Pharmacokinetic evaluation of novel sustained‐release dosage forms of valproic acid in humans

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Abstract
1. Five new sustained‐release dosage forms of valproic acid (VPA) were developed.2. The new sustained‐release formulations were administered to six healthy subjects for comparison with a standard tablet and an i.v. preparation of the drug.3. Three of the formulations exhibited a more prolonged and uniform absorption rate and yielded more sustained serum levels after ingestion. These three formulations maintained serum therapeutic levels of VPA for 24 h after a single oral administration of 1 g, and were bioequivalent to a marketed standard tablet of VPA.4. The absorption profile of the various oral formulations was analysed pharmacokinetically, using the Loo‐Riegelman procedure.