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Pradaxa composition

A technology for dabigatran etexilate mesylate and a composition is applied in the field of pharmaceutical compositions containing dabigatran etexilate mesylate and the field of preparation thereof, and can solve the problems of numerous production processes, difficulty in industrialized production, and methanesulfonic acid. Problems such as complex production process of dabigatran etexilate capsules

Inactive Publication Date: 2015-05-27
肖广常
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It can be seen that the production process of Boehringer Ingelheim's dabigatran etexilate mesylate capsules is extremely complicated, with numerous production processes and high production costs
Therefore, it is difficult to achieve industrial production of this process in China.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024]

[0025] Preparation:

[0026] (1) Micronize dabigatran etexilate mesylate to make D 90 Below 20μm.

[0027] (2) Dissolve the prescribed amount of sodium lauryl sulfate and povidone K30 in the prescribed amount of purified water, and use it as an adhesive for later use.

[0028] (3) Mix the prescribed amount of dabigatran etexilate mesylate, lactose, and microcrystalline cellulose evenly, add a binder to make a soft material, granulate, dry, and granulate.

[0029] (4) Compressed tablets, each containing 50 mg of dabigatran etexilate mesylate (as dabigatran etexilate).

Embodiment 2

[0031] The granules prepared in Example 1 are packed into capsules, each containing dabigatran etexilate mesylate 50mg (as dabigatran etexilate).

Embodiment 3

[0033]

[0034] Preparation:

[0035] (1) Micronize dabigatran etexilate mesylate to make D 90 Below 20μm.

[0036] (2) Dissolve the prescribed amount of poloxamer and povidone K30 in purified water and use it as an adhesive for later use.

[0037] (3) Mix the prescription amount of dabigatran etexilate mesylate, lactose, and pregelatinized starch evenly, add binder to make soft material, granulate, dry, and granulate.

[0038] (4) Compressed tablets, each containing 50 mg of dabigatran etexilate mesylate (as dabigatran etexilate).

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PUM

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Abstract

The invention provides a drug combination, which is characterized by comprising one or more isolated solid form oral dosage units. Each dosage unit contains 10mg-500mg of a mixture of pradaxa and one or more pharmaceutically acceptable excipients, and the pradaxa's particle size distribution range D90 is lower than 200 micrometers. The composition can be used for preventing venous thrombosis after total hip / knee joint replacement, and reducing the risk of stroke and systemic embolism in non-valvular atrial fibrillation patients.

Description

Technical field: [0001] The invention belongs to the field of pharmaceutical preparations. More specifically, the present invention relates to a pharmaceutical composition containing dabigatran etexilate mesylate and a preparation method thereof. Background technique: [0002] The invention relates to a pharmaceutical composition of dabigatran etexilate mesylate. Dabigatran etexilate mesylate has the following structure: [0003] [0004] Dabigatran etexilate mesylate has the function of inhibiting thrombin and prolonging the thrombin time. Boehringer Ingelheim, Germany will develop the oral capsule of this compound, trade name (PRADAXA), and obtained it in the European Union in 2008. Approved by the FDA in 2010 and in Japan in 2011. Boehringer Ingelheim applied for the patent of this preparation in China in 2003, and the application number is 20091014980.6. Known from this patent, the dabigatran etexilate mesylate capsule filler of Boehringer Ingelheim, Germany is a ...

Claims

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Application Information

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IPC IPC(8): A61K31/4439A61K47/38A61K47/36A61P7/02
Inventor 孙英肖广常王建华
Owner 肖广常
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