JP5503543B2 - クロストリジウム・ディフィシレトキソイドａおよびｂを含有する薬学的組成物 - Google Patents

クロストリジウム・ディフィシレトキソイドａおよびｂを含有する薬学的組成物 Download PDF

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JP5503543B2
JP5503543B2 JP2010524889A JP2010524889A JP5503543B2 JP 5503543 B2 JP5503543 B2 JP 5503543B2 JP 2010524889 A JP2010524889 A JP 2010524889A JP 2010524889 A JP2010524889 A JP 2010524889A JP 5503543 B2 JP5503543 B2 JP 5503543B2
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toxoid
composition
excipients
sucrose
aggregation
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シー． ラッセル ミドー
リチャード ファーナー
ピーター シアラメタロ
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サノフィ パスツール バイオロジクス リミテッド ライアビリティ カンパニー
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    • 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
    • A61K39/02—Bacterial antigens
    • A61K39/08—Clostridium, e.g. Clostridium tetani
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • 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
    • 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
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/12—Antidiarrhoeals
    • 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
    • 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
    • A61P31/04—Antibacterial agents
    • 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
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
    • 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
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55505—Inorganic adjuvants
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Biochemistry (AREA)
  • Dermatology (AREA)
  • Molecular Biology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Biotechnology (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Virology (AREA)
  • Biomedical Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
JP2010524889A 2007-09-14 2008-09-15 クロストリジウム・ディフィシレトキソイドａおよびｂを含有する薬学的組成物 Active JP5503543B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US97249607P 2007-09-14 2007-09-14
US60/972,496 2007-09-14
PCT/US2008/010767 WO2009035707A1 (en) 2007-09-14 2008-09-15 Pharmaceutical compositions containing clostridium difficile toxoids a and b

Related Child Applications (1)

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JP2013241821A Division JP6258674B2 (ja) 2007-09-14 2013-11-22 クロストリジウム・ディフィシレトキソイドａおよびｂを含有する薬学的組成物

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JP2010539172A JP2010539172A (ja) 2010-12-16
JP2010539172A5 JP2010539172A5 (https=) 2011-04-21
JP5503543B2 true JP5503543B2 (ja) 2014-05-28

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JP2010524889A Active JP5503543B2 (ja) 2007-09-14 2008-09-15 クロストリジウム・ディフィシレトキソイドａおよびｂを含有する薬学的組成物
JP2013241821A Active JP6258674B2 (ja) 2007-09-14 2013-11-22 クロストリジウム・ディフィシレトキソイドａおよびｂを含有する薬学的組成物
JP2016212540A Pending JP2017052773A (ja) 2007-09-14 2016-10-31 クロストリジウム・ディフィシレトキソイドａおよびｂを含有する薬学的組成物

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JP2016212540A Pending JP2017052773A (ja) 2007-09-14 2016-10-31 クロストリジウム・ディフィシレトキソイドａおよびｂを含有する薬学的組成物

Country Status (21)

Country Link
US (3) US9320790B2 (https=)
EP (3) EP3124044B8 (https=)
JP (3) JP5503543B2 (https=)
KR (2) KR20160005378A (https=)
CN (2) CN106039299A (https=)
AU (1) AU2008299885C1 (https=)
BR (1) BRPI0816790A8 (https=)
CA (1) CA2699435A1 (https=)
CY (1) CY1119979T1 (https=)
DK (1) DK2198007T3 (https=)
ES (2) ES2657485T3 (https=)
HR (1) HRP20180054T1 (https=)
HU (1) HUE037932T2 (https=)
IL (1) IL204366A (https=)
MX (1) MX2010002815A (https=)
NO (1) NO2198007T3 (https=)
PL (1) PL2198007T3 (https=)
PT (1) PT2198007T (https=)
RU (1) RU2550271C2 (https=)
SI (1) SI2198007T1 (https=)
WO (1) WO2009035707A1 (https=)

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MX2010002815A (es) 2010-07-30
CN101855336A (zh) 2010-10-06
NO2198007T3 (https=) 2018-03-24
RU2010114730A (ru) 2011-10-20
EP4537849A3 (en) 2025-07-09
US20160317640A1 (en) 2016-11-03
AU2008299885A1 (en) 2009-03-19
HRP20180054T1 (hr) 2018-02-09
JP2014055174A (ja) 2014-03-27
EP3124044B8 (en) 2025-01-22
CN101855336B (zh) 2019-07-30
KR101679812B1 (ko) 2016-11-28
EP2198007A4 (en) 2012-03-07
CN106039299A (zh) 2016-10-26
JP6258674B2 (ja) 2018-01-10
AU2008299885C1 (en) 2015-06-25
EP3124044C0 (en) 2024-12-18
US9687541B2 (en) 2017-06-27
WO2009035707A9 (en) 2010-06-10
IL204366A (en) 2013-02-28
US20110045025A1 (en) 2011-02-24
ES3001561T3 (en) 2025-03-05
EP2198007B1 (en) 2017-10-25
EP2198007A1 (en) 2010-06-23
JP2010539172A (ja) 2010-12-16
PT2198007T (pt) 2018-01-29
AU2008299885B2 (en) 2014-12-11
EP3124044B1 (en) 2024-12-18
BRPI0816790A2 (pt) 2014-10-14
KR20100075912A (ko) 2010-07-05
US9320790B2 (en) 2016-04-26
CA2699435A1 (en) 2009-03-19
WO2009035707A1 (en) 2009-03-19
PL2198007T3 (pl) 2018-03-30
DK2198007T3 (en) 2018-01-15
US20180000920A1 (en) 2018-01-04
US10639362B2 (en) 2020-05-05
HUE037932T2 (hu) 2018-09-28
JP2017052773A (ja) 2017-03-16
BRPI0816790A8 (pt) 2017-05-16
SI2198007T1 (en) 2018-04-30
EP4537849A2 (en) 2025-04-16
EP3124044A1 (en) 2017-02-01
CY1119979T1 (el) 2018-12-12
RU2550271C2 (ru) 2015-05-10
KR20160005378A (ko) 2016-01-14
ES2657485T3 (es) 2018-03-05

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