Freeze-dried preparation of favipiravir for injection and preparation method thereof

A technology of freeze-dried preparations and favipiravir, which is applied in the field of medicine, can solve problems such as defects in quality attributes, and achieve the effects of low water content, beautiful properties, and good pharmaceutical characteristics

Active Publication Date: 2020-06-05
REYOUNG PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] The object of the present invention is to provide a new formulation and preparation method of piravir freeze-dried preparations for injection, which can effectively solve the defects of key quality attributes of freeze-dried preparations in the prior art, especially insoluble particles, turbidity

Method used

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  • Freeze-dried preparation of favipiravir for injection and preparation method thereof
  • Freeze-dried preparation of favipiravir for injection and preparation method thereof
  • Freeze-dried preparation of favipiravir for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0076] 100 prescriptions

[0077]

[0078] Preparation

[0079] (1) Preparation of Favipiravir freeze-dried preparation intermediate solution

[0080] Add the prescribed amount of Favipiravir to 90% water for injection, control the temperature between 15-20°C, and form a suspension state, add tert-butanol therein, shear and stir until a clear solution is obtained. Then add sodium hydroxide, adjust the pH to 6.0-9.0, add water to the full amount, filter with a 0.2 μm polyethersulfone filter membrane, fill in 20ml vials, each bottle has a volume of 10ml; the vials are half-stoppered and placed in a freeze dryer. Freeze drying is carried out.

[0081] (2) Pre-freezing of Favipiravir freeze-dried preparation

[0082] Rapidly lower the temperature of the intermediate solution of the above-mentioned favipiravir freeze-dried preparation to -25~-50°C, and maintain it for 0.5~2h.

[0083] (3) Sublimation and analytical drying

[0084] Turn on the vacuum pump to evacuate. After ...

Embodiment 2

[0087] 100 prescriptions

[0088]

[0089] Preparation

[0090] (1) Preparation of Favipiravir freeze-dried preparation intermediate solution

[0091] Add the prescribed amount of Favipiravir to 90% water for injection, control the temperature between 25 and 35°C to form a suspension, add tert-butanol to it, and shear and stir until a clear solution is obtained. Then add sodium hydroxide, adjust the pH to 6.0-9.0, add water to the full amount, filter with a 0.2 μm polyethersulfone filter membrane, fill in 20ml vials, each bottle has a volume of 10ml; the vials are half-stoppered and placed in a freeze dryer. Freeze drying is carried out.

[0092] (2) Pre-freezing of Favipiravir freeze-dried preparation

[0093] Rapidly lower the temperature of the intermediate solution of the above-mentioned favipiravir lyophilized preparation to -35~-60°C, and maintain it for 2~4h.

[0094] (3) Sublimation and analytical drying

[0095] Turn on the vacuum pump to evacuate. After the v...

Embodiment 3

[0098] 100 prescriptions

[0099]

[0100]

[0101] Preparation

[0102](1) Preparation of Favipiravir freeze-dried preparation intermediate solution

[0103] Add the prescribed amount of Favipiravir to 90% water for injection, control the temperature between 20 and 25°C to form a suspension, add tert-butanol to it, and shear and stir until a clear solution is obtained. Then add sodium hydroxide, adjust the pH to 7.0-8.0, replenish the water to the full amount, filter with a 0.2 μm polyethersulfone filter membrane, fill in 20ml vials, and the volume of each bottle is 10ml; the vials are half-stoppered and placed in a freeze dryer. Freeze drying is carried out.

[0104] (2) Pre-freezing of Favipiravir freeze-dried preparation

[0105] Rapidly lower the temperature of the intermediate solution of the above-mentioned favipiravir lyophilized preparation to -35~-50°C, and maintain it for 2~5h.

[0106] (3) Sublimation and analytical drying

[0107] Turn on the vacuum pum...

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Abstract

The invention relates to a freeze-dried preparation of favipiravir for injection. A formula of the freeze-dried preparation specifically comprises an active component favipiravir, a pH regulator sodium hydroxide, an excipient mannitol, a freeze-drying additive tert-butyl alcohol, and water for injection. The invention also discloses a method for preparing the freeze-dried preparation of favipiravir for injection. With the method, quality defects, such as clarity, turbidity and the like, of the freeze-dried preparation caused by sublimation of favipiravir can be effectively controlled; and theprepared freeze-dried preparation has good stability.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a freeze-dried preparation of pilavir for injection and a preparation method thereof. Background technique [0002] Favipiravird (favipiravird), chemically named 6-fluoro-3-hydroxypyrazine-2-carboxamide, is a kind of RNA-dependent RNA polymerase inhibitor broad-spectrum antiviral developed by Toyama Chemical Industry Co., Ltd. The drug, launched in Japan in July 2011, is used to treat new or recurrent influenza virus infections. [0003] Favipiravir is shown in the following structural formula: [0004] [0005] It is already known that when the raw drug is formulated into a preparation, it is necessary to effectively endow the preparation with properties that meet the requirements for drug marketing, such as human acceptance and drug stability. [0006] The general preparation process of lyophilized preparations includes the following steps: preparation of lyophilized interm...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4965A61K47/10A61P31/16
CPCA61K9/19A61K9/0019A61K31/4965A61K47/10A61P31/16
Inventor 苗得足张光明李锋王振刘东铎廉康夫阚玉庚姜征叶翠红
Owner REYOUNG PHARMA
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