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Divalproex sodium sustained-release tablet and preparation process thereof

A technology of sodium divalproex, valproic acid, applied in the direction of anhydride/acid/halide active ingredients, drug combinations, amide active ingredients, etc., can solve problems such as viscosity

Inactive Publication Date: 2011-05-11
YANGTZE RIVER PHARMA GRP BEIJING HAIYAN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

, however, when using conventional grades of silica, stickiness problems still exist and can only be overcome by using specific grades of silica with a smaller average particle size of about 1-10 μm

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1、2、3、4

[0038] The divalproex sodium, Methocel K-100M and Methocel K-4M were mixed in a rapid mixing granulator. Granules were prepared by adding granulation fluid (50% ethanol) to the drug / polymer mixture. The resulting granules are dried in a fluid bed dryer and sieved through a suitable sieve. The dried granules are mixed with talc, colloidal silicon dioxide and magnesium stearate, compressed into suitable size tablets and coated with PEG400 and Opardry aqueous dispersion.

[0039] Table 1 Composition of divalproex sodium sustained-release tablets

[0040] Element

[0041] In vitro dissolution test

[0042] Adopt the dissolution rate first method device (Chinese Pharmacopoeia version two appendix XD first method in 2005), rotating speed 100rpm, release 1 hour in 500ml artificial gastric juice, contain 1% sodium lauryl sulfate phosphate buffer saline (pH6. 8) released in 23 hours, the divalproex sodium sustained-release tablets composed as shown in Examples 1, 2, 3 and...

Embodiment 5、6

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PUM

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Abstract

The invention provides a method for preparing a divalproex sodium-containing sustained-release tablet for treating epilepsy. The sustained-release tablet contains divalproex sodium, a sustained-release material, a binder and a lubricant. The preparation method comprises the following steps of: mixing the divalproex sodium and the sustained-release material to obtain a mixture, adding the binder for wet granulation, drying, granulating, adding into other uniformly mixed auxiliary materials, and tabletting to obtain the divalproex sodium-containing sustained-release tablet. The sustained-release tablet can be sustainedly released for 24 hours, and is good in appearance, stable in performance and convenient to take.

Description

technical field [0001] The invention provides a sustained-release preparation for treating epilepsy, the main component of which is divalproex sodium. Background technique [0002] Valproic acid, 2-valproic acid and their derivatives are widely used in the treatment of mania, migraine and epilepsy. These compounds dissociate into the valproate ion in the gastrointestinal tract. [0003] Several physical properties of valproic acid and its derivatives make formulation into dosage forms problematic. They are liquid or liquefy rapidly and are viscous. Also by nature, most valproic acid and its derivatives are extremely hygroscopic. These physicochemical properties of valproic acid and its derivatives present serious problems in the manufacture of pharmaceutical formulations. [0004] In addition, the elimination half-life of valproic acid and its derivatives is also short. For example, it has been reported that the half-life of valproic acid is 6-17 hours in adults and 4-17...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/20A61K31/16A61K9/22A61K9/16A61P25/08
Inventor 宋志涛石和鹏侯鹏张小华白沙沙张培龙
Owner YANGTZE RIVER PHARMA GRP BEIJING HAIYAN PHARMA
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