DK1029548T3 - Fremgangsmåde til opretholdelse af kvaliteten af vandige, parenterale oplösninger af thrombomodulin under lagring og transport - Google Patents

Fremgangsmåde til opretholdelse af kvaliteten af vandige, parenterale oplösninger af thrombomodulin under lagring og transport

Info

Publication number
DK1029548T3
DK1029548T3 DK98947842T DK98947842T DK1029548T3 DK 1029548 T3 DK1029548 T3 DK 1029548T3 DK 98947842 T DK98947842 T DK 98947842T DK 98947842 T DK98947842 T DK 98947842T DK 1029548 T3 DK1029548 T3 DK 1029548T3
Authority
DK
Denmark
Prior art keywords
thrombomodulin
aqueous
solution
quality
aqueous parenteral
Prior art date
Application number
DK98947842T
Other languages
Danish (da)
English (en)
Inventor
Masaki Yui
Akira Yokozawa
Tomoyo Murata
Kazuhisa Tsuruta
Hirotomo Shimizu
Original Assignee
Asahi Kasei Pharma Corp
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=26554271&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK1029548(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Asahi Kasei Pharma Corp filed Critical Asahi Kasei Pharma Corp
Application granted granted Critical
Publication of DK1029548T3 publication Critical patent/DK1029548T3/da

Links

Classifications

    • 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
    • A61K38/55Protease inhibitors
    • A61K38/57Protease inhibitors from animals; from humans
    • 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
    • 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
    • A61K47/12Carboxylic 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
    • A61K47/26Carbohydrates, 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
    • A61K47/44Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • 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
    • C07K14/7455Thrombomodulin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides

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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Hematology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Genetics & Genomics (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Toxicology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Cardiology (AREA)
  • Diabetes (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Immunology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Peptides Or Proteins (AREA)
DK98947842T 1997-10-15 1998-10-13 Fremgangsmåde til opretholdelse af kvaliteten af vandige, parenterale oplösninger af thrombomodulin under lagring og transport DK1029548T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP28165997 1997-10-15
JP30852397 1997-11-11
PCT/JP1998/004609 WO1999018994A1 (en) 1997-10-15 1998-10-13 Method for keeping the quality of aqueous parenteral solution of thrombomodulin in storage and distribution

Publications (1)

Publication Number Publication Date
DK1029548T3 true DK1029548T3 (da) 2007-07-02

Family

ID=26554271

Family Applications (1)

Application Number Title Priority Date Filing Date
DK98947842T DK1029548T3 (da) 1997-10-15 1998-10-13 Fremgangsmåde til opretholdelse af kvaliteten af vandige, parenterale oplösninger af thrombomodulin under lagring og transport

Country Status (13)

Country Link
US (1) US6808706B1 (de)
EP (1) EP1029548B1 (de)
JP (1) JP4460762B2 (de)
KR (1) KR100373480B1 (de)
CN (1) CN1275916A (de)
AT (1) ATE358496T1 (de)
AU (1) AU729876B2 (de)
CA (1) CA2306206A1 (de)
DE (1) DE69837493T2 (de)
DK (1) DK1029548T3 (de)
ES (1) ES2281137T3 (de)
PT (1) PT1029548E (de)
WO (1) WO1999018994A1 (de)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2011025068A (ja) * 1999-02-22 2011-02-10 Chugai Pharmaceut Co Ltd プレフィルドシリンジタンパク質溶液製剤
JP2006346494A (ja) * 1999-02-22 2006-12-28 Chugai Pharmaceut Co Ltd プレフィルドシリンジタンパク質溶液製剤
US6585971B1 (en) * 1999-11-12 2003-07-01 Harbor-Ucla Research And Education Institute Recombinant α-L-iduronidase, methods for producing and purifying the same and methods for treating disease caused by deficiencies thereof
CA2394794C (en) * 1999-12-22 2009-08-25 Glaxo Group Limited Methods for preparing pharmaceutical formulations
DK1263936T3 (da) * 2000-03-14 2006-02-13 Bavarian Nordic As andret stamme af den modificerede Vacciniavirus Ankara (MVA)
EP1475098B1 (de) * 2002-01-18 2015-08-05 Asahi Kasei Pharma Corporation Hochkonzentrierte zubereitung von löslichem thrombomodulin
AU2007240732B2 (en) * 2006-04-21 2013-07-04 Amgen, Inc. Buffering agents for biopharmaceutical formulations
CA2681294C (en) * 2007-03-23 2014-05-06 Asahi Kasei Pharma Corporation Method for producing high-purity soluble thrombomodulin
AU2009210741A1 (en) * 2008-02-07 2009-08-13 Amgen Inc. Stabilized protein compositions
JP2011178687A (ja) * 2010-02-26 2011-09-15 Kochi Univ 造血細胞移植に伴う疼痛の予防および/または治療剤
US20120076779A1 (en) * 2010-09-17 2012-03-29 Baxter Healthcare S.A. STABILIZATION OF IMMUNOGLOBULINS AND OTHER PROTEINS THROUGH AQUEOUS FORMULATIONS WITH SODIUM CHLORIDE AT WEAK ACIDIC TO NEUTRAL ph
PL3777834T3 (pl) 2012-06-01 2022-05-30 Novartis Ag Strzykawka
IL312865B2 (en) 2013-09-11 2025-06-01 Eagle Biologics Inc Liquid protein formulations containing viscosity-lowering agents
AU2015325055B2 (en) 2014-10-01 2021-02-25 Eagle Biologics, Inc. Polysaccharide and nucleic acid formulations containing viscosity-lowering agents

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2738428B2 (ja) * 1987-01-08 1998-04-08 旭化成工業株式会社 トロンビンによるプロテインcの活性化を促進する作用を有するペプチド
EP0816494A1 (de) 1987-01-08 1998-01-07 Asahi Kasei Kogyo Kabushiki Kaisha DNS kodierend für ein Peptid das die Wirkung des Proteins C mit Thrombin beschleunigt und Verfahren zu dessen Herstellung
US4912207A (en) 1987-05-06 1990-03-27 Washington University DNA clone of human thrombomodulin and portions thereof
US5202421A (en) * 1988-12-27 1993-04-13 Mochida Pharmaceutical Co., Ltd. Anticoagulant substance obtained from urine and process for the preparation thereof
JPH02255699A (ja) 1989-03-28 1990-10-16 Asahi Chem Ind Co Ltd 新規血液抗凝固物質及びその製法
JPH05213998A (ja) 1990-08-03 1993-08-24 Asahi Chem Ind Co Ltd 新規なポリペプチド及びこれを有効成分とする 医薬組成物
JPH05310787A (ja) 1992-05-01 1993-11-22 Asahi Chem Ind Co Ltd 新規なポリペプチド
JP3007785B2 (ja) 1993-03-16 2000-02-07 旭化成工業株式会社 トロンボモジュリン組成物およびその変性防止方法
DE9419880U1 (de) * 1993-12-13 1995-03-02 Lisec, Peter, Amstetten-Hausmening Vorrichtung zum Teilen von Verbundglas
EP0689843B1 (de) 1993-12-17 2003-09-10 Mochida Pharmaceutical Co., Ltd. Lösliches thrombomodulin enthaltende zubereitung

Also Published As

Publication number Publication date
US6808706B1 (en) 2004-10-26
CN1275916A (zh) 2000-12-06
EP1029548A1 (de) 2000-08-23
EP1029548B1 (de) 2007-04-04
DE69837493D1 (de) 2007-05-16
CA2306206A1 (en) 1999-04-22
AU729876B2 (en) 2001-02-15
HK1027514A1 (en) 2001-01-19
ES2281137T3 (es) 2007-09-16
PT1029548E (pt) 2007-05-31
EP1029548A4 (de) 2004-07-14
KR100373480B1 (ko) 2003-02-25
ATE358496T1 (de) 2007-04-15
WO1999018994A1 (en) 1999-04-22
JP4460762B2 (ja) 2010-05-12
DE69837493T2 (de) 2007-12-13
KR20010031153A (ko) 2001-04-16
AU9460398A (en) 1999-05-03

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