HRP20180054T1 - Farmaceutski pripravci koji sadrže toksoide clostridium difficile a i b - Google Patents
Farmaceutski pripravci koji sadrže toksoide clostridium difficile a i b Download PDFInfo
- Publication number
- HRP20180054T1 HRP20180054T1 HRP20180054TT HRP20180054T HRP20180054T1 HR P20180054 T1 HRP20180054 T1 HR P20180054T1 HR P20180054T T HRP20180054T T HR P20180054TT HR P20180054 T HRP20180054 T HR P20180054T HR P20180054 T1 HRP20180054 T1 HR P20180054T1
- Authority
- HR
- Croatia
- Prior art keywords
- preparation
- sodium
- clostridium difficile
- toxoid
- sucrose
- Prior art date
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
- A61K39/02—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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (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)
- 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)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US97249607P | 2007-09-14 | 2007-09-14 | |
| PCT/US2008/010767 WO2009035707A1 (en) | 2007-09-14 | 2008-09-15 | Pharmaceutical compositions containing clostridium difficile toxoids a and b |
| EP08830210.4A EP2198007B1 (en) | 2007-09-14 | 2008-09-15 | Pharmaceutical compositions containing clostridium difficile toxoids a and b |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20180054T1 true HRP20180054T1 (hr) | 2018-02-09 |
Family
ID=40452372
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20180054TT HRP20180054T1 (hr) | 2007-09-14 | 2008-09-15 | Farmaceutski pripravci koji sadrže toksoide clostridium difficile a i b |
Country Status (21)
Families Citing this family (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| HRP20180054T1 (hr) | 2007-09-14 | 2018-02-09 | Sanofi Pasteur Biologics, Llc | Farmaceutski pripravci koji sadrže toksoide clostridium difficile a i b |
| DK2753352T4 (da) | 2010-09-03 | 2022-09-12 | Valneva Austria Gmbh | Isoleret polypeptid af toxin a og toxin b proteinerne fra c. difficile og anvendelser deraf |
| GB201105981D0 (en) * | 2011-04-08 | 2011-05-18 | Glaxosmithkline Biolog Sa | Novel process |
| ES2968629T3 (es) * | 2011-04-22 | 2024-05-13 | Wyeth Llc | Composiciones relacionadas con una toxina mutante de Clostridium difficile y sus procedimientos |
| 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 |
| KR102149206B1 (ko) | 2012-11-08 | 2020-08-31 | 세센 바이오, 아이엔씨. | 인터루킨-6의 길항제 및 이의 용도 |
| HRP20190711T1 (hr) | 2012-12-05 | 2019-05-31 | Glaxosmithkline Biologicals S.A. | Imunogeni pripravak |
| CN111729077A (zh) | 2013-03-14 | 2020-10-02 | 武田疫苗股份有限公司 | 减毒活甲病毒制剂的组合物和方法 |
| CA2907156A1 (en) * | 2013-03-15 | 2014-09-18 | Sanofi Pasteur, Inc. | Toxins, compositions and related methods |
| BR112015023332A2 (pt) * | 2013-03-15 | 2017-08-22 | Sanofi Pasteur Inc | Toxóide, composições e método relacionados |
| EP3007724B1 (en) * | 2013-06-14 | 2023-07-05 | Sanofi Pasteur Inc. | Compositions and methods of immunizing against c. difficile |
| BR112015031541A2 (pt) * | 2013-06-17 | 2017-07-25 | De Staat Der Nederlanden Vert Door De Mini Van Vws Miniie Van Volksgezondheid Welzijn En Sport | métodos para o impedimento da agregação de componentes virais |
| US9930893B2 (en) * | 2014-02-10 | 2018-04-03 | The Johns Hopkins University | Inhibitors of DXP synthase and methods of use thereof |
| UA122673C2 (uk) | 2014-11-07 | 2020-12-28 | Елевен Байотерапьютікс, Інк. | Антитіло, що специфічно зв'язується з людським il-6 |
| US20180110849A1 (en) | 2015-05-15 | 2018-04-26 | Sanofi Pasteur, Inc. | Methods for immunizing against clostridium difficile |
| BE1023343B1 (nl) * | 2015-05-20 | 2017-02-09 | Mycartis Nv | Opslagbuffer |
| KR20180116359A (ko) | 2016-02-23 | 2018-10-24 | 세센 바이오, 아이엔씨. | 인터루킨-6의 길항제 제제 및 이의 용도 |
| PL3432916T3 (pl) | 2016-09-13 | 2020-04-30 | Allergan, Inc. | Niebiałkowo stabilzowane kompozycje toksyny clostridium |
| ES2986389T3 (es) * | 2018-05-21 | 2024-11-11 | Chugai Pharmaceutical Co Ltd | Formulación liofilizada sellada en un vial de vidrio |
| EP4168032A2 (en) * | 2020-06-19 | 2023-04-26 | Pfizer Inc. | Immunogenic compositions against clostridioides (clostridium) difficile and methods thereof |
Family Cites Families (35)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4879218A (en) * | 1982-09-13 | 1989-11-07 | Virginia Tech Intellectual Properties, Inc. | Antibody for C.difficile |
| US5736139A (en) * | 1989-10-31 | 1998-04-07 | Ochidian Pharmaceuticals, Inc. | Treatment of Clostridium difficile induced disease |
| JPH03193735A (ja) | 1989-12-22 | 1991-08-23 | Shionogi & Co Ltd | グリコペプチド系抗生物質の安定化組成物 |
| ES2104845T3 (es) * | 1991-10-16 | 1997-10-16 | Schering Corp | Composiciones lipofilas de sales de antibioticos oligosacaridos. |
| AU4646393A (en) | 1992-06-23 | 1994-01-24 | Interactive Biologics Associates | Pharmaceutical composition containing botulinum b complex |
| US5562909A (en) | 1993-07-12 | 1996-10-08 | Massachusetts Institute Of Technology | Phosphazene polyelectrolytes as immunoadjuvants |
| US5902565A (en) * | 1993-12-24 | 1999-05-11 | Csl Limited | Spray dried vaccine preparation comprising aluminium adsorbed immunogens |
| US5512547A (en) * | 1994-10-13 | 1996-04-30 | Wisconsin Alumni Research Foundation | Pharmaceutical composition of botulinum neurotoxin and method of preparation |
| JPH08333277A (ja) | 1995-06-05 | 1996-12-17 | Hoechst Japan Ltd | ヒト血液凝固第ｘｉｉｉ因子の安定化された水性液製剤 |
| CN1195993A (zh) * | 1995-07-07 | 1998-10-14 | 奥拉瓦克斯有限公司 | 抗胃肠疾病的鼻内接种 |
| US5932223A (en) | 1996-09-26 | 1999-08-03 | Merck & Co., Inc. | Rotavirus vaccine formulations |
| EP0892054B1 (en) * | 1997-06-20 | 2006-11-29 | Intervet International BV | Clostridium perfringens vaccine |
| DE69829400T2 (de) * | 1997-10-20 | 2006-04-13 | Acambis, Inc., Cambridge | Passive immunisierung gegen durch clostridium difficile verursachte krankheit |
| US6969520B2 (en) * | 1997-10-20 | 2005-11-29 | Acambis Inc. | Active immunization against clostridium difficile disease |
| EP1568378B1 (en) * | 1997-10-20 | 2016-03-16 | Sanofi Pasteur Biologics, LLC | Immunization against Clostridium difficile disease |
| US6013635A (en) * | 1998-05-28 | 2000-01-11 | Synsorb Biotech, Inc. | Treatment of C. difficile toxin B associated conditions |
| JP2000117967A (ja) * | 1998-10-16 | 2000-04-25 | Fuji Photo Film Co Ltd | インクジェット記録方法 |
| FR2791895B1 (fr) | 1999-03-23 | 2001-06-15 | Pasteur Merieux Serums Vacc | Utilisation de trehalose pour stabiliser un vaccin liquide |
| DK1187629T3 (da) * | 1999-04-19 | 2005-01-17 | Glaxosmithkline Biolog Sa | Adjuvanssammensætning omfattende saponin og et immunostimulerende oligonucleotid |
| US6599715B1 (en) * | 1999-05-12 | 2003-07-29 | The Regents Of The University Of California | Real time viability detection of bacterial spores |
| US7780967B2 (en) * | 2000-02-08 | 2010-08-24 | Allergan, Inc. | Reduced toxicity Clostridial toxin pharmaceutical compositions |
| EP3192528A1 (en) | 2002-02-14 | 2017-07-19 | Chugai Seiyaku Kabushiki Kaisha | Formulation of anti-il6r antibody-containing solutions comprising a sugar as a stabilizer |
| WO2003088946A1 (en) * | 2002-04-19 | 2003-10-30 | The Regents Of The University Of Michigan | Polymer compositions that stabilize and control the release of formaldehyde-treated vaccine antigens |
| US20040235139A1 (en) * | 2002-12-23 | 2004-11-25 | Demain Arnold L. | Clostridium difficile culture and toxin production methods |
| DE10333317A1 (de) * | 2003-07-22 | 2005-02-17 | Biotecon Therapeutics Gmbh | Formulierung für Proteinarzneimittel ohne Zusatz von humanem Serumalbumin (HSA) |
| WO2005035573A1 (ja) | 2003-10-09 | 2005-04-21 | Chugai Seiyaku Kabushiki Kaisha | タンパク質溶液の安定化方法 |
| CN102139099A (zh) * | 2004-07-26 | 2011-08-03 | 莫茨药物股份两合公司 | 包含肉毒杆菌神经毒素的治疗组合物 |
| JP2008515996A (ja) * | 2004-10-13 | 2008-05-15 | イリプサ， インコーポレイテッド | 毒素結合性オリゴ糖および重合体粒子を含有する医薬組成物 |
| FR2881139A1 (fr) * | 2005-01-26 | 2006-07-28 | Agronomique Inst Nat Rech | Composition pour la lyophilisation de proteines |
| US8137677B2 (en) | 2005-10-06 | 2012-03-20 | Allergan, Inc. | Non-protein stabilized clostridial toxin pharmaceutical compositions |
| BRPI0613001B8 (pt) | 2005-10-06 | 2021-05-25 | Allergan Inc | composições farmacêuticas de toxina clostrídica estabilizada por uma não-proteína |
| WO2007044809A2 (en) * | 2005-10-11 | 2007-04-19 | Botulinum Toxin Research Associates, Inc. | Albumin-free botulinum toxin based pharmaceutical compositions containing a hyaluronidase and methods of use |
| EP2086581B1 (en) | 2006-11-07 | 2014-08-13 | Sanofi Pasteur Biologics, LLC | Stabilization of vaccines by lyophilization |
| HRP20180054T1 (hr) | 2007-09-14 | 2018-02-09 | Sanofi Pasteur Biologics, Llc | Farmaceutski pripravci koji sadrže toksoide clostridium difficile a i b |
| JP2012510497A (ja) * | 2008-12-03 | 2012-05-10 | ベーリンガー インゲルハイム フェトメディカ ゲゼルシャフト ミット ベシュレンクテル ハフツング | ワクチンの生産方法 |
-
2008
- 2008-09-15 HR HRP20180054TT patent/HRP20180054T1/hr unknown
- 2008-09-15 EP EP24220340.4A patent/EP4537849A3/en active Pending
- 2008-09-15 ES ES16174817T patent/ES3001561T3/es active Active
- 2008-09-15 CA CA2699435A patent/CA2699435A1/en not_active Abandoned
- 2008-09-15 PT PT88302104T patent/PT2198007T/pt unknown
- 2008-09-15 MX MX2010002815A patent/MX2010002815A/es unknown
- 2008-09-15 NO NO08830210A patent/NO2198007T3/no unknown
- 2008-09-15 RU RU2010114730/10A patent/RU2550271C2/ru not_active IP Right Cessation
- 2008-09-15 BR BRPI0816790A patent/BRPI0816790A8/pt not_active IP Right Cessation
- 2008-09-15 SI SI200831906T patent/SI2198007T1/en unknown
- 2008-09-15 EP EP08830210.4A patent/EP2198007B1/en not_active Not-in-force
- 2008-09-15 AU AU2008299885A patent/AU2008299885C1/en not_active Ceased
- 2008-09-15 DK DK08830210.4T patent/DK2198007T3/en active
- 2008-09-15 WO PCT/US2008/010767 patent/WO2009035707A1/en not_active Ceased
- 2008-09-15 EP EP16174817.3A patent/EP3124044B8/en active Active
- 2008-09-15 KR KR1020107007994A patent/KR101679812B1/ko not_active Expired - Fee Related
- 2008-09-15 PL PL08830210T patent/PL2198007T3/pl unknown
- 2008-09-15 CN CN200880116603.0A patent/CN101855336B/zh active Active
- 2008-09-15 ES ES08830210.4T patent/ES2657485T3/es active Active
- 2008-09-15 CN CN201610227574.1A patent/CN106039299A/zh active Pending
- 2008-09-15 KR KR1020157036693A patent/KR20160005378A/ko not_active Abandoned
- 2008-09-15 JP JP2010524889A patent/JP5503543B2/ja active Active
- 2008-09-15 US US12/677,864 patent/US9320790B2/en active Active
- 2008-09-15 HU HUE08830210A patent/HUE037932T2/hu unknown
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2010
- 2010-03-09 IL IL204366A patent/IL204366A/en active IP Right Grant
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2013
- 2013-11-22 JP JP2013241821A patent/JP6258674B2/ja active Active
-
2016
- 2016-03-29 US US15/083,428 patent/US9687541B2/en active Active
- 2016-10-31 JP JP2016212540A patent/JP2017052773A/ja active Pending
-
2017
- 2017-06-26 US US15/632,480 patent/US10639362B2/en active Active
-
2018
- 2018-01-23 CY CY20181100084T patent/CY1119979T1/el unknown
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