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Hydrobromic acid vortioxetine gastric-soluble tablet and preparation method thereof

A technology of vortioxetine hydrobromide and gastric dissolution, which is applied in the field of medicine and achieves good application prospects and market prospects

Inactive Publication Date: 2015-05-27
郑州大明药物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The company has developed Vortioxetine Hydrobromide Gastric Dissolved Tablets, and determined its specification as 6.355 mg (calculated as Vortioxetine Hydrobromide), which has not yet been marketed in China

Method used

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  • Hydrobromic acid vortioxetine gastric-soluble tablet and preparation method thereof
  • Hydrobromic acid vortioxetine gastric-soluble tablet and preparation method thereof
  • Hydrobromic acid vortioxetine gastric-soluble tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] 1. Each component and its weight percentage are as follows:

[0026]

[0027] 2. Preparation method :

[0028] Take by weighing 12.7 g vortioxetine hydrobromide, 234.8 g mannitol, 12.0 g hydroxypropyl cellulose, 24.0 g microcrystalline cellulose and 9.0 g sodium starch glycolate respectively, after mixing and stirring evenly, add 100 g water wherein to continue Mix and stir evenly to obtain wet granules, pass through a 10-mesh sieve, dry in an oven at 65 °C for 1-2 hours, and pass through a 10-mesh sieve to obtain granules;

[0029] The granules obtained and the 7.5g magnesium stearate taken by weighing are added in the V-shaped mixer, and after mixing for 20-30 min, the mixture is obtained;

[0030] Add the mixture into the hopper of the tablet press, adjust the tablet weight to 0.15 g / tablet, and then perform tablet compression to obtain plain tablets;

[0031] Add the plain tablet into the coating pan, measure 61.1 g of the coating liquid, and spray coating ...

Embodiment 2

[0034] 1. Components and their weight percentages are shown in the following table:

[0035]

[0036] 2. Preparation method:

[0037] Weigh 12.7 g vortioxetine hydrobromide, 257.3 g mannitol, 4.5 g hydroxypropyl methylcellulose, 12.0 g crospovidone and 9.0 g croscarmellose sodium, mix and stir evenly Finally, add 27.8 g of water to it and continue mixing and stirring to obtain wet granules, pass through a 10-mesh sieve, dry in an oven at 65 °C for 1-2 h, and pass through a 10-mesh sieve to obtain granules;

[0038] The obtained granules and 4.5 g of zinc stearate weighed are added to a V-type mixer, and after mixing for 20 to 30 min, the mixture is obtained;

[0039] Add the mixture into the hopper of the tablet press, adjust the tablet weight to 0.15 g / tablet, and then perform tablet compression to obtain plain tablets;

[0040] Add the plain tablet into the coating pan, measure 61.1 g of the coating liquid, and spray coating at a speed of 3 g / kg per minute, the weig...

Embodiment 3

[0043] 1. Components and their weight percentages are shown in the following table:

[0044]

[0045] 2. Preparation method:

[0046] Weigh 12.7 g vortioxetine hydrobromide, 239.3 g starch, 15.0 g methylcellulose, 18.0 g microcrystalline cellulose and 12.0 g crospovidone, mix and stir evenly, add 100.0 g water to it Continue to mix and stir evenly to obtain wet granules, pass through a 10-mesh sieve, dry in an oven at 65 °C for 1-2 h, and pass through a 10-mesh sieve to obtain granules;

[0047] The obtained granules and 3.0 g of calcium stearate weighed are added to a V-shaped mixer, and after mixing for 20 to 30 min, the mixture is obtained;

[0048] Add the mixture into the hopper of the tablet press, adjust the tablet weight to 0.15 g / tablet, and then perform tablet compression to obtain plain tablets;

[0049] Add the plain tablet into the coating pan, measure 61.1 g of the coating liquid, and spray coating at a speed of 3 g / kg per minute, the weight of the prepa...

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Abstract

The invention relates to the technical field of medicines and in particular relates to a hydrobromic acid vortioxetine gastric-soluble tablet and a preparation method thereof. The hydrobromic acid vortioxetine gastric-soluble tablet comprises the following components in percentage by weight: 4.24% of hydrobromic acid vortioxetine, 1.0-5.0% of a lubricating agent, 81-91% of a filling agent, 2-5% of a binding agent and 2-15% of a disintegrating agent. Dissolution rate of the hydrobromic acid vortioxetine gastric-soluble tablet is similar to the foreign original standard, so that the hydrobromic acid vortioxetine gastric-soluble tablet has good application prospect and market prospect.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a vortioxetine hydrobromide gastric-dissolved tablet and a preparation method thereof. Background technique [0002] Vortioxetine was jointly developed by Lundbeck and Takeda Pharmaceuticals in the United States, and was approved by the Food and Drug Administration (FDA) for marketing in the United States on September 30, 2013, under the trade name Brintellix , with specifications of 5, 10, 15 and 20 mg, respectively, for the treatment of major depressive disorder in adults. The company has developed Vortioxetine Hydrobromide Gastric Dissolved Tablets, and determined its specification as 6.355 mg (calculated as Vortioxetine Hydrobromide), which has not yet been marketed in China. Contents of the invention [0003] The object of the present invention is to overcome the deficiencies in the prior art and provide a kind of vortioxetine hydrobromide stomach-dissolving tablet and ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K31/495A61K47/38A61P25/24
Inventor 毛影刘志庆王翠霞张亚惠苏国娜王雯丽林恒彪
Owner 郑州大明药物科技有限公司
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