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A fast-dissolving favipiravir pharmaceutical composition and preparation method

A favipiravir and composition technology, which is applied in the field of favipiravir pharmaceutical compositions, can solve the problems of poor production feasibility and achieve the effects of small tablet weight, improved bioavailability, and increased compressibility

Active Publication Date: 2021-08-31
ZHEJIANG HISUN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

And in the preparation process disclosed in the patent, the solubilizer (Example 1: Polysorbate 80, liquid) is mixed with Favipiravir in equal amounts, and microcrystalline cellulose 102 and crospovidone are passed through 100 mesh screen and other steps, the actual production feasibility of the invention is relatively poor

Method used

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  • A fast-dissolving favipiravir pharmaceutical composition and preparation method
  • A fast-dissolving favipiravir pharmaceutical composition and preparation method
  • A fast-dissolving favipiravir pharmaceutical composition and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043]

[0044]

[0045] Favipiravir is jet-milled to collect materials, requiring D90≤100 microns, D50=5-30 microns, and D10=0.1-8 microns. Weigh the crude drug and auxiliary materials according to the above prescription ratio, and pass through a 40-mesh sieve respectively. Put the raw material favipiravir and the auxiliary materials pregelatinized starch 1500, sodium starch glycolate, crospovidone XL-10, and micropowder silica gel (internal addition) in a multi-directional motion mixer for mixing for 15 minutes , mix the materials evenly. Put the above materials into the dry granulator, adjust the parameters of the feeding module and the rolling module respectively: the horizontal speed is 5rpm, the vertical speed setting is 100rpm, the roller gap is 2.0mm, and the roller pressure is 10±1KN / cm 2 . Within the above range, by adjusting the horizontal rotation speed, vertical rotation speed, roller gap, and roller pressure, the thin slices with appropriate hardness can ...

Embodiment 2

[0047]

[0048]

[0049] Favipiravir is jet-milled to collect materials, requiring D90≤100 microns, D50=5-30 microns, and D10=0.1-8 microns. Weigh the crude drug and auxiliary materials according to the above prescription ratio, and pass through a 40-mesh sieve respectively. All the other operations are the same as in Example 1.

Embodiment 3

[0051]

[0052] Favipiravir is jet-milled to collect materials, requiring D90≤100 microns, D50=5-30 microns, and D10=0.1-8 microns. Weigh the crude drug and auxiliary materials according to the above prescription ratio, and pass through a 40-mesh sieve respectively. All the other operations are the same as in Example 1.

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Abstract

The invention discloses a fast-dissolving favipiravir pharmaceutical composition. By controlling the particle size of the raw material drug and optimizing the combination of suitable auxiliary materials, the problem of the dissolution rate of the product in water is significantly improved, and the pharmaceutical composition can be rapidly dispersed and dissolved, improving Human bioavailability is beneficial for clinical therapeutic purposes. The invention also includes a preparation method of the fast-dissolving favipiravir pharmaceutical composition.

Description

technical field [0001] The invention relates to a fast-dissolving favipiravir pharmaceutical composition. It belongs to the field of pharmaceutical preparations. Background technique [0002] Favipiravir, whose chemical name is 6-fluoro-3-hydroxypyrazine-2-carboxamide, is a novel RNA-dependent RNA polymerase (RdRP) inhibitor class of anti-influenza virus drugs. Favipiravir was developed by Japan's Toyama Chemical Co., Ltd. It was first approved by the Japanese Ministry of Health and Welfare in March 2014 for new or recurrent influenza virus infections; the approved dosage form is a tablet. [0003] Favipiravir and its salts have the following properties: no compression moldability, large specific volume (small bulk density), strong cohesion, and low fluidity. [0004] When the cohesion of the powder is strong, the fluidity of the powder is poor, which will lead to uneven filling of the die during the tableting process, resulting in large differences in tablet weight and af...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4965A61K47/32A61K47/04A61K47/12A61K47/36A61P31/16
CPCA61K31/4965A61K47/32A61K47/02A61K47/36A61P31/16A61K47/14A61K9/1652A61K9/1635A61K9/1617A61K9/1611A61K9/28A61K9/2059A61K9/2027A61K9/2013A61K9/2009
Inventor 李慧谭奕陆神龙李宏杰高华
Owner ZHEJIANG HISUN PHARMA CO LTD
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