Bioavailability of oral vitamin E formulations in adult volunteers and children with chronic cholestasis or cystic fibrosis.
OBJECTIVE
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.
Jacquemin
E
E
Paediatric Hepatology and National Reference Centre for Biliary Atresia, Assistance Publique-Hôpitaux de Paris, Université Paris-Sud XI, CHU Bicêtre, Le Kremlin Bicêtre, France. emmanuel.jacquemin@bct.aphp.fr
Hermeziu
B
B
Kibleur
Y
Y
Friteau
I
I
Mathieu
D
D
Le Coz
F
F
Moyse
D
D
Gérardin
M
M
Jacqz-Aigrain
E
E
Munck
A
A
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D001682:Biological Availability; D002626:Chemistry, Pharmaceutical; D002648:Child; D002675:Child, Preschool; D002779:Cholestasis / Q000378:metabolism*; D002908:Chronic Disease; D018592:Cross-Over Studies; D003550:Cystic Fibrosis / Q000378:metabolism*; D006801:Humans; D007223:Infant; D008875:Middle Aged; D014810:Vitamin E / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*
D014810:Vitamin E