Bioavailability of oral vitamin E formulations in adult volunteers and children with chronic cholestasis or cystic fibrosis.

Abstract

PURPOSE:

To test bioequivalence of oral vitamin E formulations, water-soluble tocofersolan (test) and water-miscible (reference), in healthy adult volunteers, and their bioavailability in children with chronic cholestasis or cystic fibrosis.

METHODS:

In a two-way open randomized single dose cross-over design, 1200 IU were administered in 12 healthy volunteers and 100 IU/kg in 12 children with chronic cholestasis or cystic fibrosis.

RESULTS:

In healthy volunteers, formulations were not bioequivalent with a higher exposure to tocofersolan. In cholestatic children tocofersolan bioavailability was significantly higher than reference formulation (maximum plasma concentration: P = 0.008 and AUC: P = 0.0026). Bioavailability was not statistically different in cystic fibrosis.

CONCLUSIONS:

Oral tocofersolan was more bioavailable than the reference formulation in children with chronic cholestasis and similarly bioavailable in cystic fibrosis. Tocofersolan may represent an alternative to painful intramuscular vitamin E injections in chronic cholestasis, or to other oral formulations in cystic fibrosis.

• Authors: E Jacquemin, B Hermeziu, Y Kibleur, I Friteau, D Mathieu, F Le Coz, D Moyse, M Gérardin, E Jacqz-Aigrain, A Munck
• Journal: Journal of clinical pharmacy and therapeutics (J Clin Pharm Ther) Vol. 34 Issue 5 Pg. 515-22 (Oct 2009) ISSN: 1365-2710 [Electronic] England
• PMID: 19744007 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Vitamin E

Topics

• Administration, Oral
• Adolescent
• Adult
• Biological Availability
• Chemistry, Pharmaceutical
• Child
• Child, Preschool
• Cholestasis (metabolism)
• Chronic Disease
• Cross-Over Studies
• Cystic Fibrosis (metabolism)
• Humans
• Infant
• Middle Aged
• Vitamin E (administration & dosage, adverse effects, pharmacokinetics)