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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

Inactive Publication Date: 2002-02-13
ABBOTT LAB INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Frequent dosing is required to maintain adequately stable plasma concentrations, often making patients less comfortable with prescribed dosing regimens
In addition, wide fluctuations in plasma concentrations of this drug can make the amount administered in a conservative dosing regimen less than the therapeutic amount of the drug, or in an aggressive treatment too high for a particular patient

Method used

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  • Controlled release formulation of divalproex sodium
  • Controlled release formulation of divalproex sodium
  • Controlled release formulation of divalproex sodium

Examples

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Embodiment Construction

[0022] The terms "sustained release", "delayed release" and "controlled release" as applied to pharmaceutical formulations in the specification and claims of this application are defined in "Remington's Pharmaceutical Sciences," 18 th Ed., p. 1677, Mack Pub. Co., Easton, PA (1990) on their meaning. Sustained-release drug systems include any drug delivery system that achieves sustained release of a drug over an extended period of time, and includes time-release and controlled-release systems. Such a sustained release system is considered a controlled release drug delivery system if it is effective in maintaining substantially constant drug levels in the blood and target tissues. However, if a drug delivery system fails to achieve substantially constant blood or tissue drug levels, but prolongs the duration of drug action beyond that achieved by conventional release, it is considered a delayed release system.

[0023] The formulations of the present invention provide controlled...

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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.

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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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/26A61K9/20A61K9/22A61K31/16A61K31/19A61K31/23A61K47/02A61K47/26A61K47/38A61P25/08
CPCA61K9/2054A61K31/19A61K9/2018A61K9/2009A61P25/08A61P25/28A61K9/20
Inventor Y·丘R·P·波斯卡H·S·切斯金J·D·博林格K·R·恩格
Owner ABBOTT LAB INC
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