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A kind of favipiravir granule preparation and preparation method thereof

A technology of Lavir granules and granule preparations, which is applied in the field of medicine, can solve the problems that tablets are difficult to swallow, and achieve the effects of good suspension effect, improved taste and prolonged residence time

Active Publication Date: 2021-10-15
AC PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Purpose of the invention: In order to solve the technical problems existing in the prior art, the present invention provides a favipiravir granule preparation and a preparation method thereof, which solves the problem that tablets on the market are difficult to swallow, and the prepared granule preparation is convenient for children and elderly patients to take. Good suspension effect, good taste, fast dissolution, simple preparation process

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～4

[0057] The used prescription and prescription consumption of embodiment 1-4 are as shown in table 1 below:

[0058] Table 1

[0059] Component classification name Example 1 Example 2 Example 3 Example 4 parts by weight parts by weight parts by weight parts by weight Main drug Favipiravir 200 200 200 200 filler dextrin 0 200 500 100 suspending agent Tragacanth Gum 10 50 100 150 sweetener sucrose 2000 1300 800 0 sweetener aspartame 0 20 40 80 pH regulator citric acid 1 50 70 120 pH regulator Sodium citrate 10 75 30 20 Glidant Micropowder silica gel 50 50 50 20 Batch / gram 300 300 300 300 Main drug particle size / micron 9.4 38 29 12 Granule formulation pH 5.8 4.9 3.5 2.3 Sedimentation volume ratio 0.91 0.94 0.95 0.96 Taste score 3.1 points 3.7 points 4.3 points 3.5 points

[0060] From the above resu...

Embodiment 1

[0061] Embodiment 1 preparation process steps:

[0062] 1) Favipiravir is subjected to airflow pulverization, the materials are collected, the particle size distribution is measured and controlled, and the D90 is obtained as a bulk drug of 9.4 microns;

[0063] 2) Pass tragacanth gum, sucrose, and micropowdered silica gel through a 60-mesh sieve respectively, and set aside;

[0064] 3) Mix the materials of step 1) and step 2) together in a mixer for 20 minutes to obtain the favipiravir granule formulation.

Embodiment 2～4

[0065] Embodiment 2~4 preparation process steps:

[0066] 1) Favipiravir is subjected to airflow pulverization, the material is collected, and the particle size distribution D90 is measured and controlled to be less than 40 microns;

[0067] 2) Pass the components other than the bulk drug through a 40-mesh sieve respectively, and set aside;

[0068] 3) Mix the other materials except micropowder silica gel and aspartame in step 1) and step 2) in a high-shear granulator, and then add the solution prepared by aspartame and purified water and continue stirring. Get the soft material with suitable wetting degree;

[0069] 4) the soft material of step 3) is carried out wet granulation by using a swing granulator with 40 meshes;

[0070] 5) The material obtained in step 4) is dried, and the obtained dried granules are dry granulated using a 40-mesh screen with an aperture;

[0071] 6) Mix the glidant and the granules obtained in step 5 in a mixer for 10 minutes to obtain the favip...

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Abstract

The invention discloses a favipiravir granule preparation, which comprises the following components in parts by weight: 200 parts by weight of favipiravir, 0-1000 parts by weight of filler, 10-200 parts by weight of suspending agent, flavoring 0.1-2000 parts by weight of agent, 0-100 parts by weight of glidant and an appropriate amount of pH regulator; wherein the particle size distribution of the favipiravir satisfies D90<40 microns; the pH value of the granular preparation is controlled by the pH regulator 2.0~6.0. By controlling the particle size of the bulk drug and the dosage of the suspending agent, the present invention can effectively ensure the uniform dispersion of the main drug in the clinical use process after being mixed with water, and provide a clinical preparation that is easy to swallow and has a flexible and adjustable dosage; further By controlling the pH range of the suspension prepared from the granule preparation, the influence of the unpleasant taste of the drug can be reduced. The invention solves the problem that the favipiravir tablets on the market are difficult to swallow, and the granule preparation is convenient for children and elderly patients to take, has good suspension effect, good taste, rapid dissolution and simple preparation process.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a favipiravir granule preparation and a preparation method thereof. Background technique [0002] Favipiravir (favipiravir), the chemical name is 6-fluoro-3-hydroxypyrazine-2-carboxamide, a new broad-spectrum anti-inflammatory drug targeting RNA-dependent RNA polymerase (RdRp) developed by Japan Toyama Chemical Pharmaceutical Co., Ltd. Viral drugs, approved for marketing in Japan in March 2014, are used to treat new and recurrent influenza. During the outbreak of the novel coronavirus, the results of the phase I clinical study of the drug released in March 2020 showed that the drug may slow the progression of the novel coronavirus pneumonia by accelerating virus clearance. [0003] The dosage form of favipiravir currently on the market is tablet, administered twice on the first day, 1600 mg each time; on the second to fifth day, twice a day, 600 mg each time. The dosage is v...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K47/36A61K31/4965A61P11/00A61P31/14A61P31/16
CPCA61K9/1652A61K9/1682A61K31/4965A61P11/00A61P31/14A61P31/16
Inventor 刘锋谭晓峰梁文伟周伟杰
Owner AC PHARMA CO LTD
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