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The population pharmacokinetic parameters of valproic acid in pediatric patients taking tablets (Depakene® R) which were designed to be long acting were estimated using the standard two-stage method. On this study, the patients comprised seven pediatric outpatients of our hospital, aged 8 to 12 years old, all of whom were in the steady-state level. Blood samples were collected just before administration and six times thereafter until 30 h. The pharmacokinetic parameters were calculated by utilizing a one-compartment model with first-order absorption after a lag time by using the Phaconet-Depakene® program.Although the estimated population pharmacokinetic parameters, apparent elimination rate constant (Ke, h-1), apparent volume of distribution (Vd, 1/kg) and apparent absorption lag time (Lag, h) of pediatric patients did not differ from those of adult healthy volunteers reported previously, apparent absorption rate constant (Ka, h-1) was significantly smaller than that of adults. Prediction of the maximum and minimum concentration with the Bayesian method using these estimated parameters and one-point serum concentration data showed that the prediction error was less than 10%. At the steady state, the concentration of serum valproic acid decreased until 2.9h after administration. It is noteworthy important that the esrum concentration level about 3 hours after administration of Depakene® R did not indicate the maximum concentration but rather the minimum concentration.In conclusion, the estimated population pharmacokinetic parameters of valproic acid in pediatric patients taking Depakene® R were determined for the Bayesian analysis by Phaconet-Depakene®.

Clinical Pharmacokinetics of Valproic Acid in Pediatric Patients Taking Long Active Tablets. Estimation of Population Pharmacokinetic Parameters.