Liquid composition containing botulinum toxin and a stabilizing agent, and a method for its preparation Russian patent published in 2021 - IPC A61K9/08 A61K31/167 A61K38/48 A61K47/08 A61K47/12 A61K47/18 A61K47/26 

Abstract RU 2748653 C2

FIELD: medicine; pharmaceuticals.

SUBSTANCE: present invention relates to a liquid composition for the stabilization of botulinum toxin, containing botulinum toxin, the first stabilizing agent and the second stabilizing agent, wherein the first stabilizing agent is arginine with a concentration equal to 50 mM, the second stabilizing agent is glutamic acid or aspartic acid, while the concentration of the second stabilizing agent is from 10 to 50 mM. Also, the present invention relates to a method for producing a liquid composition for stabilizing botulinum toxin according to claim 1, containing the steps: (a) purification of botulinum toxin; and (b) addition of the first stabilizing agent and the second stabilizing agent to the specified botulinum toxin, wherein the first stabilizing agent is arginine with a concentration equal to 50 mM, the second stabilizing agent is glutamic acid or aspartic acid, while the concentration of the second stabilizing agent is from 10 to 50 mM.

EFFECT: creation of a liquid pharmaceutical composition containing botulinum toxin and a stabilizing agent, wherein the stabilizing agent prevents the denaturation of the protein during its production and distribution in the form of a liquid composition of botulinum toxin, as well as during its storage, distribution and handling.

11 cl, 2 ex, 5 tbl, 12 dwg

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RU 2 748 653 C2

Authors

Lee, Chee Gun

Oum, Ji Khyun

Dates

2021-05-28Published

2017-08-28Filed