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RU2018142149A - Жидкая композиция нейротоксина, стабилизированная триптофаном или тирозином - Google Patents

Жидкая композиция нейротоксина, стабилизированная триптофаном или тирозином Download PDF

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RU2018142149A
RU2018142149A RU2018142149A RU2018142149A RU2018142149A RU 2018142149 A RU2018142149 A RU 2018142149A RU 2018142149 A RU2018142149 A RU 2018142149A RU 2018142149 A RU2018142149 A RU 2018142149A RU 2018142149 A RU2018142149 A RU 2018142149A
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liquid composition
composition according
botulinum neurotoxin
wrinkles
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RU2018142149A
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RU2741497C9 (ru
RU2741497C2 (ru
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Андерс Ярстад
Анна Фриис
Ульф Шталь
Анн Гурелль
Барбро Агрен
Эмилия Эдстром
Эндрю Пикетт
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Ипсен Биофарм Лимитед
Нестле Скин Хелс Са
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Claims (35)

1. Жидкая композиция, содержащая белковый нейротоксин, поверхностно-активное вещество, аминокислоту, выбранную из триптофана и тирозина, буфер, включающий ионы натрия, хлорид-ионы и фосфат-ионы,
где указанная жидкая композиция имеет величину рН от 5,5 до 8,
где указанная композиция не содержит белков животного происхождения, и
где указанная жидкая композиция стабильна в течение продолжительного времени.
2. Жидкая композиция по п. 1, где поверхностно-активное вещество является неионным поверхностно-активным веществом.
3. Жидкая композиция по п. 2, где неионное поверхностно-активное вещество представляет собой полисорбат, предпочтительно Полисорбат 20, Полисорбат 60 или Полисорбат 80.
4. Жидкая композиция по любому из пп. 1-3, где аминокислота представляет собой триптофан, предпочтительно L-триптофан.
5. Жидкая композиция по любому из пп. 1-4, где буфер дополнительно включает ионы калия.
6. Жидкая композиция по любому из пп. 1-5, где указанная композиция имеет величину рН от 6,0 до 7,5.
7. Жидкая композиция по любому из пп. 1-6, где не более 30% внеклеточной протеолитической активности теряется в течение 2, 3, 6, 12, 18, 24 или 36 месяцев при температуре 5°С.
8. Жидкая композиция по любому из пп. 1-7, где белковый нейротоксин является ботулиническим нейротоксином, выбранным из природного ботулинического нейротоксина в форме комплекса, природного ботулинического нейротоксина высокой чистоты и рекомбинантного ботулинического нейротоксина.
9. Жидкая композиция по п. 8, где ботулинический нейротоксин представляет собой рекомбинантный ботулинический нейротоксин, выбранный из ботулинического нейротоксина типов А, В, С, D, Е, F или G, модифицированного ботулинического нейротоксина и химерного ботулинического нейротоксина.
10. Жидкая композиция по любому из пп. 1-9, где указанная жидкая композиция содержит:
- от 4 до 10000 единиц LD50 ботулинического нейротоксина на 1 мл,
- от 0,001 до 15 об. % полисорбата,
- от 0,1 до 5 мг/мл триптофана,
- от 10 до 500 мМ NaCl,
- от 1 до 50 мМ KCl,
- от 1 до 100 мМ фосфата натрия,
имеет величину рН в диапазоне от 5,5 до 8 и стабильна в течение 6 месяцев при температуре 5°С.
11. Жидкая композиция по п. 10, где указанная жидкая композиция содержит:
- от 10 до 2000 единиц LD50 ботулинического нейротоксина на 1 мл,
- от 0,05 до 0,2 об. % полисорбата 80,
- от 0,1 до 5 мг/мл триптофана,
- от 25 до 300 мМ NaCl,
- от 1 до 10 мМ KCl,
- от 2 до 50 мМ фосфата натрия,
имеет величину рН в диапазоне от 6,0 до 7,5 и стабильна в течение 12 месяцев при температуре 5°С.
12. Жидкая композиция по любому из пп. 1-11 для применения в терапии.
13. Жидкая композиция по п. 12 для применения для лечения или профилактики мышечных заболеваний, нейромышечных заболеваний, неврологических заболеваний, офтальмологических заболеваний, болевых состояний, психологических расстройств, заболеваний суставов, воспалительных заболеваний, эндокринных нарушений или урологических заболеваний.
14. Применение жидкой композиции по любому из пп. 1-11 в эстетической медицине, например, для лечения или профилактики появления морщин кожи, в частности, морщин лица, таких как лицевые межбровные складки, морщины контура глаз, глабеллярные морщины, опущение уголков рта, морщины шеи (платизмальные тяжи), морщины подбородка (подбородочная мышца, "апельсиновая корка", подбородок с ямочкой), морщины лба, морщины типа "поцарапанной кожи", лифтинг носа или складки после сна.
15. Применение аминокислоты, выбранной из триптофана и тирозина, для защиты белкового нейротоксина от разрушения в жидкой композиции, не содержащей белков животного происхождения.
16. Применение по п. 15, где аминокислота является триптофаном.
17. Применение по п. 15 или 16, где белковый нейротоксин является ботулинический нейротоксином.
18. Применение по п. 15, где аминокислоту используют в сочетании с поверхностно-активным веществом и буфером, включающим ионы натрия, хлорид-ионы и фосфат-ионы, при этом указанная жидкая композиция имеет величину рН от 5,5 до 8.
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