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Apixaban oral tablet and preparation method thereof

A technology of oral tablet and apixaban, which is applied in the field of pharmaceutical preparations, can solve the problems of increasing the risk of work protection for operators, slow dissolution rate, toxic and side effects, etc., and achieve good taste, low friability and good stability Effect

Active Publication Date: 2020-03-31
CHANGZHOU HANSOH PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] CN110123770A A pharmaceutical composition of apixaban and its preparation method. Surfactants are used in this patent, which can bring toxic and side effects to the human body and increase the risk of work protection for operators
In the embodiment, the dissolution rate of apixaban tablets is relatively slow, and the dissolution rate is less than 90% in 10 minutes

Method used

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  • Apixaban oral tablet and preparation method thereof
  • Apixaban oral tablet and preparation method thereof
  • Apixaban oral tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0052] Dissolution test method: according to "Chinese Pharmacopoeia" 2015 edition four dissolution and release test method (general rule 0931 second method)

[0053] Temperature: 37℃±0.5℃, paddle method

[0054] Dissolution medium: pH 6.8 phosphate buffered saline solution with 0.05% sodium lauryl sulfate

[0055] Medium volume: 900mL

[0056] Speed: 75 rpm

[0057] Sampling: After 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes and 45 minutes, take the solution respectively, measure the dissolution rate at the corresponding point, and replenish the corresponding dissolution medium at the same temperature in the operating container in time.

[0058] Detection method: HPLC method.

[0059]

[0060] From the experimental results, it can be seen that when the prescription contains pregelatinized starch, the dissolution rate of the prepared tablet is better.

experiment example 2

[0062]

[0063] From the above experimental results, it can be seen that the content of pregelatinized starch will affect the dissolution effect.

experiment example 3

[0065]

[0066]

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Abstract

The invention provides an apixaban oral tablet and a preparation method thereof. The tablet comprises apixaban, pregelatinized starch, a diluent, a disintegrating agent, a flavoring agent, a flow aidand a lubricant. The apixaban oral tablet is simple in preparation method, safe, non-toxic, good in stability, high in dissolution rate, capable of being quickly disintegrated after being taken, and good in taste.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to an oral tablet of apixaban and a preparation method thereof. Background technique [0002] The chemical name of Apixaban is 1-(4-methoxyphenyl)-7-oxo-6[4-(2-oxopiperidin-1-yl)phenyl]-4,5 ,6,7-tetrahydro-1H-pyrazol[3,4-c]pyridine-3-carboxamide, the molecular formula is C 25 h 25 N 5 O4, its structural formula is as follows: [0003] [0004] Apixaban is an anticoagulant product jointly developed by Bristol-Myers Squibb and Pfizer, which is clinically used for the prevention of venous thrombosis in adult patients undergoing elective hip or knee replacement surgery. Apixaban was approved for marketing in the European Union in March 2011, and was approved by the FDA for marketing in the United States in December 2012. In 2013, it obtained the import drug license issued by the State Food and Drug Administration of China and was launched in China. [0005]...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/36A61K31/4545A61P7/02
CPCA61K9/2059A61K31/4545A61P7/02
Inventor 钟春华陈刚胜陈玮琦李倩
Owner CHANGZHOU HANSOH PHARM CO LTD