self-microemulsifying drug delivery system) containing fenofibrate

Ashok Patel UGent and Pradeep R Vavia (2007) AAPS JOURNAL. 9(3). p.E344-E352
abstract
The present work was aimed at formulating a SMEDDS ( selfmicroemulsifying drug delivery system) of fenofibrate and evaluating its in vitro and in vivo potential. The solubility of fenofibrate was determined in various vehicles. Pseudoternary phase diagrams were used to evaluate the microemulsification existence area, and the release rate of fenofibrate was investigated using an in vitro dissolution test. SMEDDS formulations were tested for microemulsifying properties, and the resultant microemulsions were evaluated for clarity, precipitation, and particle size distribution. Formulation development and screening was done based on results obtained from phase diagrams and characteristics of resultant microemulsions. The optimized formulation for in vitro dissolution and pharmacodynamic studies was composed of Labrafac CM10 (31.5%), Tween 80 (47.3%), and polyethylene glycol 400 (12.7%). The SMEDDS formulation showed complete release in 15 minutes as compared with the plain drug, which showed a limited dissolution rate. Comparative pharmacodynamic evaluation was investigated in terms of lipid-lowering efficacy, using a Triton-induced hypercholesterolemia model in rats. The SMEDDS formulation significantly reduced serum lipid levels in phases I and II of the Triton test, as compared with plain fenofibrate. The optimized formulation was then subjected to stability studies as per International Conference on Harmonization (ICH) guidelines and was found to be stable over 12 months. Thus, the study confirmed that the SMEDDS formulation can be used as a possible alternative to traditional oral formulations of fenofibrate to improve its bioavailability.
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (review)
publication status
published
subject
keyword
SMEDDS, fenofibrate, pseudoternary phase diagrams, triton-induced hyperlipidemia, BIOAVAILABILITY ASSESSMENT, ORAL ABSORPTION, FORMULATION, RATS, SOLUBILIZATION, DISSOLUTION, GLYCERIDES, MIXTURES, SEDDS, MODEL
journal title
AAPS JOURNAL
AAPS J.
volume
9
issue
3
pages
E344 - E352
Web of Science type
Review
Web of Science id
000251535700011
JCR category
PHARMACOLOGY & PHARMACY
JCR impact factor
3.756 (2007)
JCR rank
42/204 (2007)
JCR quartile
1 (2007)
ISSN
1550-7416
DOI
10.1208/aapsj0903041
language
English
UGent publication?
no
classification
A1
copyright statement
I have transferred the copyright for this publication to the publisher
id
3007980
handle
http://hdl.handle.net/1854/LU-3007980
date created
2012-10-05 23:09:46
date last changed
2012-10-09 15:43:36
@article{3007980,
  abstract     = {The present work was aimed at formulating a SMEDDS ( selfmicroemulsifying drug delivery system) of fenofibrate and evaluating its in vitro and in vivo potential. The solubility of fenofibrate was determined in various vehicles. Pseudoternary phase diagrams were used to evaluate the microemulsification existence area, and the release rate of fenofibrate was investigated using an in vitro dissolution test. SMEDDS formulations were tested for microemulsifying properties, and the resultant microemulsions were evaluated for clarity, precipitation, and particle size distribution. Formulation development and screening was done based on results obtained from phase diagrams and characteristics of resultant microemulsions. The optimized formulation for in vitro dissolution and pharmacodynamic studies was composed of Labrafac CM10 (31.5\%), Tween 80 (47.3\%), and polyethylene glycol 400 (12.7\%). The SMEDDS formulation showed complete release in 15 minutes as compared with the plain drug, which showed a limited dissolution rate. Comparative pharmacodynamic evaluation was investigated in terms of lipid-lowering efficacy, using a Triton-induced hypercholesterolemia model in rats. The SMEDDS formulation significantly reduced serum lipid levels in phases I and II of the Triton test, as compared with plain fenofibrate. The optimized formulation was then subjected to stability studies as per International Conference on Harmonization (ICH) guidelines and was found to be stable over 12 months. Thus, the study confirmed that the SMEDDS formulation can be used as a possible alternative to traditional oral formulations of fenofibrate to improve its bioavailability.},
  author       = {Patel, Ashok and Vavia, Pradeep R},
  issn         = {1550-7416},
  journal      = {AAPS JOURNAL},
  keyword      = {SMEDDS,fenofibrate,pseudoternary phase diagrams,triton-induced hyperlipidemia,BIOAVAILABILITY ASSESSMENT,ORAL ABSORPTION,FORMULATION,RATS,SOLUBILIZATION,DISSOLUTION,GLYCERIDES,MIXTURES,SEDDS,MODEL},
  language     = {eng},
  number       = {3},
  pages        = {E344--E352},
  title        = {Preparation and in vivo evaluation of SMEDDS (self-microemulsifying drug delivery system) containing fenofibrate},
  url          = {http://dx.doi.org/10.1208/aapsj0903041},
  volume       = {9},
  year         = {2007},
}

Chicago
Patel, Ashok, and Pradeep R Vavia. 2007. “Preparation and in Vivo Evaluation of SMEDDS (self-microemulsifying Drug Delivery System) Containing Fenofibrate.” Aaps Journal 9 (3): E344–E352.
APA
Patel, A., & Vavia, P. R. (2007). Preparation and in vivo evaluation of SMEDDS (self-microemulsifying drug delivery system) containing fenofibrate. AAPS JOURNAL, 9(3), E344–E352.
Vancouver
1.
Patel A, Vavia PR. Preparation and in vivo evaluation of SMEDDS (self-microemulsifying drug delivery system) containing fenofibrate. AAPS JOURNAL. 2007;9(3):E344–E352.
MLA
Patel, Ashok, and Pradeep R Vavia. “Preparation and in Vivo Evaluation of SMEDDS (self-microemulsifying Drug Delivery System) Containing Fenofibrate.” AAPS JOURNAL 9.3 (2007): E344–E352. Print.