Characterisation of fenofibrate dissolution delivered by a self-microemulsifying drug-delivery system

Journal of Pharmacy and Pharmacology

Volumn 62, Issue 12, 2010, Pages 1685-1696

  Wei, Jyh Ding ^a   Ho, Hsiu O ^b   Chen, Chien Ho ^c   Ke, Wen Tin ^b   Chen, Eric Tsu Hsin ^a   Sheu, Ming Thau ^b  

^a SHIN KONG WU HO SU MEMORIAL HOSPITAL   (Taiwan)

^b School of Pharmacy   (Taiwan)

^c TAIPEI MEDICAL UNIVERSITY   (Taiwan)

Author keywords

d alpha tocopheryl polyethylene glycol 1000 succinate (TPGS); Dissolution; Fenofibrate; Microemulsion; Self microemulsifying drug delivery system (SMEDDS)

Indexed keywords

DODECYL SULFATE SODIUM; FENOFIBRATE; MEDIUM CHAIN TRIACYLGLYCEROL; OIL; POLYSORBATE 20; POLYSORBATE 80; SURFACTANT; TOCOFERSOLAN; WATER;

AREA UNDER THE CURVE; ARTICLE; DISPERSION; DRUG ABSORPTION; DRUG CLEARANCE; DRUG DELIVERY SYSTEM; DRUG DISTRIBUTION; DRUG FORMULATION; DRUG RELEASE; DRUG SOLUBILITY; GASTROINTESTINAL TRACT; HUMAN; HUMAN EXPERIMENT; MAXIMUM PLASMA CONCENTRATION; MICROEMULSION; NORMAL HUMAN; SELF MICROEMULSIFYING DRUG DELIVERY SYSTEM;

BIOLOGICAL AVAILABILITY; DRUG DELIVERY SYSTEMS; EMULSIFYING AGENTS; EXCIPIENTS; FENOFIBRATE; HYPOLIPIDEMIC AGENTS; POLYETHYLENE GLYCOLS; POLYSORBATES; PROPYLENE GLYCOL; SODIUM DODECYL SULFATE; SOLUBILITY; TRIGLYCERIDES; VISCOSITY; VITAMIN E;

EID: 78149398526     PISSN: 00223573     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.2042-7158.2010.01182.x     Document Type: Article

References (20)

1. Munoz A et al. Micronised fenofibrate. Atherosclerosis 1994; 110(Suppl.): S45-S48.
2. Miller DB, Spence JD. Clinical pharmacokinetics of fibric acid derivatives (fibrates). Clin Pharmacokinet 1998; 34: 155-162.
3. Stamm A, Seth P. FFB pharmaceutical composition having high bioavailability and method for preparing it. 2003; US Patent no. US 6, 589, 552 B2.
4. Guichard JP et al. A new formulation of FFB: suprabioavailable tablets. Curr Med Res Opin 2000; 16: 134-138.
5. Najib J. FFB in the treatment of dyslipidemia: a review of the data as they relate to the new suprabioavailable tablet formulation. Clin Ther 2002; 24: 2022-2050.
6. Sonet B et al. Randomized crossover studies of the bioequivalence of two FFB formulations after administration of a single oral dose in healthy volunteers. Arzneimittelforschung 2002; 52: 200-204.
7. Lipinski CA et al. Experimental and computational approaches to estimate solubility and permeability in drug discovery and development settings. Adv Drug Deliv Rev 1997; 23: 3-25.
8. Ke WT et al. Physical characterizations of microemulsion systems using tocopheryl polyethylene glycol 1000 succinate (TPGS) as a surfactant for the oral delivery of protein drugs. J Control Release 2005; 102: 489-507.
9. Pouton CW. Formulation of self-emulsifying drug delivery systems. Adv Drug Deliv Rev 1997; 25: 47-58.
10. Holm R et al. Examination of oral absorption and lymphatic transport of halofantrine in a triple-cannulated canine model after administration in self-microemulsifying drug delivery systems (SMEDDS) containing structured triglycerides. Eur J Pharm Sci 2003; 20: 91-97.
11. Khoo SM et al. Formulation design and bioavailability assessment of lipidic self-emulsifying formulations of halofantrine. Int J Pharm 1998; 167: 155-164.
12. Kim JY, Ku YS. Enhanced absorption of indomethacin after oral or rectal administration of a self-emulsifying system containing indomethacin in rats. Int J Pharm 2000; 194: 81-89.
13. Kang BK et al. Development of self-microemulsifying drug delivery systems (SMEDDS) for oral bioavailability enhancement of simvastatin in beagle dogs. Int J Pharm 2004; 274: 65-73.
14. Cooney GF et al. Comparative bioavailability of Neoral and Sandimmune in cardiac transplant recipients over 1 year. Transplant 1998; 30: 1892-1894.
15. Porter CJH, Charman WN. In vitro assessment of oral lipid based formulations. Adv Drug Deliv Rev 2001; 50: S127-S147.
16. Friman S, Backman L. A new microemulsion formulation of cyclosporine: pharmacokinetic and clinical features. Clin Pharmacokinet 1996; 30: 181-193.
17. Patel AR, Vavia PR. Preparation and in vivo evaluation of SMEDDS (self-emulsifying drug delivery system) containing fenofibrate. AAPS J 2007; 9: E344-E352.
18. Subramanian N et al. Formulation design of self-microemulsifying drug delivery systems for improved oral bioavailability of Celecoxib. Biol Pharm Bull 2004; 27: 1993-1999.
19. Park KM, Kim CK. Preparation and evaluation of flurbiprofen-loaded microemulsion for parenteral delivery. Int J Pharm 1999; 181: 173-179.
20. Dissolution Testing of Immediate Release Solid Oral Dosage Forms. Washington, DC: Guidance for Industry; U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), U.S. Government Printing Office, 1997.