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Bioavailability of oral vitamin E formulations in adult volunteers and children with chronic cholestasis or cystic fibrosis
Author(s) -
Jacquemin E.,
Hermeziu B.,
Kibleur Y.,
Friteau I.,
Mathieu D.,
Le Coz F.,
Moyse D.,
Gérardin M.,
JacqzAigrain E.,
Munck A.
Publication year - 2009
Publication title -
journal of clinical pharmacy and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.622
H-Index - 73
eISSN - 1365-2710
pISSN - 0269-4727
DOI - 10.1111/j.1365-2710.2009.01027.x
Subject(s) - bioavailability , bioequivalence , cystic fibrosis , cholestasis , medicine , gastroenterology , vitamin , fibrosis , pharmacology
Summary 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.