LIQUID COMPOSITION STABILIZING BOTULINUM TOXIN Russian patent published in 2024 - IPC A61K9/08 A61K38/48 A61K47/18 A61K47/20 A61K47/26 

FIELD: medicine.

SUBSTANCE: group of inventions relates to a liquid composition for use in stabilizing botulinum toxin, containing (i) polysorbate 80 and serine or (ii) polysorbate 80, serine and methionine as active ingredients, where (i) the ratio of polysorbate 80 : serine is 1 mg/ml : 5 mM or more, or (ii) the polysorbate 80 : serine: methionine ratio is 1 mg/ml : 5–50 mm : 0.2 mM, and where the composition contains 0.001 mg/ml or more of polysorbate 80 by 40 U/ml botulinum toxin, also refers to a pharmaceutical composition made in liquid dosage form for blocking the presynaptic release of acetylcholine containing the liquid composition and botulinum toxin in as active ingredients, also refers to a method of stabilizing botulinum toxin, comprising the following: mixing a liquid composition containing (i) polysorbate 80 and serine or (ii) polysorbate 80, serine and methionine, with botulinum toxin, where (i) the ratio is polysorbate 80 : serine is 1 mg/ml : 5 mM or more, or (ii) the polysorbate 80 : serine: methionine ratio is 1 mg/ml : 5–50 mm : 0.2 mM, and where the composition contains 0.001 mg/ml or more of polysorbate 80 per 40 U/ml botulinum toxin, and also refers to the use of a liquid composition containing (i) polysorbate 80 and serine or (ii) polysorbate 80, serine and methionine, to stabilize botulinum toxin, where (i) the polysorbate 80 : serine ratio is 1 mg/ml: 5 mM or more, or (ii) the polysorbate 80 : serine: methionine ratio is 1 mg/ml : 5–50 mm : 0.2 mM, and where the composition contains 0.001 mg/ml or more of polysorbate 80 per 40 U/ml botulinum toxin.

EFFECT: group of inventions provides a liquid composition containing a stabilizer that is not derived from an animal source, and thus, a patient who is administered a pharmaceutical composition containing botulinum toxin can be guaranteed safety from the potential risk of infection by a blood-derived pathogen or infectious microorganism, and ensuring stability during storage and distribution, since the activity of botulinum toxin is maintained at room temperature for a long time.

8 cl, 4 tbl, 3 dwg