RU2018142149A - Жидкая композиция нейротоксина, стабилизированная триптофаном или тирозином - Google Patents
Жидкая композиция нейротоксина, стабилизированная триптофаном или тирозином Download PDFInfo
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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
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- botulinum neurotoxin
- wrinkles
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- 239000007788 liquid Substances 0.000 title claims 21
- 101710138657 Neurotoxin Proteins 0.000 title claims 5
- OUYCCCASQSFEME-QMMMGPOBSA-N L-tyrosine Chemical compound OC(=O)[C@@H](N)CC1=CC=C(O)C=C1 OUYCCCASQSFEME-QMMMGPOBSA-N 0.000 title claims 3
- OUYCCCASQSFEME-UHFFFAOYSA-N tyrosine Natural products OC(=O)C(N)CC1=CC=C(O)C=C1 OUYCCCASQSFEME-UHFFFAOYSA-N 0.000 title claims 3
- 239000002581 neurotoxin Substances 0.000 title 1
- 231100000618 neurotoxin Toxicity 0.000 title 1
- 108030001720 Bontoxilysin Proteins 0.000 claims 12
- 231100001103 botulinum neurotoxin Toxicity 0.000 claims 12
- 230000037303 wrinkles Effects 0.000 claims 9
- QIVBCDIJIAJPQS-VIFPVBQESA-N L-tryptophane Chemical compound C1=CC=C2C(C[C@H](N)C(O)=O)=CNC2=C1 QIVBCDIJIAJPQS-VIFPVBQESA-N 0.000 claims 8
- 229960004799 tryptophan Drugs 0.000 claims 7
- QIVBCDIJIAJPQS-UHFFFAOYSA-N Tryptophan Natural products C1=CC=C2C(CC(N)C(O)=O)=CNC2=C1 QIVBCDIJIAJPQS-UHFFFAOYSA-N 0.000 claims 6
- 150000001413 amino acids Chemical class 0.000 claims 5
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 4
- 239000004094 surface-active agent Substances 0.000 claims 3
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 claims 2
- 230000001815 facial effect Effects 0.000 claims 2
- 239000002736 nonionic surfactant Substances 0.000 claims 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims 2
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 2
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 2
- 229920000136 polysorbate Polymers 0.000 claims 2
- 229950008882 polysorbate Drugs 0.000 claims 2
- 229920000053 polysorbate 80 Polymers 0.000 claims 2
- 229940068968 polysorbate 80 Drugs 0.000 claims 2
- 239000011780 sodium chloride Substances 0.000 claims 2
- 229910001415 sodium ion Inorganic materials 0.000 claims 2
- 239000001488 sodium phosphate Substances 0.000 claims 2
- 229910000162 sodium phosphate Inorganic materials 0.000 claims 2
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 claims 2
- 208000017701 Endocrine disease Diseases 0.000 claims 1
- 208000012659 Joint disease Diseases 0.000 claims 1
- 208000029578 Muscle disease Diseases 0.000 claims 1
- 208000012902 Nervous system disease Diseases 0.000 claims 1
- 208000025966 Neurological disease Diseases 0.000 claims 1
- 229920001213 Polysorbate 20 Polymers 0.000 claims 1
- 229920001214 Polysorbate 60 Polymers 0.000 claims 1
- 208000012931 Urologic disease Diseases 0.000 claims 1
- 235000021120 animal protein Nutrition 0.000 claims 1
- 230000015556 catabolic process Effects 0.000 claims 1
- 238000006731 degradation reaction Methods 0.000 claims 1
- 201000010099 disease Diseases 0.000 claims 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 210000004709 eyebrow Anatomy 0.000 claims 1
- 210000001061 forehead Anatomy 0.000 claims 1
- 208000027866 inflammatory disease Diseases 0.000 claims 1
- 210000003205 muscle Anatomy 0.000 claims 1
- 208000018360 neuromuscular disease Diseases 0.000 claims 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 1
- 239000001818 polyoxyethylene sorbitan monostearate Substances 0.000 claims 1
- 235000010989 polyoxyethylene sorbitan monostearate Nutrition 0.000 claims 1
- 229940068977 polysorbate 20 Drugs 0.000 claims 1
- 229940113124 polysorbate 60 Drugs 0.000 claims 1
- 229910001414 potassium ion Inorganic materials 0.000 claims 1
- 230000002265 prevention Effects 0.000 claims 1
- 235000018102 proteins Nutrition 0.000 claims 1
- 108090000623 proteins and genes Proteins 0.000 claims 1
- 102000004169 proteins and genes Human genes 0.000 claims 1
- 230000002797 proteolythic effect Effects 0.000 claims 1
- 208000020016 psychiatric disease Diseases 0.000 claims 1
- 238000002560 therapeutic procedure Methods 0.000 claims 1
- 208000014001 urinary system disease Diseases 0.000 claims 1
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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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| PCT/EP2017/062785 WO2017203038A1 (en) | 2016-05-27 | 2017-05-26 | Liquid neurotoxin formulation stabilized with tryptophan or tyrosine |
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| KR101975051B1 (ko) | 2009-06-25 | 2019-05-03 | 레반스 테라퓨틱스, 아이엔씨. | 알부민불포함 보툴리눔 독소 제제 |
| US9480731B2 (en) | 2013-12-12 | 2016-11-01 | Medy-Tox, Inc. | Long lasting effect of new botulinum toxin formulations |
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| RU2020123346A (ru) * | 2017-12-20 | 2022-01-20 | Аллерган, Инк. | Полипептиды клеточносвязывающего домена ботулинического токсина и способы применения для лечения расстройств, связанных с фиброзом |
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| GEAP202416580A (en) * | 2022-01-14 | 2024-11-25 | Ipsen Biopharm Ltd | Treatment of moderate to very severe glabellar lines and lateral canthal lines |
| JP2025504249A (ja) * | 2022-02-15 | 2025-02-06 | メルツ・ファルマ・ゲーエムベーハー・ウント・コー・カーゲーアーアー | 液体ボツリヌス毒素製剤及びその使用 |
| TW202525330A (zh) | 2023-08-10 | 2025-07-01 | 德商梅茲製藥有限兩合公司 | 液體肉毒桿菌毒素製劑及其製作方法 |
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