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A kind of favipiravir tablet and preparation method thereof

The technology of lavir tablet and favipiravir, which is applied in the field of medicine, can solve the problems of decreased drug compliance, low fluidity, and no compression moldability, and achieves simple preparation process, good drug compliance, and good dissolution. Effect

Active Publication Date: 2020-01-17
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 disintegrant and excipient in this prescription is more expensive. For example, the LH-1 purchased from Xinyue Chemical is about 380 yuan per kilogram, and the dosage is relatively large. Patients have A great economic burden. If croscarmellose sodium is used to replace low-substituted hydroxypropyl cellulose, a large amount of excipients needs to be added, and the tablet size becomes very large

Method used

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  • A kind of favipiravir tablet and preparation method thereof
  • A kind of favipiravir tablet and preparation method thereof
  • A kind of favipiravir tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Example 1 Selection of Favipiravir Tablet Excipients

[0037] Weigh a certain amount of favipiravir and each auxiliary material according to the prescription ratio in Table 1, sieve and mix 10 times, add water to make 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 press into tablets.

[0038] Table 1 Favipiravir tablet test results

[0039]

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

[0041] From the test results in the above table, it can be seen that using microcrystalline cellulose as an excipient and disintegrant, in order to prepare tablets of acceptable quality (for example, suitable hardness, low friability, and acceptable dissolution), the size of the tablet to be prepared is required. It is very large; using silicified microcrystalline cellulose 50 and low-substituted hydroxypropyl cellulos...

Embodiment 4-13

[0042] Example 4-13 Favipiravir tablet binder, excipient dosage and tablet shape selection

[0043] Weigh a certain amount of favipiravir and each auxiliary material according to the prescription ratio in Table 2 and Table 3, sieve and mix 10 times, add water to make soft material, granulate with 32 mesh sieve, dry at 50 ℃, 32 mesh Sieve the granules, 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 a favipiravir tablet, which contains favipiravir, silicified microcrystalline cellulose and a binder. Compared with low-substituted hydroxypropyl cellulose, the price of silicified microcrystalline cellulose is lower , suitable size, good drug compliance, lower reject rate and better dissolution. The invention also relates to a preparation method of the tablet, which has a simple preparation process and is suitable for large-scale industrial 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, the chemical name is 6-fluoro-3-hydroxypyrazine-2-carboxamide, the original research company is Toyama Chemical Industry Co., Ltd. It was listed in Japan in July 2011 for the treatment of new or Recurrent influenza virus infection (limited to use when other anti-influenza virus drugs are ineffective or ineffective). [0003] Favipiravir itself does not have the properties of compression molding, large specific volume, strong cohesion, low fluidity, etc., resulting in a larger diameter of the prepared tablet and a decrease in drug compliance. In order to overcome this defect, patent CN102348458A discloses A tablet containing (1) 6-fluoro-3-hydroxy-2-pyrazinecarboxamide or a salt thereof, (2) low-substituted hydroxypropyl cellulose or croscarmellose sodium, and ( 3) an ...

Claims

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Application Information

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Patent Type & Authority Patents(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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