Controlled release formulation of divalproex sodium

A technology of divalproex sodium and valproic acid, which is applied in the fields of medical preparations of non-active ingredients, pill delivery, active ingredients of anhydrides/acids/halides, etc., and can solve problems such as inappropriate dosing regimens
CN1335769AInactive Publication Date: 2002-02-13ABBOTT LAB INC
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
ABBOTT LAB INC
Publication Date
2002-02-13
Estimated Expiration
Not applicable · inactive patent

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Abstract

A controlled release tablet formulation which permits once daily dosing in the treatment of epilepsy comprises from about 50 weight percent to about 55 weight percent of an active ingredient selected from the group consisting of valproic acid, a pharmaceutically acceptable salt or ester of valproic acid, divalproex sodium, and valpromide; from about 20 weight percent to about 40 weight percent hydroxypropyl methylcellulose; from about 5 weight percent to about 15 weight percent lactose, from about 4 weight percent to about 6 weight percent microcrystalline cellulose, and from about 1 weight percent to about 5 weight percent silicon dioxide having an average particle size ranging between about 1 micron and about 10 microns; all weight percentages based upon the total weight of the tablet dosage form. Also disclosed are pre-tableting granular formulations, methods of making the granular formulations and tablets, and a method of treating epilepsy employing the controlled release tablet formulations of the invention.
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Description

technical field

[0001] The present invention relates to pharmaceutical preparations. More specifically, the present invention relates to formulations containing valproic acid, its pharmaceutically acceptable salts, esters or amides, or divalproex sodium in controlled release tablets. Background of the invention

[0002] 2-Propylpentanoic acid, commonly known as valproic acid (VPA), its amide valproamide (VPO), and certain salts and esters of this acid are effective in the treatment of seizures and as neuroleptics. US4988731 to Meade discloses oligomers of sodium valproate and valproic acid having a molar ratio of 1:1 and containing 4 units. US 5212326 to Meade discloses a stable non-hygroscopic solid form of valproic acid comprising sodium valproate and valproic acid oligomers in a molar ratio of 1:1 and containing 4-6 units. Divalproex sodium (sodium hydrogen divalproex) is one of the most widely used antiepileptic agents.

[0003] However, despit...

Claims

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