Valproat-Formulierungen mit gesteuerter Freigabe

An oral controlled release composition, including a valproate compound, suitable for once-a-day administration characterized in that when said composition is ingested orally, said composition produces a valproate Cmax that is statistically significantly lower than the valproate Cmax produced by a de...

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Hauptverfasser: BOLLINGER, DANIEL J, SOMMERVILLE, KENNETH W, CHESKIN, HOWARD S, QIU, YIHONG, POSKA, RICHARD P, ENGH, KEVIN R, DUTTA, SANDEEP
Format: Patent
Sprache:ger
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Zusammenfassung:An oral controlled release composition, including a valproate compound, suitable for once-a-day administration characterized in that when said composition is ingested orally, said composition produces a valproate Cmax that is statistically significantly lower than the valproate Cmax produced by a delayed release divalproex sodium tablet, when each is determined at steady state in a fasting population. This composition minimizes the variation between peak and trough plasma levels of valproate over a 24 hour dosing period. This composition 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 composition.