RU2018123197A - Композиция, содержащая ботулинический токсин - Google Patents

Композиция, содержащая ботулинический токсин Download PDF

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RU2018123197A
RU2018123197A RU2018123197A RU2018123197A RU2018123197A RU 2018123197 A RU2018123197 A RU 2018123197A RU 2018123197 A RU2018123197 A RU 2018123197A RU 2018123197 A RU2018123197 A RU 2018123197A RU 2018123197 A RU2018123197 A RU 2018123197A
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botulinum neurotoxin
composition
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RU2018123197A
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RU2018123197A3 (ru
RU2743746C2 (ru
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Клаус ФИНК
Гарольд ТЭЙЛОР
Герман РУСС
Петер БОДЕРКЕ
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Мерц Фарма Гмбх Энд Ко. Кгаа
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/726Glycosaminoglycans, i.e. mucopolysaccharides
    • A61K31/728Hyaluronic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/4886Metalloendopeptidases (3.4.24), e.g. collagenase
    • A61K38/4893Botulinum neurotoxin (3.4.24.69)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/64Proteins; Peptides; Derivatives or degradation products thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/72Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/73Polysaccharides
    • A61K8/735Mucopolysaccharides, e.g. hyaluronic acid; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00Drugs for disorders of the muscular or neuromuscular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61QSPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00Preparations for care of the skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61QSPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00Preparations for care of the skin
    • A61Q19/08Anti-ageing preparations
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/80Process related aspects concerning the preparation of the cosmetic composition or the storage or application thereof
    • A61K2800/91Injection
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Proteomics, Peptides & Aminoacids (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Gerontology & Geriatric Medicine (AREA)
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  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Molecular Biology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Cosmetics (AREA)

Claims (24)

1. Композиция для предотвращения или лечения дистонии, спастического состояния или морщин, содержащая
a) ботулинический нейротоксин
b) несшитую гиалуроновую кислоту, имеющую среднюю молекулярную массу от 2,5 МДа до 4,5МДа.
2. Композиция по п. 1, отличающаяся тем, что ботулинический нейротоксин представляет собой ботулинический нейротоксин типа А.
3. Композиция по п. 1 или 2, отличающаяся тем, что индекс полидисперсности несшитой гиалуроновой кислоты составляет от 1,1 до 4,0.
4. Композиция по любому из предшествующих пунктов, содержащая от 2 до 4 единиц ботулинического нейротоксина или от 20 до 40 единиц ботулинического нейротоксина на миллиграмм несшитой гиалуроновой кислоты.
5. Композиция по любому из предшествующих пунктов, отличающаяся тем, что указанная композиция дополнительно содержит
c) соль,
d) необязательно агент для стабилизации нейротоксина,
e) ингибитор кристаллизации,
f) буфер и/или
g) агент для удаления свободных радикалов.
6. Композиция по любому из предшествующих пунктов, при этом указанная композиция имеет динамическую вязкость от 1,5 до 4 Па⋅с, определенную при 25°С с применением частоты колебаний, составляющей 1 Гц.
7. Применение композиции по любому из пп. 1-6 для лечения или предотвращения дистонии, при котором вводят от 200 до 500 единиц ботулинического нейротоксина.
8. Применение композиции по любому из пп. 1-6 для лечения или предотвращения спастического состояния, при котором вводят от 500 до 1000 единиц ботулинического нейротоксина.
9. Применение композиции по любому из пп. 1-6 для предотвращения или лечения морщин, при котором вводят от 40 до 50 единиц ботулинического нейротоксина.
10. Применение по любому из пп. 7-9, отличающаяся тем, что указанная композиция остается в месте введения не более 24 часов после введения.
11. Применение по любому из пп. 7-9, отличающаяся тем, что ботулинический нейротоксин высвобождается в течение 12 часов.
12. Применение по любому из пп. 7-9, отличающаяся тем, что указанную композицию вводят каждые 4-9 месяцев.
13. Способ косметического разглаживания или предотвращения морщин у млекопитающего, при этом указанный способ включает:
(i) введение композиции по пп. 1-6, и
(и) повторение введения через 4-9 месяцев.
14. Способ по п. 13, отличающийся тем, что указанная композиция содержит от 40 до 50 единиц ботулинического нейротоксина.
15. Способ по любому из п. 13 или 14, отличающийся тем, что морщины обусловлены мимической активностью.
RU2018123197A 2016-03-02 2017-02-28 Композиция, содержащая ботулинический токсин RU2743746C2 (ru)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP16158302.6 2016-03-02
EP16158302 2016-03-02
PCT/EP2017/054596 WO2017148915A1 (en) 2016-03-02 2017-02-28 Composition comprising botulinum toxin

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RU2018123197A true RU2018123197A (ru) 2020-04-02
RU2018123197A3 RU2018123197A3 (ru) 2020-04-13
RU2743746C2 RU2743746C2 (ru) 2021-02-25

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US (1) US11969461B2 (ru)
EP (1) EP3423084B1 (ru)
JP (2) JP2019507118A (ru)
KR (1) KR20180114891A (ru)
CN (1) CN108463242A (ru)
AU (1) AU2017227978B2 (ru)
BR (1) BR112018014445A2 (ru)
CA (1) CA3010146A1 (ru)
ES (1) ES2893838T3 (ru)
MX (1) MX2018008855A (ru)
RU (1) RU2743746C2 (ru)
SG (1) SG11201805195YA (ru)
WO (1) WO2017148915A1 (ru)

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MX2018008855A (es) 2018-11-29
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AU2017227978A1 (en) 2018-07-19
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US20190060422A1 (en) 2019-02-28
JP2019507118A (ja) 2019-03-14
US11969461B2 (en) 2024-04-30
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WO2017148915A1 (en) 2017-09-08
CN108463242A (zh) 2018-08-28
JP2022130574A (ja) 2022-09-06
ES2893838T3 (es) 2022-02-10
KR20180114891A (ko) 2018-10-19
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