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Extended release formulation of divalproex sodium

A technology of sodium divalproate and valproic acid, applied in the directions of non-active ingredients medical preparations, pill delivery, anhydride/acid/halide active ingredients, etc.

Inactive Publication Date: 2005-09-21
RANBAXY LAB LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, stickiness problems still exist when conventional grades of silica are used and can only be overcome by using a specific grade of silica (Syloid® 244) which has a larger average particle size of about 1 -10 micron range

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 7

[0055] Adopt following method, press the composition preparation tablet of embodiment 6:

[0056] The divalproex sodium, hypromellose and lactose were mixed in a rapid mixing granulator. Granules were prepared by adding granulation fluid (0.5 mg / ml hydroxypropylmethylcellulose dispersion in purified water) to the drug / polymer / lactose mixture. The granules obtained are dried in a fluid bed drier and sieved through a suitable sieve. The dried granules are mixed with talc and magnesium stearate, compressed into tablets of suitable size, and coated with an aqueous dispersion of PEG 400 and Opadry.

[0057] Then, the sustained-release tablets prepared according to Examples 1-6 were evaluated for hardness and friability. Use Scheulinger Tablet hardness tester (to embodiment 3-6) and Vankel hardness tester (to embodiment 1 and 2), press the hardness of the slow-release tablet of the composition measurement divalproex sodium of embodiment 1-6, The results are listed in Table 1.

...

Embodiment 4

[0065] The divalproex sodium sustained-release tablet of embodiment 4 (equivalent to 500mg valproic acid)

[0066] time (hours)

Cumulative percentage (%) release of valproic acid

Example 4

Depakote® ER Tablets (500mg)

1

9

8

3

22

19

5

33

29

9

49

44

12

59

60

18

79

102

[0067] Table 3 presents the comparative dissolution data of the commercially available Depakote(R) ER (2 x 500 mg) and the divalproex sodium extended-release tablets of Examples 5-6. Tests were performed using a USP Type II dissolution apparatus with paddles at a speed of 100 rpm. Tablets were tested in 900 ml of phosphate buffer (pH 6.8) with 1% sodium lauryl sulfate. Tablets were held in sinker baskets #10 with paddles at a height of 4.5 cm from the bottom.

[0068] table 3

[0069] ...

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PUM

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Abstract

The present invention relates to an extended release pharmaceutical composition comprising valproic acid, a pharmaceutically acceptable salt, ester, or amide thereof or divalproex sodium.

Description

field of invention [0001] The present invention relates to sustained-release pharmaceutical composition comprising valproic acid, its pharmaceutically acceptable salt, ester or amide or divalproex sodium. Background of the invention [0002] Valproic acid, valproamide, and pharmaceutically acceptable salts and esters are effective in the treatment of mania, migraine, and epilepsy. After ingestion, they dissociate into valproate ions in the gastrointestinal tract, which upon absorption produce the desired therapeutic effect. [0003] Valproic acid and its derivatives are liquid, or rapidly liquefy, becoming viscous. And by nature, most are extremely hygroscopic. These physicochemical properties make it a serious problem in the manufacture of pharmaceutical compositions. [0004] Another disadvantage that valproic acid and its derivatives have is the rather short elimination half-life. For example, valproic acid has been reported to have a short half-life between 6-17 hour...

Claims

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Application Information

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IPC IPC(8): A61J3/06A61K9/20A61K9/22A61K9/48A61K31/16A61K31/19A61K31/22A61K47/02A61K47/30A61K47/32A61K47/34A61K47/36A61K47/38A61K47/46A61P25/00A61P25/06A61P25/08
CPCA61K9/2054A61K31/19A61K9/2095A61P25/00A61P25/06A61P25/08
Inventor P·库马G·K·简恩A·兰帕尔
Owner RANBAXY LAB LTD
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