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Afatinib dimaleate tablet and preparation method thereof

A technology of afatinib maleate and tinib tablets, which is applied in the field of afatinib maleate tablets and its preparation, can solve the problems of high substance content and low production efficiency, and improve the uniformity of mixing , simplified production process, and good product stability

Active Publication Date: 2020-02-25
SICHUAN KELUN PHARMA RES INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The object of the present invention is to provide Afatinib maleate tablet and preparation method thereof, to solve the problems of high content of related substances and low production efficiency in the existing Afatinib maleate tablet

Method used

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  • Afatinib dimaleate tablet and preparation method thereof
  • Afatinib dimaleate tablet and preparation method thereof
  • Afatinib dimaleate tablet and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0055] The afatinib maleate tablet in the present embodiment is made up of tablet core and the film coating that is wrapped in outside the tablet core, and tablet core is made of the raw material of following quality (making 1000): maleic acid afatinib Tini (calculated as afatinib dimaleate) 44.34g, lactose (F100) 185.79g, microcrystalline cellulose (PH101) 27.72g, crospovidone 5.40g, silicon dioxide 1.35g, hard Magnesium fatty acid 5.40g; Film coating adopts the raw material of following quality (making 1000 tablets): film coating premix (Opadry) 10.80g, purified water 79.20g.

[0056] The preparation method of Afatinib maleate tablet, comprises the following steps:

[0057] Step (1) ingredients: afatinib maleate is granulated with a 40-mesh sieve, and set aside. Dry each auxiliary material at a temperature of 80±5°C, the moisture content of each auxiliary material is: lactose≤1.0%, microcrystalline cellulose≤2.0%, crospovidone≤4.0%, silicon dioxide≤4.0%, and set aside.

[...

Embodiment 2

[0063] The afatinib maleate tablet in the present embodiment is made up of tablet core and the film coating that is wrapped in outside the tablet core, and tablet core is made of the raw material of following quality (making 1000): maleic acid afatinib Tini (calculated as afatinib dimaleate) 44.34g, lactose (F100) 185.79g, microcrystalline cellulose (PH101) 33.72g, crospovidone 5.40g, silicon dioxide 1.35g, hard Magnesium fatty acid 5.40g; Film coating adopts the raw material of following quality (making 1000 tablets): film coating premix (Opadry) 11.04g, purified water 80.95g. The preparation method is the same as in Example 1.

Embodiment 3

[0065] The afatinib maleate tablet in the present embodiment is made up of tablet core and the film coating that is wrapped in outside the tablet core, and tablet core is made of the raw material of following quality (making 1000): maleic acid afatinib Tini (calculated as afatinib dimaleate) 44.34g, lactose (F100) 185.79g, microcrystalline cellulose (PH101) 27.72g, crospovidone 8.25g, silicon dioxide 1.35g, hard Magnesium fatty acid 5.40g; Film coating adopts the raw material of following quality (making 1000 tablets): film coating premix (Opadry) 10.91g, purified water 80.03g. The preparation method is the same as in Example 1.

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Abstract

The invention relates to an afatinib dimaleate tablet and a preparation method thereof, which belong to the field of pharmaceutical preparations. The invention aims to solve the problems of high content of related substances and low production efficiency in the existing afatinib dimaleate tablet. According to the technical scheme, the afatinib dimaleate tablet is prepared from the following raw and auxiliary materials in parts by mass: 40 to 60 parts of afatinib dimaleate, 180 to 250 parts of lactose, 25 to 38 parts of microcrystalline cellulose, 4 to 9 parts of polyvinylpolypyrrolidone, 0.5 to 3.5 parts of silicon dioxide and 3 to 8 parts of magnesium stearate. The afatinib dimaleate tablet provided by the invention has the advantages of simple preparation process, good dissolution uniformity, and good stability.

Description

technical field [0001] The invention relates to afatinib maleate tablet and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Lung cancer is one of the most common malignant tumors in my country. There are about 600,000 new lung cancer patients every year, ranking first in the cause of cancer death. In the past, chemotherapy was the main treatment method for patients with advanced lung cancer. However, with the progress of lung cancer treatment-related research, it has been found that about 50% of non-small cell lung cancer patients in China have positive mutations in the EGFR gene. Drugs are the most ideal, and their curative effect is better than that of chemotherapy. [0003] Afatinib Dimaleate, chemical name: 2(E)-N-[4-[(3-chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro -3-furyl]oxyl]6-quinazolinyl]-4-(dimethylamino)-2-butenamide dimaleate, is an aniline quinazoline compound, manufactured by Boehringer ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K47/38A61K31/517A61P35/00
CPCA61K9/2095A61K9/2054A61K9/2866A61K31/517A61P35/00
Inventor 刘文友蒲婷婷周丹徐飞李雪胡祥琳蒲玉梅沈利赵栋王利春王晶翼
Owner SICHUAN KELUN PHARMA RES INST CO LTD
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