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 transportInfo
- 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
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/55—Protease inhibitors
- A61K38/57—Protease inhibitors from animals; from humans
-
- 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
- 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
- A61K47/02—Inorganic compounds
-
- 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
- A61K47/26—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
- 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
- A61K47/44—Oils, 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/745—Blood coagulation or fibrinolysis factors
- C07K14/7455—Thrombomodulin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal 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)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Hematology (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Biophysics (AREA)
- Inorganic Chemistry (AREA)
- Toxicology (AREA)
- Dermatology (AREA)
- Genetics & Genomics (AREA)
- Urology & Nephrology (AREA)
- Vascular Medicine (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Diabetes (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)
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP28165997 | 1997-10-15 | ||
JP30852397 | 1997-11-11 | ||
PCT/JP1998/004609 WO1999018994A1 (fr) | 1997-10-15 | 1998-10-13 | Procede pour conserver la qualite d'une solution parenterale aqueuse de thrombomoduline pour l'entreposage ou la 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 (14)
Country | Link |
---|---|
US (1) | US6808706B1 (fr) |
EP (1) | EP1029548B1 (fr) |
JP (1) | JP4460762B2 (fr) |
KR (1) | KR100373480B1 (fr) |
CN (1) | CN1275916A (fr) |
AT (1) | ATE358496T1 (fr) |
AU (1) | AU729876B2 (fr) |
CA (1) | CA2306206A1 (fr) |
DE (1) | DE69837493T2 (fr) |
DK (1) | DK1029548T3 (fr) |
ES (1) | ES2281137T3 (fr) |
HK (1) | HK1027514A1 (fr) |
PT (1) | PT1029548E (fr) |
WO (1) | WO1999018994A1 (fr) |
Families Citing this family (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
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 |
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 |
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 |
DE60034366T2 (de) * | 1999-12-22 | 2007-12-20 | Glaxo Group Ltd., Greenford | Verfahren zur herstellung pharmazeutischer formulierungen |
IL150736A0 (en) * | 2000-03-14 | 2003-02-12 | Mayr Anton | Altered strain of the modified vaccinia virus ankara (mva) |
WO2003061687A1 (fr) * | 2002-01-18 | 2003-07-31 | Asahi Kasei Pharma Corporation | Preparation a concentration elevee de thrombomoduline soluble |
AU2007240732B2 (en) * | 2006-04-21 | 2013-07-04 | Amgen, Inc. | Buffering agents for biopharmaceutical formulations |
AU2008230465B2 (en) | 2007-03-23 | 2011-10-13 | 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 |
KR101879885B1 (ko) | 2010-09-17 | 2018-07-18 | 박스알타 인코퍼레이티드 | 약산성 내지 중성 ph에서 히스티딘을 갖는 수성 제형을 통한 면역글로불린의 안정화 |
CN110496099B (zh) * | 2013-09-11 | 2022-06-21 | 伊戈尔生物药品股份有限公司 | 包含粘度降低剂的液体蛋白质制剂 |
MX2017004306A (es) | 2014-10-01 | 2017-12-20 | Eagle Biologics Inc | Formulaciones de polisacáridos y ácido nucleico que contienen agentes de reducción de viscosidad. |
Family Cites Families (10)
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 |
DE3856335T2 (de) | 1987-01-08 | 2000-01-27 | Asahi Chemical Ind | Peptid zur beschleunigung der wirkung des proteins-c mit thrombin |
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 |
DE59402391D1 (de) * | 1993-12-13 | 1997-05-15 | Peter Lisec | Vorrichtung zum teilen von verbundglas |
AU692497B2 (en) | 1993-12-17 | 1998-06-11 | Asahi Kasei Pharma Corporation | Soluble thrombomodulin-containing pharmaceutical composition |
-
1998
- 1998-10-13 JP JP2000515626A patent/JP4460762B2/ja not_active Expired - Fee Related
- 1998-10-13 WO PCT/JP1998/004609 patent/WO1999018994A1/fr active IP Right Grant
- 1998-10-13 AT AT98947842T patent/ATE358496T1/de active
- 1998-10-13 EP EP98947842A patent/EP1029548B1/fr not_active Expired - Lifetime
- 1998-10-13 DK DK98947842T patent/DK1029548T3/da active
- 1998-10-13 AU AU94603/98A patent/AU729876B2/en not_active Ceased
- 1998-10-13 ES ES98947842T patent/ES2281137T3/es not_active Expired - Lifetime
- 1998-10-13 CA CA002306206A patent/CA2306206A1/fr not_active Abandoned
- 1998-10-13 KR KR10-2000-7004059A patent/KR100373480B1/ko not_active IP Right Cessation
- 1998-10-13 PT PT98947842T patent/PT1029548E/pt unknown
- 1998-10-13 DE DE69837493T patent/DE69837493T2/de not_active Expired - Lifetime
- 1998-10-13 CN CN98810168A patent/CN1275916A/zh active Pending
- 1998-10-13 US US09/509,994 patent/US6808706B1/en not_active Expired - Fee Related
-
2000
- 2000-10-30 HK HK00106889A patent/HK1027514A1/xx not_active IP Right Cessation
Also Published As
Publication number | Publication date |
---|---|
EP1029548A1 (fr) | 2000-08-23 |
KR100373480B1 (ko) | 2003-02-25 |
ATE358496T1 (de) | 2007-04-15 |
PT1029548E (pt) | 2007-05-31 |
AU729876B2 (en) | 2001-02-15 |
US6808706B1 (en) | 2004-10-26 |
CA2306206A1 (fr) | 1999-04-22 |
JP4460762B2 (ja) | 2010-05-12 |
DE69837493T2 (de) | 2007-12-13 |
ES2281137T3 (es) | 2007-09-16 |
DE69837493D1 (de) | 2007-05-16 |
KR20010031153A (ko) | 2001-04-16 |
EP1029548A4 (fr) | 2004-07-14 |
WO1999018994A1 (fr) | 1999-04-22 |
EP1029548B1 (fr) | 2007-04-04 |
AU9460398A (en) | 1999-05-03 |
HK1027514A1 (en) | 2001-01-19 |
CN1275916A (zh) | 2000-12-06 |
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