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Apixaban tablet and preparation method thereof

A technology of apixaban tablets and apixaban, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., can solve problems such as complex processes and difficult promotion and implementation, and achieve Avoid granulation process, short production cycle and simple production process

Pending Publication Date: 2022-06-28
JIANGSU SINOBIOPHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The above-mentioned prior art is to improve the dissolution rate of apixaban, and the process is relatively complicated, so it is difficult to popularize and implement

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Apixaban: 5mg;

[0032] Lactose: 52mg;

[0033] Microcrystalline cellulose: 37mg;

[0034] Croscarmellose sodium: 4mg;

[0035] Sodium Lauryl Sulfate: 1mg;

[0036] Magnesium stearate: 1mg;

[0037] Film coating: 3.5 mg.

Embodiment 2

[0039] Apixaban: 5mg;

[0040] Lactose: 60mg;

[0041] Microcrystalline cellulose: 29mg;

[0042] Croscarmellose sodium: 4mg;

[0043] Sodium Lauryl Sulfate: 1mg;

[0044] Magnesium stearate: 1mg;

[0045] Film coating: 3.5 mg.

Embodiment 3

[0047] Apixaban: 5mg;

[0048] Lactose: 49mg;

[0049] Microcrystalline cellulose: 40mg;

[0050] Croscarmellose sodium: 4mg;

[0051] Sodium Lauryl Sulfate: 1mg;

[0052] Magnesium stearate: 1mg;

[0053] Film coating: 3.5 mg.

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PUM

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Abstract

The invention provides an apixaban tablet and a direct tabletting method of apixaban powder, which comprises the following steps: taking apixaban, mixing with microcrystalline cellulose, sieving, and uniformly mixing; mixing with part of lactose; uniformly mixing the mixture with the residual lactose, the cross-linked sodium carboxymethyl cellulose and the lauryl sodium sulfate; and finally adding magnesium stearate, mixing, sampling, detecting, tabletting and coating. The preparation method is simple in production process, good in controllability and low in cost, and the obtained product is rapid in dissolution and good in content uniformity.

Description

technical field [0001] The invention relates to an apixaban tablet and a preparation method thereof, belonging to the technical field of medicine preparation. Background technique [0002] Apixaban is a selective active site inhibitor of human factor Xa (FXa). It was jointly developed by Bristol-Myers Squibb and Pfizer. It was approved by the European Medicines Agency in May 2011 for use in adult patients. Prevention of venous thrombosis (VTE) after hip or knee replacement surgery. [0003] Apixaban was launched in Canada, Japan, and the United States in December 2012 in 2.5mg and 5mg; it was launched in China in 2013 under the trade name: The dosage form is tablet, and the market size is 2.5mg. The EMA review report discloses that the production process of Aleto is a dry granulation process. The main steps are: mixing, dry granulation, mixing, tableting, coating and packaging. [0004] Patent CN102770126A discloses an apixaban preparation and a preparation method thereo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K31/4545A61K47/38A61K47/26A61P7/02A61P9/14
CPCA61K31/4545A61K9/2054A61K9/2018A61K9/2806A61P7/02A61P9/14
Inventor 黄乐群边崇安刘勇
Owner JIANGSU SINOBIOPHARMA
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