Divalproex sodium tablets
OwnerChih-Ming Chen, Boyong Liinventors
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Abstract
A process for preparing divalproex sodium tablets is provided. The process comprises preparing a neutralized divalproex sodium solution by combining divalproex sodium, having a sodium valproate and a valproic acid moiety, with an aqueous solvent and a base, e.g., sodium hydroxide, the base being in sufficient amount to ensure neutralization of the valproic acid moiety of the divalproex sodium. The neutralized divalproex sodium solution is sprayed onto a pharmaceutically acceptable carrier, and processed to obtain divalproex sodium tablets.
Claims30
An oral solid dosage form comprising a therapeutically effective amount of neutralized divalproex sodium which provides a delayed release of valproate ion when the neutralized divalproex sodium dosage form is orally administered to human patients, said dosage form being bioavailable and providing a therapeutic effect which is bioequivalent to a delayed release divalproex sodium tablet, (Depakote®).
An oral solid dosage form comprising a therapeutically effective amount of neutralized divalproex sodium which provides a delayed release of valproate ion when the neutralized divalproex sodium dosage form is orally administered to human patients, said dosage form being bioavailable and providing a therapeutic effect, and said dosage form providing a mean time to maximum plasma concentration (TMAX) of valproic acid at from about 1.8 to about 13.15 hours after oral administration.
An oral solid dosage form comprising a therapeutically effective dose of neutralized divalproex sodium and a pharmaceutically acceptable carrier, said dosage form providing a mean time to maximum plasma concentration (TMAX) of valproic acid at from about 1.8 to about 13.15 hours after oral administration.
Dependencies are inferred from the claim text.