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Divalproex to divalproex extended release conversion.

Sandeep Dutta1, Ronald C Reed

  • 1Global Pharmaceutical Research and Development, Abbott Laboratories, Abbott Park, Illinois, USA.

Clinical Drug Investigation
|May 26, 2007
PubMed
Summary
This summary is machine-generated.

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To switch from conventional divalproex to extended-release (ER) divalproex, an 8-20% higher daily dose of divalproex ER is recommended. This adjustment ensures therapeutic equivalence and offers improved patient adherence and drug monitoring.

Area of Science:

  • Pharmacokinetics
  • Drug Formulation
  • Epilepsy Treatment

Background:

  • Divalproex extended release (ER) tablets exhibit lower bioavailability compared to conventional divalproex tablets.
  • Understanding dose conversion is crucial for maintaining therapeutic efficacy when switching formulations.

Purpose of the Study:

  • To justify dose increments for converting patients from conventional divalproex to a once-daily divalproex ER regimen.
  • To elucidate pharmacokinetic factors influencing unequal total daily dose conversions between divalproex formulations.

Main Methods:

  • Bioavailability studies comparing equal and higher (8-20%) total daily doses of divalproex ER versus conventional divalproex.
  • Studies conducted in healthy volunteers and epilepsy patients (total n=168).

Related Experiment Videos

  • Multiple doses administered over 6-14 days for each regimen.

    • Main Results:

    • Divalproex ER showed approximately 89% bioavailability relative to conventional divalproex at equal total daily doses.
    • An 8-20% higher divalproex ER dose achieved equivalent bioavailability (AUC ratio ~1.0).
    • Divalproex ER resulted in less fluctuation in valproic acid concentrations, with higher minimum and lower maximum concentrations compared to conventional divalproex.

    Conclusions:

    • An 8-20% increase in the daily dose of divalproex ER is recommended for conversion from conventional divalproex.
    • Divalproex ER offers benefits including convenient once-daily dosing, reduced concentration fluctuations, and improved patient adherence.
    • The consistent trough concentrations and simplified dosing facilitate easier therapeutic drug monitoring.