PMID: 9450162Feb 5, 1998Paper

Influence of food on the pharmacokinetics of a new multiple unit sustained release sodium valproate formulation

Arzneimittel-Forschung
A RetzowM Wangemann

Abstract

The influence of concomitant food intake on the pharmacokinetics of sodium valproate (CAS 1039-66-5) was studied in 16 healthy male volunteers. A single dose of a new sustained release formulation containing 300 mg sodium valproate (Orfiril long) was administered on two occasions either after a 12-h over-night fast or immediately after a standardised high energy high fat breakfast. A wash-out period of at least 1 week elapsed between the administrations. Valproate serum concentrations were measured by gas chromatography at intervals suitable for obtaining concentration-time curves for both regimens up to 72 h. The mean maximum serum concentration after fasting (17.0 micrograms/ml) was virtually the same as after a meal (16.8 micrograms/ml). Maximum concentrations were reached after 8 h for both nutritional states. The rate of elimination was not affected (terminal half-life approximately 15 h). The mean AUC0-infinity values were 468 micrograms/ml x h in fasting subjects and 458 micrograms/ml x h in postprandial subjects. The 90% confidence intervals for all pharmacokinetic target parameters were entirely confined in the bioequivalence range of 80 to 125%. The confidence intervals were even tighter, thus demonstrating homogeneit...Continue Reading

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