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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Authors
Dates
2021-05-28—Published
2017-08-28—Filed