Favipiravir pharmaceutical composition containing different particle size ranges

A favipiravir and composition technology, which is applied in the field of favipiravir pharmaceutical compositions, can solve problems such as inability to measure dissolution rate, impact, and poor solubility of favipiravir, so as to improve the bioavailability of human body and quickly release effect

Active Publication Date: 2015-01-21
CHENGDU SINO STRONG PHARMA +1
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Chinese patent CN102348458B discloses a useful tablet containing a high content of favipiravir or its salt, and the dissolution rate of favipiravir cannot be measured in acetate buffer (pH4.5), proving again that the compound is Solubility affects the dissolution rate of its formulation
From these patent applications, it can be seen that the solubility of faraprevir in water is very poor

Method used

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  • Favipiravir pharmaceutical composition containing different particle size ranges
  • Favipiravir pharmaceutical composition containing different particle size ranges

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Sampling according to prescription 1, jet milling Favipiravir, collecting materials, and measuring particle size distribution (dry method measurement), requiring D10=0.1~8 microns, D50=10~30 microns, D90<50 microns. The lactose monohydrate, microcrystalline cellulose, and corn starch are pulverized to control the particle size distribution D90<75 microns respectively. Mix lactose monohydrate, microcrystalline cellulose, and cornstarch in multiple mobile mixers for 20 minutes, take 10 samples from different positions of the mixer, and measure the material uniformity. The RSD value is required to be less than 1.0%. Put the material that meets the requirements on the dry granulator, adjust the rotation speed of the extrusion wheel (3.6~5.3rpm), the rotation speed of the feeding screw (12~24rpm), the pressure of the oil cylinder (the pressure of the oil cylinder is 1.0 MPa~3.0 MPa), so that it can be three Those who cooperate effectively until the hardness of the pressed me...

Embodiment 2-4

[0042] Sampling according to prescription 2-4, method is the same as embodiment 1.

Embodiment 5

[0044] Dissolution test of Favipiravir in water

[0045] Dissolution test method: paddle method, 50 rpm, 900ml of water and acetate buffer (pH4.5). Measured by UV method, the wavelength is 323nm, and the concentration of the reference substance is about 8μg / ml.

[0046] From figure 1 It can be seen that at 15 minutes, the cumulative stripping is less than 50%, and only about 70% at 60 minutes, which is very different from the stripping of more than 95% in 15 minutes in the patent literature.

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PUM

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Abstract

The invention discloses a favipiravir pharmaceutical composition containing different particle size ranges. According to special particle size distribution and preparation process, the problem of dissolution rate of favipiravir preparations in water is solved, the favipiravir is rapidly released, the human bioavailability is provided, and the problems that the dissolution rate of favipiravir in the preparation is limited, in-vivo absorption is influenced and the clinical treatment aim is achieved due to different pH value environments are solved. The invention also provides a method for preparing the favipiravir pharmaceutical composition.

Description

technical field [0001] The invention relates to a favipiravir pharmaceutical composition containing different particle size ranges, belonging to the field of pharmaceutical preparations. Background technique [0002] Favipiravir, whose chemical name is 6-fluoro-3-hydroxypyrazine-2-carboxamide, is a new type of RNA polymerase inhibitor developed by Japan Toyama Chemical Pharmaceutical Company. In March 2011, Phase III clinical trials were completed in Japan, and a marketing application was submitted, which can be used clinically to treat influenza. [0003] The solubility of Favipiravir in water is slightly soluble, and it is also slightly soluble in different pH ranges. Chinese patent CN102348458B discloses a useful tablet containing a high content of favipiravir or its salt, and the dissolution rate of favipiravir cannot be measured in acetate buffer (pH4.5), proving again that the compound is Solubility affects the dissolution rate of its formulation. [0004] Chinese p...

Claims

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Application Information

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IPC IPC(8): A61K31/4965A61K47/38A61P31/16
CPCA61K31/4965A61K47/38
Inventor 蒲洪陈小宁许娟
Owner CHENGDU SINO STRONG PHARMA
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