RU2011125601A - Фармацевтические композиции токсина клостридий - Google Patents

Фармацевтические композиции токсина клостридий Download PDF

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RU2011125601A
RU2011125601A RU2011125601/15A RU2011125601A RU2011125601A RU 2011125601 A RU2011125601 A RU 2011125601A RU 2011125601/15 A RU2011125601/15 A RU 2011125601/15A RU 2011125601 A RU2011125601 A RU 2011125601A RU 2011125601 A RU2011125601 A RU 2011125601A
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composition
excipient
composition according
effective amount
clostridial toxin
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RU2535003C2 (ru
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Гопал ДАСАРИ
Ананда СЕНЕВИРАТНЕ
Джек З. КСИ
Хуон Т. ТРЭН
Алекс ПРЭСЬЮТ
Дон МЭТЬЮСОН
Терренс Джей ХАНТ
Нэриш П.М. КУМАР
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Аллерган, Инк.
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    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/4886—Metalloendopeptidases (3.4.24), e.g. collagenase
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/4886—Metalloendopeptidases (3.4.24), e.g. collagenase
    • A61K38/4893—Botulinum neurotoxin (3.4.24.69)
    • A—HUMAN NECESSITIES
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
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    • A61K9/19—Particulate 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
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    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/24—Metalloendopeptidases (3.4.24)

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  • Peptides Or Proteins (AREA)
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Abstract

1. He содержащая животный белок фармацевтическая композиция клостридиального токсина в твердой форме, содержащая клостридиальный токсин в качестве активного ингредиента, эффективное количество эксципиента сахара и эффективное количество поверхностно-активного эксципиента.2. Композиция по п.1, где эксципиент сахар представляет собой моносахарид, дисахарид или трисахарид.3. Композиция по п.1, где моносахарид представляет собой сахарозу или трегалозу.4. Композиция по п.1, где поверхностно-активный эксципиент представляет собой полоксамер, полисорбат, полиоксиэтиленгликольдодециловый эфир или полиоксиэтиленоктилфениловый эфир.5. Композиция по п.1, где клостридиальный токсин в качестве активного ингредиента стабилен в течение по меньшей мере одного года при хранении при температуре окружающей среды или ниже температуры замерзания.6. Композиция по п.1, где композиция забуферена до рН от приблизительно 5,5 до приблизительно 6,5.7. Композиция по п.6, где композиция забуферена с использованием цитратного буфера, фосфатного буфера, гистидинового буфера или гистидин-фосфатного буфера.8. Композиция по п.1, где композиция дополнительно содержит эффективное количество хлорида натрия.9. Композиция по п.1, где композиция дополнительно содержит эффективное количество небелкового полимерного эксципиента.10. Композиция по п.9, где небелковый полимерный эксципиент представляет собой декстран, полиэтиленгликоль, полиэтиленимин, поливинилпирролидон, поливинилацетат, инулин, крахмал или производное крахмала.

Claims (10)

1. He содержащая животный белок фармацевтическая композиция клостридиального токсина в твердой форме, содержащая клостридиальный токсин в качестве активного ингредиента, эффективное количество эксципиента сахара и эффективное количество поверхностно-активного эксципиента.
2. Композиция по п.1, где эксципиент сахар представляет собой моносахарид, дисахарид или трисахарид.
3. Композиция по п.1, где моносахарид представляет собой сахарозу или трегалозу.
4. Композиция по п.1, где поверхностно-активный эксципиент представляет собой полоксамер, полисорбат, полиоксиэтиленгликольдодециловый эфир или полиоксиэтиленоктилфениловый эфир.
5. Композиция по п.1, где клостридиальный токсин в качестве активного ингредиента стабилен в течение по меньшей мере одного года при хранении при температуре окружающей среды или ниже температуры замерзания.
6. Композиция по п.1, где композиция забуферена до рН от приблизительно 5,5 до приблизительно 6,5.
7. Композиция по п.6, где композиция забуферена с использованием цитратного буфера, фосфатного буфера, гистидинового буфера или гистидин-фосфатного буфера.
8. Композиция по п.1, где композиция дополнительно содержит эффективное количество хлорида натрия.
9. Композиция по п.1, где композиция дополнительно содержит эффективное количество небелкового полимерного эксципиента.
10. Композиция по п.9, где небелковый полимерный эксципиент представляет собой декстран, полиэтиленгликоль, полиэтиленимин, поливинилпирролидон, поливинилацетат, инулин, крахмал или производное крахмала.
RU2011125601/15A 2008-12-10 2009-12-10 Фармацевтические композиции токсина клостридий RU2535003C2 (ru)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US12134508P 2008-12-10 2008-12-10
US12/331,816 US8168206B1 (en) 2005-10-06 2008-12-10 Animal protein-free pharmaceutical compositions
US12/331,816 2008-12-10
US61/121,345 2008-12-10
PCT/US2009/067538 WO2010090677A1 (en) 2008-12-10 2009-12-10 Clostridial toxin pharmaceutical compositions

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RU2011125601A true RU2011125601A (ru) 2013-01-20
RU2535003C2 RU2535003C2 (ru) 2014-12-10

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EP (2) EP2373294B1 (ru)
JP (5) JP2012512162A (ru)
KR (2) KR20110106346A (ru)
CN (2) CN102307571A (ru)
AU (1) AU2009339292B2 (ru)
CA (1) CA2746425C (ru)
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CN105833254A (zh) 2016-08-10
WO2010090677A1 (en) 2010-08-12
JP2012512162A (ja) 2012-05-31
AU2009339292A1 (en) 2011-07-07
JP6424135B2 (ja) 2018-11-14
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CA2746425C (en) 2016-05-03
EP2373294A1 (en) 2011-10-12
AU2009339292B2 (en) 2016-01-21
JP2019108381A (ja) 2019-07-04
KR20160103551A (ko) 2016-09-01
EP2373294B1 (en) 2016-04-20
RU2535003C2 (ru) 2014-12-10
JP2021113233A (ja) 2021-08-05
JP2015178505A (ja) 2015-10-08
JP2017186348A (ja) 2017-10-12
CN102307571A (zh) 2012-01-04
CA2746425A1 (en) 2010-08-12

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