Different serum concentrations of steady-state valproic acid in two sustained-release formulations.

Abstract:

:Recently a new sustained-release formulation of valproic acid has been developed in Japan. The sustained-release mechanism of the new formulation was different from the conventional formulation. The aim of the present study was to compare the pharmacokinetic characteristics of valproic acid in two sustained-release formulations. Different sustained-release formulations of valproic acid (Depakene R and Selenica R) were administered in a randomized cross-over fashion in repeated doses in 24 psychiatric patients. After > or = 4 weeks administration of valproic acid once daily, blood samples were taken just before (0 h) and 8, 12, 24 h after the morning dose. Blood sampling was performed in the same manner in the same patients 4 weeks after switching from one to the other formulation of valproic acid. Serum concentrations of valproic acid at 0 h (50.7 +/- 19.4 vs 44.9 +/- 21.8 microg/mL, P < 0.05) and 24 h (52.3 +/- 19.54 vs 6.2 +/- 22.2 microg/mL, P < 0.05) were significantly higher during Selenica R than during Depakene R treatment, whereas the serum concentration of valproic acid at 8 h (49.7 +/- 19.2 vs 62.4 +/- 25.6 microg/mL, P < 0.01) was significantly lower during Selenica R treatment than during Depakene R treatment. Serum concentrations of valproic acid at 12 h were not different. The present study demonstrated that steady-state serum concentrations were different because of the different dissolution profiles. When a prescription for valproic acid is switched from one drug to the other, prescribers should be aware that the therapeutic drug monitoring data are not consistent.

authors

Yasui-Furukori N,Saito M,Nakagami T,Niioka T,Sato Y,Fujii A,Kaneko S

doi

10.1111/j.1440-1819.2007.01656.x

subject

Has Abstract

pub_date

2007-06-01 00:00:00

pages

308-12

issue

3

eissn

1323-1316

issn

1440-1819

pii

PCN1656

journal_volume

61

pub_type

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