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 Divalproex Sodium Uses 

Pharmacodynamics Divalproex sodium dissociates to the valproate ion in the gastrointestinal tract. The mechanisms by which valproate exerts its therapeutic effects have not been established. It has been suggested that its activity in epilepsy is related to increased brain concentrations of gamma-aminobutyric acid.


Pharmacokinetics

However, it is possible that differences among the various valproate products in Tmax and Cmax could be important upon initiation of treatment. For example, in single dose studies, the effect of feeding had a greater influence on the rate of absorption of the tablet (increase in Tmax from 4 to 8 hours) than on the absorption of the sprinkle capsules (increase in Tmax from 3.3 to 4.8 hours).


Divalproex sodium dissociates to the valproate ion in the gastrointestinal tract. The mechanisms by which valproate exerts its therapeutic effects have not been established. It has been suggested that its activity in epilepsy is related to increased brain concentrations of gamma-aminobutyric acid.


In five multiple-dose studies in healthy subjects (N= 82) and in subjects with epilepsy (N= 86), when administered under fasting and nonfasting conditions, given once daily produced an average bioavailability of 89% relative to an equal total daily dose of  given BID, TID, or QID. The median time to maximum plasma valproate concentrations (Cmax) after administration ranged from 4 to 17 hours. After multiple once-daily dosing of the peak-to-trough fluctuation in plasma valproate concentrations was 10-20% lower than that of regular.


A new oral polymeric controlled release formulation suitable for the once-a-day administration of valproate compounds, such as divalproex sodium, has been discovered. This formulation exhibits significant advantages over the sustained release valproate formulations of the prior art. This formulation minimizes the variation between peak and trough plasma levels of valproate over a 24 hour dosing period. This formulation follows a zero-order release pattern thus producing essentially flat plasma levels of valproate, once steady-state levels have been achieved. This results in a significantly lower incidence of side effects for patients consuming such a formulation.




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