CN103282045A - 因子viii水溶液 - Google Patents

因子viii水溶液 Download PDF

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Publication number
CN103282045A
CN103282045A CN2011800584021A CN201180058402A CN103282045A CN 103282045 A CN103282045 A CN 103282045A CN 2011800584021 A CN2011800584021 A CN 2011800584021A CN 201180058402 A CN201180058402 A CN 201180058402A CN 103282045 A CN103282045 A CN 103282045A
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CN
China
Prior art keywords
fviii
concentration
solution
salt
aqueous solution
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.)
Withdrawn
Application number
CN2011800584021A
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English (en)
Chinese (zh)
Inventor
克里斯蒂安·里舍尔
C.杰斯佩加尔德
A.博格斯内斯
J.克拉鲁普
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Novo Nordisk AS
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Novo Nordisk AS
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Publication date
Application filed by Novo Nordisk AS filed Critical Novo Nordisk AS
Publication of CN103282045A publication Critical patent/CN103282045A/zh
Withdrawn legal-status Critical Current

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    • 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
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36Blood coagulation or fibrinolysis factors
    • A61K38/37Factors VIII
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • 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
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745Blood coagulation or fibrinolysis factors
    • C07K14/755Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Hematology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Toxicology (AREA)
  • Immunology (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
CN2011800584021A 2010-12-16 2011-11-30 因子viii水溶液 Withdrawn CN103282045A (zh)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
EP10195288 2010-12-16
EP10195288.5 2010-12-16
US201061424389P 2010-12-17 2010-12-17
US61/424389 2010-12-17
PCT/EP2011/071339 WO2012079979A1 (en) 2010-12-16 2011-11-30 Aqueous factor viii solution

Publications (1)

Publication Number Publication Date
CN103282045A true CN103282045A (zh) 2013-09-04

Family

ID=43798550

Family Applications (1)

Application Number Title Priority Date Filing Date
CN2011800584021A Withdrawn CN103282045A (zh) 2010-12-16 2011-11-30 因子viii水溶液

Country Status (8)

Country Link
US (1) US20130345403A1 (https=)
EP (1) EP2651433A1 (https=)
JP (1) JP2014501227A (https=)
KR (1) KR20130125789A (https=)
CN (1) CN103282045A (https=)
CA (1) CA2821945A1 (https=)
RU (1) RU2013131911A (https=)
WO (1) WO2012079979A1 (https=)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105705516A (zh) * 2013-11-08 2016-06-22 杰特有限公司 浓缩von Willebrand因子或其络合物的新方法

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11299533B2 (en) * 2017-06-23 2022-04-12 Takeda Pharmaceutical Company Limited Purification of factor VIII subspecies

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5605884A (en) * 1987-10-29 1997-02-25 Rhone-Poulenc Rorer Pharmaceuticals Inc. Factor VIII formulations in high ionic strength media
EP1016673A1 (en) * 1992-10-02 2000-07-05 Genetics Institute, Inc. Composition comprising coagulation factor VIII formulation, process for its preparation and use of a surfactant as stabilizer
WO2000048635A1 (en) * 1999-02-22 2000-08-24 Baxter International Inc. Novel albumin-free factor viii formulations
WO2009108806A1 (en) * 2008-02-27 2009-09-03 Novo Nordisk A/S Conjugated factor viii molecules

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4795806A (en) * 1987-07-16 1989-01-03 Miles Laboratories, Inc. Phospholipid affinity purification of Factor VIII:C
CA1329760C (en) * 1987-10-29 1994-05-24 Ted C. K. Lee Plasma and recombinant protein formulations in high ionic strength media
SE9503380D0 (sv) * 1995-09-29 1995-09-29 Pharmacia Ab Protein derivatives
AUPR638801A0 (en) * 2001-07-13 2001-08-09 Life Therapeutics Limited Factor viii separation
ES2411007T3 (es) 2001-10-10 2013-07-04 Novo Nordisk A/S Remodelación y glicoconjugación de péptidos
CN1917861B (zh) * 2003-12-19 2012-03-21 诺和诺德医疗保健公司 因子vii多肽的稳定化固体组合物
PT2363414T (pt) * 2004-11-12 2022-08-04 Bayer Healthcare Llc Modificação de fviii direcionada a sítio
EP1871801A2 (en) * 2005-04-01 2008-01-02 Novo Nordisk Health Care AG Blood coagulation fviii analogues
AU2007245190B2 (en) * 2006-03-31 2011-07-21 Takeda Pharmaceutical Company Limited Pegylated factor VIII
ES2401965T3 (es) * 2009-02-19 2013-04-25 Novo Nordisk A/S Modificación de Factor VIII

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5605884A (en) * 1987-10-29 1997-02-25 Rhone-Poulenc Rorer Pharmaceuticals Inc. Factor VIII formulations in high ionic strength media
EP1016673A1 (en) * 1992-10-02 2000-07-05 Genetics Institute, Inc. Composition comprising coagulation factor VIII formulation, process for its preparation and use of a surfactant as stabilizer
WO2000048635A1 (en) * 1999-02-22 2000-08-24 Baxter International Inc. Novel albumin-free factor viii formulations
WO2009108806A1 (en) * 2008-02-27 2009-09-03 Novo Nordisk A/S Conjugated factor viii molecules

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
GOULIAN M等: "Stabilization of factor 8 by glycerol", 《NATURE》 *
SAENKO E等: "Strategies towards a longer acting factor VIII", 《HAEMOPHILIA》 *
陈玉昆等: "《天然药物提取及生产工艺》", 31 December 2005, 科学出版社 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105705516A (zh) * 2013-11-08 2016-06-22 杰特有限公司 浓缩von Willebrand因子或其络合物的新方法
CN105705516B (zh) * 2013-11-08 2019-11-01 杰特有限公司 浓缩von Willebrand因子或其络合物的方法

Also Published As

Publication number Publication date
RU2013131911A (ru) 2015-01-27
US20130345403A1 (en) 2013-12-26
EP2651433A1 (en) 2013-10-23
CA2821945A1 (en) 2012-06-21
JP2014501227A (ja) 2014-01-20
WO2012079979A1 (en) 2012-06-21
KR20130125789A (ko) 2013-11-19

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C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
C04 Withdrawal of patent application after publication (patent law 2001)
WW01 Invention patent application withdrawn after publication

Application publication date: 20130904