Bioavailability of divalproex extended-release formulation relative to the divalproex delayed-release formulation

Biopharmaceutics & Drug Disposition
Sandeep Dutta, Yiming Zhang

Abstract

Divalproex sodium extended-release tablet (divalproex-ER) is a novel formulation of the conventional divalproex sodium delayed-release tablet (divalproex). In five multiple-dose studies in healthy subjects (n=82) and epilepsy patients (n=86) the estimates of divalproex-ER/divalproex ratios for steady-state 24 h valproic acid area under the curve (AUC) central values, maximum concentration (C(max)) central values and minimum concentration (C(min)) means had ranges of 0.77-0.97, 0.71-0.87 and 0.78-1.03, respectively. These studies used different divalproex regimens (two, three or four times daily) and meal conditions (fasting, low, medium and high calorie meals). Divalproex-ER was administered once daily. A meta-analysis of divalproex-ER/divalproex relative bioavailability across five studies under different meal conditions and divalproex dosing frequencies was performed. This meta-estimate of relative bioavailability was used to provide dosing recommendations for conversion of patients from divalproex to divalproex-ER. The estimated AUC, C(max) and C(min) divalproex-ER/divalproex ratios (95% confidence interval) were 0.89 (0.85-0.94), 0.79 (0.74-0.84) and 0.96 (0.90-1.02), respectively. The food and divalproex regimen had no eff...Continue Reading

References

Mar 1, 1985·Clinical Pharmacokinetics·D W Chadwick
Feb 12, 2002·Statistics in Medicine·Hans C van HouwelingenTheo Stijnen
May 26, 2007·Clinical Drug Investigation·Sandeep Dutta, Ronald C Reed

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Citations

Mar 20, 2010·Expert Opinion on Drug Metabolism & Toxicology·Brigitte V Lovell, Michael J Marmura
Jul 20, 2007·Current Medical Research and Opinion·Glen T SchumockJoyce A Cramer
Jul 11, 2007·Journal of Child Neurology·Alberto VerrottiFrancesco Chiarelli
Jan 12, 2017·Practical Neurology·Anna M BankAaron L Berkowitz
Nov 30, 2018·Expert Opinion on Pharmacotherapy·Monika BanachStanisław J Czuczwar

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