Meal-dependent absorption of enteric-coated sodium valproate.

The effect of meals on valproic acid (VPA) absorption from an enteric coated (EC) formulation was investigated. In study I, six adult normal volunteers received a single 500 mg dose of sodium valproate in randomized treatments: fasting (A), with a meal (B) or 3 hours after a meal (C). There were significant differences between treatments in the latency period (Lp) defined as the time during which measured concentrations of VPA were less than 1 microgram/ml. Lp values for treatments A, B and C were: 1.67 +/- 1.25 hr, 6.75 +/- 3.98 hr and 7.63 +/- 3.15 hr respectively. In study II, six subjects (five from study I) received in a randomized fashion a 400 mg intravenous bolus dose of VPA and a 500 mg EC VPA tablet, 3 hours after a meal. The mean Lp value was 8.1 +/- 1.6 hr and the mean bioavailability was 100%. Clearance, volume of distribution and half-life values obtained after intravenous dosing were comparable to literature values. These results indicate that food intake delays but does not decrease the extent of absorption of VPA from an enteric coated formulation.

RCT Entities:   Population Interventions Outcomes