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)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Virology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Mycology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Wood Science & Technology (AREA)
  • Pulmonology (AREA)
  • Zoology (AREA)
  • Genetics & Genomics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biochemistry (AREA)
  • Dermatology (AREA)
  • Molecular Biology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (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 (20)

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)
HK (1) HK1139076A1 (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
JP6417217B2 (ja) * 2011-06-28 2018-10-31 ロイコケア・アクチェンゲゼルシャフト ウイルスまたは細菌の新規な安定化方法
PT2948129T (pt) * 2013-01-25 2018-02-12 Wintermute Biomedical Inc Compostos terapêuticos
GB201314248D0 (en) * 2013-08-08 2013-09-25 Glaxosmithkline Biolog Sa Saccharide vaccine formulation
EP3041504B1 (en) * 2013-09-03 2021-08-25 Georgia Tech Research Corporation Thermally stable vaccine formulations and microneedles
CN105636609A (zh) * 2013-10-25 2016-06-01 白血球保健股份有限公司 一种新颖的生产稳定疫苗的方法
EP3381468A4 (en) * 2015-11-27 2019-06-05 Nitto Denko Corporation DRIED INFLUENZA VACCINE PREPARATION AND METHOD FOR PRODUCING A DRIED INFLUENZED VACCINE PREPARATION
TW201722472A (zh) 2015-11-27 2017-07-01 Nitto Denko Corp 口腔內投與用疫苗醫藥組合物及口腔內投與用疫苗醫藥組合物之製造方法
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
EP3579855A4 (en) 2017-02-13 2020-12-16 Wintermute Biomedical, Inc. ANTI-PATHOGENIC THERAPEUTIC COMPOSITIONS
US20220000825A1 (en) 2018-10-01 2022-01-06 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
US7282219B2 (en) * 2000-03-31 2007-10-16 Kirin Beer Kabushiki Kaisha Powdery preparation for transmucosal administration containing a polymeric form of drug and exhibiting improved storage stability
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
EP2769735B1 (en) * 2004-10-06 2017-04-19 MedImmune, LLC Refrigerator-temperature stable influenza vaccine compositions
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
AR065640A1 (es) 2009-06-17
AU2008225501A1 (en) 2008-09-18
CA2680193C (en) 2015-05-05
KR20090128463A (ko) 2009-12-15
MY149924A (en) 2013-10-31
US20100104595A1 (en) 2010-04-29
US8216588B2 (en) 2012-07-10
EP2119451A1 (en) 2009-11-18
CN101631563A (zh) 2010-01-20
ZA200905952B (en) 2010-11-24
AU2008225501B2 (en) 2013-08-29
TWI428140B (zh) 2014-03-01
TW200848074A (en) 2008-12-16
JP5388842B2 (ja) 2014-01-15
AU2008225501A2 (en) 2009-09-24
SG179406A1 (en) 2012-04-27
RU2484847C2 (ru) 2013-06-20
WO2008111532A1 (ja) 2008-09-18
NZ579395A (en) 2012-05-25
CA2680193A1 (en) 2008-09-18
CN101631563B (zh) 2013-07-24
RU2009137380A (ru) 2011-04-20
MX2009009635A (es) 2009-09-22
HK1139076A1 (en) 2010-09-10
JPWO2008111532A1 (ja) 2010-06-24
BRPI0808037A2 (pt) 2014-06-17
EP2119451A4 (en) 2012-05-16
IL200588A0 (en) 2010-05-17

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