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Extended release pharmaceutical compositions of divalproex sodium

A technology of divalproex sodium and slow-release drugs, applied in drug combinations, active ingredients of anhydrides/acids/halides, nervous system diseases, etc.

Inactive Publication Date: 2007-02-28
RANBAXY LAB LTD
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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 a specific grade of silica (Syloid(R) 244) with a smaller average particle size of about 1-10 microns

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] The divalproex sodium, lactose, Methocel K-15M CR and Methocel E-5 were mixed in a rapid mixing granulator. Granules were prepared by adding granulation fluid (purified water) to the drug / polymer / lactose 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 tablets of suitable size and coated with PEG 400 and an aqueous Opadry dispersion.

[0050] Element

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PUM

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Abstract

The present invention relates to a sustained release preparation comprising valproic acid and the pharmaceutical acceptable salt, ester or amide, or divalproex sodium, and a preparation method of the sustained release preparation.

Description

technical field [0001] The present invention relates to sustained-release preparations comprising valproic acid, and pharmaceutically acceptable salts, esters or amides thereof or divalproex sodium (divalproex sodium) and a preparation method thereof. Background of the invention [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 compositions. [0004] In addition, valproic acid and its derivatives have short elimination half-lives. Fo...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61P25/08A61K31/19A61P25/28A61P25/06
CPCA61K31/19A61K9/2018A61K9/2054A61P25/06A61P25/08A61P25/28
Inventor P·库马G·K·简恩A·朗帕尔
Owner RANBAXY LAB LTD
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