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KMID : 0378019940370100105
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New Medical Journal
1994 Volume.37 No. 10 p.105 ~ p.112
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Pharmacolinetic & Clinical Study of Controlled Release Form (Deparkine Chrono) Sodium Valproate
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Abstract
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Valproic acid (VPA) is one of the popularly prescribing anti-epileptic drugs. Although the spectrum of the VPA is wide, rapid absorption and fluctuation of serum concentration causes frequent adverse effects and poor compliance. Recently, with the purpose of maintaining stable serum concentration and less side effects with once a day therapy of VPA, sustained release form of VPA was developed.
A single-dose, cross-over study of 10 healthy volunteers was performed to compare the pharmacokinetic characteristics of sustained-release form of VPA (DepC) with conventional enetric coated VPA (VPA-EC). Also, serum concentrations of five volunteers of both drugs in maintenance state were also evaluated. Finally, the adverse effects and clinical efficacy of DepC were compared with VPA-EC in chronic, medically resistant epileptic patients.
Though DepC had less efficient bioavailability than the conventional VPA-EC, it had the pharmacokinteic characteristics of sustained release form, hence Cmax was consistently lower and Tmax was larger than VPA-EC. Adverse effects and efficacy for seizure control were not significatly different between the formulations.
Because of the stable serum concentrations, it is recommendable that DepC may be safely used for epileptic patients. Further study of stationary state pharmacokinetic with DepC in chronic epileptics may riislose the usefulness of DepC in clinical practice.
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