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Absolute Bioavailability and Absorption Characteristics of Divalproex Sodium Extended-Release Tablets in Healthy Volunteers

From Abbott Laboratories, Abbott Park, Illinois.

Conventional delayed-release, enteric-coated divalproex sodium tablet has an absolute bioavailability of 100%. Divalproex sodium extended-release (ER) tablet is a novel formulation of valproic acid (VPA) designed to release the drug slowly at a constant zero-order rate. The purpose of this study was to evaluate the absolute bioavailability and absorption characteristics of divalproex ER. Healthy adult volunteers (n = 16) received divalproex ER and intravenous VPA in crossover fashion. Absolute bioavailability was calculated as the divalproex ER/intravenous VPA ratio of area under the curve extrapolated to infinity. The duration and rate of absorption of VPA from divalproex ER tablets were determined by deconvolution analysis. The geometric mean absolute bioavailability of divalproex ER was 0.896. The mean (coefficient of variation) duration of drug absorption from divalproex ER was 21.8 (17%) hours, and the zero-order absorption rate was 21.6 (24%) mg/h for a 500-mg tablet. Divalproex ER has a lower absolute bioavailability than conventional divalproex tablets but exhibits good extended-release characteristics without any dose dumping.

Key Words: Valproate • pharmacokinetics • modified release • sustained release

Address for reprints: Sandeep Dutta, PhD, Department R4PK, Building AP13A, 100 Abbott Park Road, Abbott Park IL 60064-6104.

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