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Influence of food intake on the pharmacokinetics of a sustained release formulation of sodium valproate
Author(s) -
RoyerMorrot MarieJose,
Zhiri Azzedine,
Jacob Francine,
Necciari Jose,
Lascombes Francoise,
Royer Rene Jean
Publication year - 1993
Publication title -
biopharmaceutics and drug disposition
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.419
H-Index - 58
eISSN - 1099-081X
pISSN - 0142-2782
DOI - 10.1002/bdd.2510140607
Subject(s) - pharmacokinetics , valproic acid , chemistry , sodium , pharmacology , food intake , plasma concentration , zoology , endocrinology , medicine , epilepsy , biology , organic chemistry , psychiatry
The effect of food intake on the pharmacokinetics of DEPAKINE® CHRONO 500 mg (Sanofi, France), a sustained release formulation containing 333 mg sodium valproate and 145 mg valproic acid, was studied in 12 young healthy female volunteers. Relative to fasting conditions (F), when the tablet was given at the midpoint of the breakfast (NF), the maximum concentration (F: 34.6 ± 8.9 μg ml −1 and NF: 40.9 ± 7.3 μg ml −1 ; p = 0.014) and the mean cumulative amount absorbed up to time 6 h (F: 76.3 ± 11.8% and NF: 90 ± 10.4%; p = 0.0099) were significantly increased. Nevertheless, the extent of absorption (F: 46.7 ± 9.9 mg l −1 ; NF: 48 ± 7.7 mg l −1 ) was not significantly affected. There was no change in the area under the curve (1129 μg.h ml −1 ), in the mean residence time (28 h), or in the elimination half‐life (16 h). On the basis of this study, the question as to whether DEPAKINE® CHRONO should be administered to subjects in the fasting or non‐fasting state would not appear to be a major consideration when deciding on the regimen.