ES3001561T3 - Pharmaceutical compositions containing clostridium difficile toxoids a and b - Google Patents

Pharmaceutical compositions containing clostridium difficile toxoids a and b Download PDF

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Publication number
ES3001561T3
ES3001561T3 ES16174817T ES16174817T ES3001561T3 ES 3001561 T3 ES3001561 T3 ES 3001561T3 ES 16174817 T ES16174817 T ES 16174817T ES 16174817 T ES16174817 T ES 16174817T ES 3001561 T3 ES3001561 T3 ES 3001561T3
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ES
Spain
Prior art keywords
toxoid
toxoids
aggregation
excipients
tween
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
ES16174817T
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English (en)
Spanish (es)
Inventor
Russell C Middaugh
Richard Fahrner
Peter Ciarametaro
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sanofi Pasteur Inc
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Sanofi Pasteur Inc
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 Sanofi Pasteur Inc filed Critical Sanofi Pasteur Inc
Application granted granted Critical
Publication of ES3001561T3 publication Critical patent/ES3001561T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/08Clostridium, e.g. Clostridium tetani
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/14Particulate 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/12Antidiarrhoeals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/04Immunostimulants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55505Inorganic adjuvants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (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)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (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)
ES16174817T 2007-09-14 2008-09-15 Pharmaceutical compositions containing clostridium difficile toxoids a and b Active ES3001561T3 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US97249607P 2007-09-14 2007-09-14

Publications (1)

Publication Number Publication Date
ES3001561T3 true ES3001561T3 (en) 2025-03-05

Family

ID=40452372

Family Applications (2)

Application Number Title Priority Date Filing Date
ES16174817T Active ES3001561T3 (en) 2007-09-14 2008-09-15 Pharmaceutical compositions containing clostridium difficile toxoids a and b
ES08830210.4T Active ES2657485T3 (es) 2007-09-14 2008-09-15 Composiciones farmacéuticas que contienen toxoides A y B de Clostridium difficile

Family Applications After (1)

Application Number Title Priority Date Filing Date
ES08830210.4T Active ES2657485T3 (es) 2007-09-14 2008-09-15 Composiciones farmacéuticas que contienen toxoides A y B de Clostridium difficile

Country Status (21)

Country Link
US (3) US9320790B2 (enExample)
EP (3) EP3124044B8 (enExample)
JP (3) JP5503543B2 (enExample)
KR (2) KR20160005378A (enExample)
CN (2) CN101855336B (enExample)
AU (1) AU2008299885C1 (enExample)
BR (1) BRPI0816790A8 (enExample)
CA (1) CA2699435A1 (enExample)
CY (1) CY1119979T1 (enExample)
DK (1) DK2198007T3 (enExample)
ES (2) ES3001561T3 (enExample)
HR (1) HRP20180054T1 (enExample)
HU (1) HUE037932T2 (enExample)
IL (1) IL204366A (enExample)
MX (1) MX2010002815A (enExample)
NO (1) NO2198007T3 (enExample)
PL (1) PL2198007T3 (enExample)
PT (1) PT2198007T (enExample)
RU (1) RU2550271C2 (enExample)
SI (1) SI2198007T1 (enExample)
WO (1) WO2009035707A1 (enExample)

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CN101855336B (zh) 2007-09-14 2019-07-30 赛诺菲巴斯德生物制剂有限责任公司 含艰难梭菌类毒素a和b的药物组合物
CN103957931B (zh) 2010-09-03 2017-10-24 瓦尔内瓦奥地利有限责任公司 艰难梭状芽胞杆菌毒素a和毒素b蛋白的分离多肽及其用途
GB201105981D0 (en) * 2011-04-08 2011-05-18 Glaxosmithkline Biolog Sa Novel process
TWI815599B (zh) 2011-04-22 2023-09-11 美商惠氏有限責任公司 與難養芽胞梭菌(Clostridium difficile)之突變毒素有關之組成物及彼之方法
KR101135486B1 (ko) * 2011-05-25 2012-04-13 함종욱 보툴리눔 에이형 독소의 액상제품
BR122016023101B1 (pt) 2012-10-21 2022-03-22 Pfizer Inc Polipeptídeo, composição imunogênica que o compreende, bem como célula recombinante derivada de clostridium difficile
CN104903349B (zh) 2012-11-08 2018-10-19 十一生物治疗股份有限公司 Il-6拮抗剂及其应用
WO2014086787A1 (en) 2012-12-05 2014-06-12 Glaxosmithkline Biologicals S.A. Immunogenic composition
MX361342B (es) 2013-03-14 2018-12-04 Takeda Vaccines Inc Composiciones y metodos para formulaciones de alfavirus vivos atenuados.
AU2014228983B2 (en) 2013-03-15 2018-04-05 Sanofi Pasteur, Inc. Toxoid, compositions and related methods
WO2014144567A2 (en) * 2013-03-15 2014-09-18 Sanofi Pasteur, Inc. Toxoid, compositions and related methods
CN105611942A (zh) * 2013-06-14 2016-05-25 圣诺菲·帕斯图尔公司 针对艰难梭菌免疫的组合物和方法
PL3010537T3 (pl) * 2013-06-17 2019-03-29 De Staat Der Nederlanden, Vert. Door De Minister Van Vws, Ministerie Van Volksgezondheid, Welzijn En Sport Sposoby zapobiegania agregacji komponentów wirusowych
US9930893B2 (en) * 2014-02-10 2018-04-03 The Johns Hopkins University Inhibitors of DXP synthase and methods of use thereof
DK4268843T3 (da) 2014-11-07 2025-11-10 F Hoffmann La Roche Ltd Forbedrede IL-6-antistoffer
EP3294330A1 (en) 2015-05-15 2018-03-21 Sanofi Pasteur, Inc. Methods for immunizing against clostridium difficile
BE1023343B1 (nl) * 2015-05-20 2017-02-09 Mycartis Nv Opslagbuffer
WO2017147293A1 (en) 2016-02-23 2017-08-31 Eleven Biotherapeutics, Inc. Il-6 antagonist formulations and uses thereof
HUE046449T2 (hu) 2016-09-13 2020-03-30 Allergan Inc Stabilizált, nem fehérje eredetû, clostridiális toxin készítmények
WO2019225568A1 (ja) * 2018-05-21 2019-11-28 中外製薬株式会社 ガラス容器に封入された凍結乾燥製剤
WO2021255690A2 (en) * 2020-06-19 2021-12-23 Pfizer Inc. Immunogenic compositions against clostridioides (clostridium) difficile and methods thereof

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KR20110100189A (ko) * 2008-12-03 2011-09-09 베링거잉겔하임베트메디카게엠베하 백신 생산 방법

Also Published As

Publication number Publication date
CN101855336B (zh) 2019-07-30
RU2010114730A (ru) 2011-10-20
BRPI0816790A2 (pt) 2014-10-14
EP2198007A1 (en) 2010-06-23
CY1119979T1 (el) 2018-12-12
AU2008299885B2 (en) 2014-12-11
CA2699435A1 (en) 2009-03-19
EP3124044B1 (en) 2024-12-18
EP3124044C0 (en) 2024-12-18
AU2008299885A1 (en) 2009-03-19
DK2198007T3 (en) 2018-01-15
US20180000920A1 (en) 2018-01-04
EP4537849A2 (en) 2025-04-16
EP2198007B1 (en) 2017-10-25
JP2010539172A (ja) 2010-12-16
JP6258674B2 (ja) 2018-01-10
EP4537849A3 (en) 2025-07-09
KR101679812B1 (ko) 2016-11-28
WO2009035707A1 (en) 2009-03-19
JP2014055174A (ja) 2014-03-27
US20110045025A1 (en) 2011-02-24
PL2198007T3 (pl) 2018-03-30
CN101855336A (zh) 2010-10-06
US10639362B2 (en) 2020-05-05
ES2657485T3 (es) 2018-03-05
KR20100075912A (ko) 2010-07-05
US9320790B2 (en) 2016-04-26
BRPI0816790A8 (pt) 2017-05-16
NO2198007T3 (enExample) 2018-03-24
WO2009035707A9 (en) 2010-06-10
IL204366A (en) 2013-02-28
PT2198007T (pt) 2018-01-29
MX2010002815A (es) 2010-07-30
JP5503543B2 (ja) 2014-05-28
KR20160005378A (ko) 2016-01-14
EP3124044B8 (en) 2025-01-22
HUE037932T2 (hu) 2018-09-28
EP3124044A1 (en) 2017-02-01
JP2017052773A (ja) 2017-03-16
CN106039299A (zh) 2016-10-26
AU2008299885C1 (en) 2015-06-25
HRP20180054T1 (hr) 2018-02-09
US20160317640A1 (en) 2016-11-03
US9687541B2 (en) 2017-06-27
RU2550271C2 (ru) 2015-05-10
SI2198007T1 (en) 2018-04-30
EP2198007A4 (en) 2012-03-07

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