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Favipiravir tablets and preparation method thereof

A technology of pravir tablets and favipiravir, which is applied in the field of medicine, can solve the problems of decreased drug compliance, low fluidity, and lack of compression molding properties, and achieves simple preparation process, good drug compliance, and good dissolution Effect

Active Publication Date: 2017-05-17
CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Favipiravir itself does not have properties such as compression molding, large specific volume, strong cohesion, and low fluidity, which causes the prepared tablet to have a larger diameter and cause a decrease in drug compliance. In order to overcome this defect, the patent CN102348458A discloses A tablet containing (1) 6-fluoro-3-hydroxyl-2-pyrazinecarboxamide or a salt thereof, (2) low-substituted hydroxypropyl cellulose or croscarmellose sodium, and ( 3) binder, wherein the content of the 6-fluoro-3-hydroxyl-2-pyrazinecarboxamide or its salt is 50-95% of the tablet mass, and the prescription can be compressed with an 8.5mm punch, Smaller tablet diameter, increased drug compliance, and better dissolution, thus solving the above problems
[0004] However, the low-substituted hydroxypropyl cellulose used as a disintegrating agent and excipient in this prescription is more expensive. For example, LH-1 purchased from Xinyue Chemical is about 380 yuan per kilogram, and the dosage is relatively large. Based on the calculation of 25 mg, each tablet costs 9.5 yuan, and 9,500 yuan is required to prepare 1,000 tablets. The patient has a great financial burden. If croscarmellose sodium is used to replace low-substituted hydroxypropyl cellulose, a large amount of additional dosage is required. excipients, tablet size becomes very large

Method used

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  • Favipiravir tablets and preparation method thereof
  • Favipiravir tablets and preparation method thereof
  • Favipiravir tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] The selection of embodiment 1 favipiravir tablet excipient

[0037] Weigh a certain amount of Favipiravir and each auxiliary material listed in Table 1 according to the prescription ratio, sieve and mix 10 times, add water to make a soft material, granulate with a 32-mesh sieve, dry at 50°C, and granulate with a 32-mesh sieve , add the converted sodium stearyl fumarate, mix well, and compress into tablets.

[0038] Table 1 Favipiravir tablet test results

[0039]

[0040] Remarks: The slash " / " in the above table indicates that the indicator has not been measured.

[0041] From the test results in the above table, it can be known that using microcrystalline cellulose as an excipient and disintegrant, if tablets with acceptable quality (such as suitable hardness, low friability and dissolution qualification) are to be prepared, the tablet size to be prepared should be Very large; using silicified microcrystalline cellulose 50 and low-substituted hydroxypropyl cellul...

Embodiment 4-13

[0042] Embodiment 4-13 favipiravir tablet binder, excipient consumption and sheet shape selection

[0043] Weigh a certain amount of Favipiravir listed in Table 2 and Table 3 according to the prescription ratio and the dosage of each auxiliary material, sieve and mix 10 times, add water to make a soft material, granulate with a 32-mesh sieve, dry at 50 ° C, 32-mesh Sieve for granulation, add the converted sodium stearyl fumarate, mix well, and press into tablets.

Embodiment 14-18

[0054] Embodiment 14-18 and comparative example 2-3 favipiravir tablet raw material particle size selection

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Abstract

The invention relates to favipiravir tablets. The tablets comprise favipiravir, silicified microcrystalline cellulose and adhesive; the silicified microcrystalline cellulose is lower in price, proper in size and high in medicine compliance when being compared with low-substituted hydroxypropyl cellulose; the defective rate is lower and the dissolution rate is higher. The invention further relates to a preparation method of the tablets. The preparation method is simple in preparation process and suitable for industrialized large-scale production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a favipiravir tablet and a preparation method thereof. Background technique [0002] Favipiravird (favipiravird), the chemical name is 6-fluoro-3-hydroxypyrazine-2-carboxamide, the original research company is Toyama Chemical Industry Co., Ltd., and it was listed in Japan in July 2011. It is used for the treatment of new or Recurrent influenza virus infection (limited to use when other anti-influenza virus drugs are ineffective or the curative effect is not significant). [0003] Favipiravir itself does not have properties such as compression moldability, large specific volume, strong cohesion, and low fluidity, which results in a larger diameter of the prepared tablet and a decrease in drug compliance. In order to overcome this defect, the patent CN102348458A discloses A tablet containing (1) 6-fluoro-3-hydroxyl-2-pyrazinecarboxamide or a salt thereof, (2) low-subs...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4965A61K47/38A61K47/32A61P31/16
Inventor 刘翠艳张红芬卜利超张伟玲白晶刘永进张园园
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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