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Effects of the abrupt switch from solution to modified-release granule formulation of valproate

A Verrotti1, G Nanni, S Agostinelli

  • 1Department of Pediatrics, University of Chieti, Italy.

Acta Neurologica Scandinavica
|June 29, 2011
PubMed

Insights

The new valproate (VPA) modified-release (MR) granule formulation is effective and well-tolerated in children with epilepsy, offering improved palatability and ease of administration compared to liquid VPA. This epilepsy treatment option ensures continued use by patients.

Area of Science:

  • Pediatric Neurology
  • Pharmacology
  • Epilepsy Treatment

Background:

  • A novel modified-release (MR) valproate (VPA) granule formulation was developed for pediatric epilepsy.
  • This formulation uses tasteless microspheres, easily administered with food.
  • No prior data existed on its effectiveness in children.

Purpose of the Study:

  • To assess the impact of switching from VPA solution to MR granules in pediatric patients.
  • To evaluate efficacy, tolerability, and administration convenience.

Main Methods:

  • Children on chronic VPA therapy were switched from solution to MR granules at equivalent doses.
  • Evaluations included VPA blood levels, clinical and EEG efficacy, adverse reactions, palatability, and compliance.
  • Assessments were conducted before the switch (T0) and after 4 weeks (T1).

Main Results:

  • 108 of 112 children completed the study.
  • No significant changes in VPA blood levels, efficacy, tolerability, or compliance were observed post-switch.
  • MR granules were significantly preferred for palatability and ease of administration (P < 0.05).
  • All patients continued MR granule use at 6-month follow-up.

Conclusions:

  • The modified-release VPA granule formulation is a viable alternative to liquid VPA for pediatric epilepsy.
  • Its convenience in administration and palatability enhance treatment adherence.
  • This formulation offers a practical option for managing pediatric epilepsy.
Abstract

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