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UA97391C2 - Лиофилизированный препарат, содержащий гриппозную вакцину, и способ его получения - Google Patents

Лиофилизированный препарат, содержащий гриппозную вакцину, и способ его получения

Info

Publication number
UA97391C2
UA97391C2 UAA200910179A UAA200910179A UA97391C2 UA 97391 C2 UA97391 C2 UA 97391C2 UA A200910179 A UAA200910179 A UA A200910179A UA A200910179 A UAA200910179 A UA A200910179A UA 97391 C2 UA97391 C2 UA 97391C2
Authority
UA
Ukraine
Prior art keywords
influenza vaccine
preparation
aqueous solution
lyophilized preparation
iii
Prior art date
Application number
UAA200910179A
Other languages
English (en)
Ukrainian (uk)
Inventor
Тикамаса Ямасита
Original Assignee
Оцука Фармасьютикал Ко., Лтд.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Оцука Фармасьютикал Ко., Лтд. filed Critical Оцука Фармасьютикал Ко., Лтд.
Publication of UA97391C2 publication Critical patent/UA97391C2/ru

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • A61K39/145—Orthomyxoviridae, e.g. influenza virus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/16—Antivirals for RNA viruses for influenza or rhinoviruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2760/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011—Details
    • C12N2760/16011—Orthomyxoviridae
    • C12N2760/16034—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2760/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011—Details
    • C12N2760/16011—Orthomyxoviridae
    • C12N2760/16051—Methods of production or purification of viral material

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Virology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Mycology (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Pulmonology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oncology (AREA)
  • Molecular Biology (AREA)
  • Communicable Diseases (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

Лиофилизированный препарат, в котором гриппозная вакцина имеет повышенную стойкость, может быть получен лиофилизацией водного раствора, содержащей (i) гриппозную вакцину, (ii) гидрофобную аминокислоту и (iii) аргинин, и его кислотно-аддитивную соль; причем пропорция компонента (iii) аргинина и его кислотно-аддитивной соли относительно общего количества лиофилизированного препарата представляет от 20 до 85 % мас. относительно общего количества полученного в результате лиофилизированного препарата. рН раствора доводят до уровня от 8 до 10 путем регулирования пропорции аргинина и его кислотно-аддитивной соли, образовывающих компонент (iii).
UAA200910179A 2007-03-09 2008-03-07 Лиофилизированный препарат, содержащий гриппозную вакцину, и способ его получения UA97391C2 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2007059724 2007-03-09
PCT/JP2008/054210 WO2008111532A1 (ja) 2007-03-09 2008-03-07 インフルエンザワクチン含有凍結乾燥製剤、及びその製造方法

Publications (1)

Publication Number Publication Date
UA97391C2 true UA97391C2 (ru) 2012-02-10

Family

ID=39759470

Family Applications (1)

Application Number Title Priority Date Filing Date
UAA200910179A UA97391C2 (ru) 2007-03-09 2008-03-07 Лиофилизированный препарат, содержащий гриппозную вакцину, и способ его получения

Country Status (19)

Country Link
US (1) US8216588B2 (ru)
EP (1) EP2119451A4 (ru)
JP (1) JP5388842B2 (ru)
KR (1) KR20090128463A (ru)
CN (1) CN101631563B (ru)
AR (1) AR065640A1 (ru)
AU (1) AU2008225501B2 (ru)
BR (1) BRPI0808037A2 (ru)
CA (1) CA2680193C (ru)
IL (1) IL200588A0 (ru)
MX (1) MX2009009635A (ru)
MY (1) MY149924A (ru)
NZ (1) NZ579395A (ru)
RU (1) RU2484847C2 (ru)
SG (1) SG179406A1 (ru)
TW (1) TWI428140B (ru)
UA (1) UA97391C2 (ru)
WO (1) WO2008111532A1 (ru)
ZA (1) ZA200905952B (ru)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0614460D0 (en) * 2006-07-20 2006-08-30 Novartis Ag Vaccines
US11060068B2 (en) 2011-06-28 2021-07-13 Leukocare Ag Stabilisation method for viruses or bacteria
DK2948129T3 (da) * 2013-01-25 2018-01-29 Wintermute Biomedical Inc Terapeutiske forbindelser
GB201314248D0 (en) * 2013-08-08 2013-09-25 Glaxosmithkline Biolog Sa Saccharide vaccine formulation
RU2720808C2 (ru) * 2013-09-03 2020-05-13 Джорджия Тек Рисёч Корпорейшн Термостабильные препараты вакцин и микроиглы
EP3060247A1 (en) * 2013-10-25 2016-08-31 Leukocare Ag A novel method for the production of stabile vaccines
WO2017090767A1 (ja) * 2015-11-27 2017-06-01 日東電工株式会社 インフルエンザワクチン乾燥製剤、及び、インフルエンザワクチン乾燥製剤の製造方法
JP6916113B2 (ja) 2015-11-27 2021-08-11 日東電工株式会社 口腔内投与用ワクチン医薬組成物及び口腔内投与用ワクチン医薬組成物の製造方法
WO2017090769A1 (ja) * 2015-11-27 2017-06-01 日東電工株式会社 インフルエンザワクチン乾燥製剤、及び、インフルエンザワクチン乾燥製剤の製造方法
AU2018217906A1 (en) 2017-02-13 2019-08-15 Wintermute Biomedical, Inc. Anti-pathogenic therapeutic compositions
EP3860585A4 (en) 2018-10-01 2022-06-22 Wintermute Biomedical, Inc. Therapeutic compositions

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2505657A1 (fr) * 1981-05-13 1982-11-19 Pasteur Institut Perfectionnements apportes aux agents de stabilisation de virus vivants pour la preparation de vaccins, et vaccins stabilises contenant lesdits agents de stabilisation
US4537769A (en) * 1982-04-06 1985-08-27 American Cyanamid Company Stabilization of influenza virus vaccine
JPH07121871B2 (ja) * 1986-10-09 1995-12-25 国立予防衛生研究所長 インフルエンザワクチン凍結乾燥製剤
JPH05229960A (ja) * 1990-10-30 1993-09-07 Dai Ichi Seiyaku Co Ltd 新規インフルエンザワクチン
JPH0813753B2 (ja) 1992-05-22 1996-02-14 株式会社微生物化学研究所 牛伝染性鼻気管炎ウイルス感染症、牛ウイルス性下痢−粘膜病ウイルス感染症、パラインフルエンザ３型ウイルス感染症、牛ｒｓウイルス感染症および牛アデノ７型ウイルス感染症５種混合生ワクチン
MXPA02009485A (es) * 2000-03-31 2003-03-10 Kirin Brewery Preparacion en polvo para administracion a traves de la mucosa, que comprende un farmaco de alto peso molecular y que muestra una estabilidad mejorada en almacenamiento.
EG24184A (en) * 2001-06-15 2008-10-08 Otsuka Pharma Co Ltd Dry powder inhalation system for transpulmonary
JP2004054555A (ja) * 2002-07-19 2004-02-19 Yokogawa Electric Corp 表示装置
JP4617300B2 (ja) * 2003-02-25 2011-01-19 メディミューン，エルエルシー インフルエンザワクチン組成物を生成する方法
KR101346989B1 (ko) * 2004-10-06 2014-02-06 메디뮨 엘엘씨 냉장 온도 안정성 인플루엔자 백신 조성물
RU2290205C1 (ru) * 2005-09-13 2006-12-27 Федеральное государственное унитарное предприятие "Научно-производственное объединение по медицинским иммунологическим препаратам "МИКРОГЕН" Министерства здравоохранения Российской Федерации Способ получения живой вакцины для профилактики гриппа

Also Published As

Publication number Publication date
CN101631563A (zh) 2010-01-20
AU2008225501B2 (en) 2013-08-29
MX2009009635A (es) 2009-09-22
CN101631563B (zh) 2013-07-24
AR065640A1 (es) 2009-06-17
RU2484847C2 (ru) 2013-06-20
BRPI0808037A2 (pt) 2014-06-17
MY149924A (en) 2013-10-31
IL200588A0 (en) 2010-05-17
AU2008225501A1 (en) 2008-09-18
HK1139076A1 (en) 2010-09-10
EP2119451A1 (en) 2009-11-18
JPWO2008111532A1 (ja) 2010-06-24
WO2008111532A1 (ja) 2008-09-18
CA2680193C (en) 2015-05-05
CA2680193A1 (en) 2008-09-18
RU2009137380A (ru) 2011-04-20
JP5388842B2 (ja) 2014-01-15
AU2008225501A2 (en) 2009-09-24
US8216588B2 (en) 2012-07-10
KR20090128463A (ko) 2009-12-15
TW200848074A (en) 2008-12-16
EP2119451A4 (en) 2012-05-16
ZA200905952B (en) 2010-11-24
TWI428140B (zh) 2014-03-01
SG179406A1 (en) 2012-04-27
US20100104595A1 (en) 2010-04-29
NZ579395A (en) 2012-05-25

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