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.
Claims56
A pharmaceutical formulation comprising a therapeutically effective dose of neutralized divalproex sodium and a pharmaceutically acceptable carrier.
A process for preparing an orally administrable divalproex sodium formulation, which comprises
- (a) preparing a neutralized divalproex sodium solution by combining divalproex sodium, having a sodium valproate moiety and a valproic acid moiety, with a base and an aqueous solvent, the base being added in sufficient amount to ensure neutralization of the valproic acid moiety of the divalproex sodium, and
- (b) spraying the neutralized divalproex sodium solution onto a pharmaceutically acceptable carrier.
A process for preparing a divalproex sodium tablet, which comprises
- a) preparing a neutralized divalproex sodium solution by combining divalproex sodium, having a sodium valproate moiety and a valproic acid moiety, with a base and an aqueous solvent, the base being added in sufficient amount to ensure neutralization of the valproic acid moiety of the divalproex sodium;
- b) spraying the neutralized divalproex sodium solution onto a pharmaceutically acceptable carrier;
- c) processing the pharmaceutically acceptable carrier sprayed with the neutralized divalproex sodium solution to obtain divalproex sodium granules;
- d) compressing said divalproex sodium granules together with effective amounts optional pharmaceutical excipients to obtain a divalproex sodium tablet containing a therapeutically effective amount of valproate ions;
- e) processing the divalproex sodium granules to obtain a tablet core;
- and
- f) applying an enteric coating to the divalproex sodium tablet core to produce a divalproex sodium delayed-release tablet.
A process for preparing an orally administrable divalproex sodium formulation, which comprises
- (a) preparing a neutralized divalproex sodium solution by combining divalproex sodium, having a sodium valproate moiety and a valproic acid moiety, with a base and an aqueous solvent, the base being added in sufficient amount to ensure neutralization of the valproic acid moiety of the divalproex sodium, and
- (b) spraying the neutralized divalproex sodium solution onto a plurality of inert beads, and the inert beads to obtain neutralized divalproex sodium coated beads.
- (c) compressing an effective amount of said neutralized divalproex sodium coated beads to form a tablet;
- and
- (d) coating said tablet with at least one coating layer comprising an enteric polymer to form an enteric coated tablet.
Dependencies are inferred from the claim text.