JP2000504327A - 高度に濃縮された、凍結乾燥された、および液体の、因子▲ｉｘ▼処方 - Google Patents
高度に濃縮された、凍結乾燥された、および液体の、因子▲ｉｘ▼処方Info
- Publication number
- JP2000504327A JP2000504327A JP9526917A JP52691797A JP2000504327A JP 2000504327 A JP2000504327 A JP 2000504327A JP 9526917 A JP9526917 A JP 9526917A JP 52691797 A JP52691797 A JP 52691797A JP 2000504327 A JP2000504327 A JP 2000504327A
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- JP
- Japan
- Prior art keywords
- composition
- factor
- concentration
- arginine
- sucrose
- 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.)
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Links
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- 239000008297 liquid dosage form Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
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- 230000004001 molecular interaction Effects 0.000 description 1
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- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 108010025221 plasma protein Z Proteins 0.000 description 1
- 238000002264 polyacrylamide gel electrophoresis Methods 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 229940068965 polysorbates Drugs 0.000 description 1
- 230000004481 post-translational protein modification Effects 0.000 description 1
- XAEFZNCEHLXOMS-UHFFFAOYSA-M potassium benzoate Chemical compound [K+].[O-]C(=O)C1=CC=CC=C1 XAEFZNCEHLXOMS-UHFFFAOYSA-M 0.000 description 1
- 239000001103 potassium chloride Substances 0.000 description 1
- 235000011164 potassium chloride Nutrition 0.000 description 1
- 239000001508 potassium citrate Substances 0.000 description 1
- 229960002635 potassium citrate Drugs 0.000 description 1
- QEEAPRPFLLJWCF-UHFFFAOYSA-K potassium citrate (anhydrous) Chemical compound [K+].[K+].[K+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O QEEAPRPFLLJWCF-UHFFFAOYSA-K 0.000 description 1
- 235000011082 potassium citrates Nutrition 0.000 description 1
- 229910000160 potassium phosphate Inorganic materials 0.000 description 1
- 235000011009 potassium phosphates Nutrition 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 238000007639 printing Methods 0.000 description 1
- 108090000765 processed proteins & peptides Proteins 0.000 description 1
- 239000003223 protective agent Substances 0.000 description 1
- 229960000856 protein c Drugs 0.000 description 1
- 230000006920 protein precipitation Effects 0.000 description 1
- 238000001742 protein purification Methods 0.000 description 1
- 239000012460 protein solution Substances 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 229920005989 resin Polymers 0.000 description 1
- 239000011347 resin Substances 0.000 description 1
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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
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
- A61K38/482—Serine endopeptidases (3.4.21)
- A61K38/4846—Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Y—ENZYMES
- C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
- C12Y304/21—Serine endopeptidases (3.4.21)
- C12Y304/21022—Coagulation factor IXa (3.4.21.22)
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Wood Science & Technology (AREA)
- Dermatology (AREA)
- Zoology (AREA)
- Immunology (AREA)
- Gastroenterology & Hepatology (AREA)
- Molecular Biology (AREA)
- General Engineering & Computer Science (AREA)
- Genetics & Genomics (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Hematology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/591,332 US5770700A (en) | 1996-01-25 | 1996-01-25 | Liquid factor IX formulations |
| US08/591,332 | 1996-01-25 | ||
| PCT/US1997/000747 WO1997026909A1 (en) | 1996-01-25 | 1997-01-09 | Highly concentrated, lyophilized, and liquid factor ix formulations |
Related Child Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2006141684A Division JP2006257099A (ja) | 1996-01-25 | 2006-05-22 | 高度に濃縮された、凍結乾燥された、および液体の、因子ｉｘ処方 |
| JP2007180835A Division JP4879104B2 (ja) | 1996-01-25 | 2007-07-10 | 高度に濃縮された、凍結乾燥された、および液体の、因子ｉｘ処方 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2000504327A true JP2000504327A (ja) | 2000-04-11 |
| JP2000504327A5 JP2000504327A5 (OSRAM) | 2004-10-28 |
Family
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Family Applications (4)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP9526917A Withdrawn JP2000504327A (ja) | 1996-01-25 | 1997-01-09 | 高度に濃縮された、凍結乾燥された、および液体の、因子▲ｉｘ▼処方 |
| JP2006141684A Pending JP2006257099A (ja) | 1996-01-25 | 2006-05-22 | 高度に濃縮された、凍結乾燥された、および液体の、因子ｉｘ処方 |
| JP2007180835A Expired - Lifetime JP4879104B2 (ja) | 1996-01-25 | 2007-07-10 | 高度に濃縮された、凍結乾燥された、および液体の、因子ｉｘ処方 |
| JP2010106673A Withdrawn JP2010189433A (ja) | 1996-01-25 | 2010-05-06 | 高度に濃縮された、凍結乾燥された、および液体の、因子ｉｘ処方 |
Family Applications After (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2006141684A Pending JP2006257099A (ja) | 1996-01-25 | 2006-05-22 | 高度に濃縮された、凍結乾燥された、および液体の、因子ｉｘ処方 |
| JP2007180835A Expired - Lifetime JP4879104B2 (ja) | 1996-01-25 | 2007-07-10 | 高度に濃縮された、凍結乾燥された、および液体の、因子ｉｘ処方 |
| JP2010106673A Withdrawn JP2010189433A (ja) | 1996-01-25 | 2010-05-06 | 高度に濃縮された、凍結乾燥された、および液体の、因子ｉｘ処方 |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US5770700A (OSRAM) |
| EP (1) | EP0876155B1 (OSRAM) |
| JP (4) | JP2000504327A (OSRAM) |
| AT (1) | ATE270557T1 (OSRAM) |
| AU (1) | AU726498B2 (OSRAM) |
| CA (1) | CA2241319A1 (OSRAM) |
| DE (1) | DE69729786T2 (OSRAM) |
| WO (1) | WO1997026909A1 (OSRAM) |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2005516998A (ja) * | 2002-02-06 | 2005-06-09 | メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフトング | 免疫サイトカイン含有凍結乾燥製剤 |
| JP2007262090A (ja) * | 1996-01-25 | 2007-10-11 | Genetics Inst Llc | 高度に濃縮された、凍結乾燥された、および液体の、因子ｉｘ処方 |
| JP2009161538A (ja) * | 2001-03-05 | 2009-07-23 | Bayer Schering Pharma Ag | 顆粒球マクロファージ・コロニー刺激因子の安定性のある水溶液 |
| JP2010530846A (ja) * | 2007-06-01 | 2010-09-16 | アコロジックス インコーポレイティッド | 高温で安定なペプチド製剤 |
| JP2012500041A (ja) * | 2008-08-15 | 2012-01-05 | ヘムコン メディカル テクノロジーズ， インコーポレイテッド | 凍結乾燥物質、例えば凍結乾燥血漿を製造、貯蔵、および投与するための装置およびシステム |
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| US20080050367A1 (en) * | 1998-04-07 | 2008-02-28 | Guriq Basi | Humanized antibodies that recognize beta amyloid peptide |
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| EP2039368A3 (en) | 1999-04-30 | 2009-04-01 | La Jolla Institute For Allergy And Immunology | Methods for preventing reactivation of latent virus and controlling virus replication |
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| JP7471316B2 (ja) | 2019-03-14 | 2024-04-19 | テルモ ビーシーティー バイオテクノロジーズ，エルエルシー | マルチパート凍結乾燥容器 |
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| US4952675A (en) * | 1985-02-01 | 1990-08-28 | New York University | Method for purifying antihemophilic factor |
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| JP2577744B2 (ja) * | 1986-07-18 | 1997-02-05 | 中外製薬株式会社 | 安定な顆粒球コロニ−刺激因子含有製剤 |
| DE3729863A1 (de) * | 1987-09-05 | 1989-03-16 | Boehringer Mannheim Gmbh | Stabilisierte erythropoietin-lyophilisate |
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| DE3828009A1 (de) * | 1988-08-18 | 1990-02-22 | Wolfgang D Zapp | Rahmen aus strangprofilen |
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| DE3939346A1 (de) * | 1989-11-29 | 1991-06-06 | Behringwerke Ag | Arzneimitel zur subkutanen oder intramuskulaeren applikation enthaltend polypeptide |
| DE4001451A1 (de) * | 1990-01-19 | 1991-08-01 | Octapharma Ag | Stabile injizierbare loesungen von faktor viii und faktor ix |
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-
1996
- 1996-01-25 US US08/591,332 patent/US5770700A/en not_active Expired - Lifetime
-
1997
- 1997-01-09 WO PCT/US1997/000747 patent/WO1997026909A1/en not_active Ceased
- 1997-01-09 JP JP9526917A patent/JP2000504327A/ja not_active Withdrawn
- 1997-01-09 EP EP97904797A patent/EP0876155B1/en not_active Expired - Lifetime
- 1997-01-09 CA CA002241319A patent/CA2241319A1/en not_active Abandoned
- 1997-01-09 AU AU17500/97A patent/AU726498B2/en not_active Ceased
- 1997-01-09 AT AT97904797T patent/ATE270557T1/de not_active IP Right Cessation
- 1997-01-09 DE DE69729786T patent/DE69729786T2/de not_active Expired - Lifetime
-
2006
- 2006-05-22 JP JP2006141684A patent/JP2006257099A/ja active Pending
-
2007
- 2007-07-10 JP JP2007180835A patent/JP4879104B2/ja not_active Expired - Lifetime
-
2010
- 2010-05-06 JP JP2010106673A patent/JP2010189433A/ja not_active Withdrawn
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2007262090A (ja) * | 1996-01-25 | 2007-10-11 | Genetics Inst Llc | 高度に濃縮された、凍結乾燥された、および液体の、因子ｉｘ処方 |
| JP2009161538A (ja) * | 2001-03-05 | 2009-07-23 | Bayer Schering Pharma Ag | 顆粒球マクロファージ・コロニー刺激因子の安定性のある水溶液 |
| JP2005516998A (ja) * | 2002-02-06 | 2005-06-09 | メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフトング | 免疫サイトカイン含有凍結乾燥製剤 |
| JP2010530846A (ja) * | 2007-06-01 | 2010-09-16 | アコロジックス インコーポレイティッド | 高温で安定なペプチド製剤 |
| JP2012500041A (ja) * | 2008-08-15 | 2012-01-05 | ヘムコン メディカル テクノロジーズ， インコーポレイテッド | 凍結乾燥物質、例えば凍結乾燥血漿を製造、貯蔵、および投与するための装置およびシステム |
Also Published As
| Publication number | Publication date |
|---|---|
| WO1997026909A1 (en) | 1997-07-31 |
| ATE270557T1 (de) | 2004-07-15 |
| JP2010189433A (ja) | 2010-09-02 |
| DE69729786T2 (de) | 2005-07-14 |
| CA2241319A1 (en) | 1997-07-31 |
| JP2007262090A (ja) | 2007-10-11 |
| DE69729786D1 (de) | 2004-08-12 |
| AU1750097A (en) | 1997-08-20 |
| EP0876155B1 (en) | 2004-07-07 |
| US5770700A (en) | 1998-06-23 |
| JP2006257099A (ja) | 2006-09-28 |
| AU726498B2 (en) | 2000-11-09 |
| JP4879104B2 (ja) | 2012-02-22 |
| EP0876155A1 (en) | 1998-11-11 |
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