JPH09512267A - 因子ix用処方 - Google Patents
因子ix用処方Info
- Publication number
- JPH09512267A JPH09512267A JP7527660A JP52766095A JPH09512267A JP H09512267 A JPH09512267 A JP H09512267A JP 7527660 A JP7527660 A JP 7527660A JP 52766095 A JP52766095 A JP 52766095A JP H09512267 A JPH09512267 A JP H09512267A
- Authority
- JP
- Japan
- Prior art keywords
- composition
- factor
- glycine
- concentration
- 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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Classifications
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- 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
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- 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)
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- 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
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- 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
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- 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
- A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
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- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Hematology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Diabetes (AREA)
- Dermatology (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
Description
Claims (1)
- 【特許請求の範囲】 1.因子IX、グリシン、および冷凍保護剤からなる組成物。 2.該冷凍保護剤がスクロースおよびマンニトールからなる群より選択される メンバーである請求項1の組成物。 3.該冷凍保護剤がスクロースである請求項1の組成物。 4.該スクロース濃度が約0.5ないし2%である請求項3の組成物。 5.該スクロース濃度が約1%である請求項4の組成物。 6.該グリシン濃度が約0.1ないし0.3Mである請求項1の組成物。 7.該グリシン濃度が約0.2ないし0.3Mである請求項6の組成物。 8.該グリシン濃度が約0.26Mである請求項7の組成物。 9.さらに塩化カルシウムからなる請求項1の組成物。 10.さらに界面活性剤からなる請求項1の組成物。 11.該界面活性剤がポリソルベートである請求項10の組成物。 12.該ポリソルベート濃度が約0.005ないし0.05%である請求項11 の組成物。 13.該ポリソルベート濃度が約0.005%である請求項11の組成物。 14.さらに緩衝化剤からなる請求項1の組成物。 15.さらに緩衝化剤からなる請求項10の組成物。 16.該緩衝化剤がヒスチジン、リン酸塩、トリス、およびジエタノールアミ ンからなる群より選択されるメンバーである請求項15の組成物。 17.該緩衝化剤がヒスチジンである請求項16の組成物。 18.該ヒスチジン濃度が約10mMである請求項17の組成物。 19.因子IX、グリシン、および緩衝化剤、冷凍保護剤ならびに界面活性剤か らなる群より選択されるメンバーからなる組成物。 20.因子IX、グリシン、ヒスチジン、およびポリソルベートからなる請求項 19の組成物。 21.因子IX、グリシン、ヒスチジン、およびスクロースからなる請求項19 の組成物。 22.さらにポリソルベートからなる請求項21の組成物。 23.因子IX、グリシン、リン酸ナトリウム、スクロース、およびポリソルベ ートからなる請求項19の組成物。 24.因子IX、グリシン、リン酸ナトリウム、およびスクロースからなる請求 項19の組成物。 25.因子IX、グリシン、リン酸カリウム、スクロース、およびポリソルベー トからなる請求項19の組成物。 26.因子IX、グリシン、リン酸カリウム、およびスクロースからなる請求項 19の組成物。 27.因子IX、グリシン、トリス、スクロース、およびポリソルベートからな る請求項19の組成物。 28.因子IX、グリシン、トリス、およびスクロースからなる請求項19の組 成物。 29.因子IX、グリシン、塩化カルシウム、ポリソルベート、およびスクロー スからなる請求項19の組成物。 30.因子IX、グリシン、トリス、塩化カルシウム、ポリソルベート、および スクロースからなる請求項19の組成物。 31.因子IX、グリシン、ジエタノールアミン、ポリソルベート、およびスク ロースからなる請求項19の組成物。 32.該因子IX濃度が約0.4ないし20mg/mlである請求項19の組成 物。 33.該因子IX濃度が約0.1ないし10mg/mlである請求項32の組成 物。 34.該因子IX濃度が約0.5ないし10mg/mlである請求項19の組成 物。 35.該グリシン濃度が約0.1ないし0.3Mである請求項19の組成物。 36.該グリシン濃度が約0.26Mである請求項35の組成物。 37.該緩衝化剤が約5ないし30mMのヒスチジンである請求項19の組成 物。 38.該ヒスチジン濃度が約10mMである請求項37の組成物。 39.該冷凍保護剤が約0.5ないし2%のスクロースである請求項19の組 成物。 40.該スクロース濃度が約1%である請求項39の組成物。 41.該界面活性剤が約0.005ないし0.05%のポリソルベートである請 求項20の組成物。 42.該ポリソルベート濃度が約0.005%である請求項41の組成物。 43.0.75mg/mlの因子IX、0.26Mグリシン、10mMヒスチジン 、1%スクロース、および0.005%ポリソルベートからなる組成物。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/233,663 | 1994-04-26 | ||
US08/233,663 US6372716B1 (en) | 1994-04-26 | 1994-04-26 | Formulations for factor IX |
PCT/US1995/004263 WO1995028954A1 (en) | 1994-04-26 | 1995-04-06 | Formulations for factor ix |
Related Child Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2006141780A Division JP4789698B2 (ja) | 1994-04-26 | 2006-05-22 | 因子ix用処方 |
JP2007156252A Division JP2007224052A (ja) | 1994-04-26 | 2007-06-13 | 因子ix用処方 |
Publications (1)
Publication Number | Publication Date |
---|---|
JPH09512267A true JPH09512267A (ja) | 1997-12-09 |
Family
ID=22878181
Family Applications (4)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP7527660A Withdrawn JPH09512267A (ja) | 1994-04-26 | 1995-04-06 | 因子ix用処方 |
JP2006141780A Expired - Lifetime JP4789698B2 (ja) | 1994-04-26 | 2006-05-22 | 因子ix用処方 |
JP2007156252A Withdrawn JP2007224052A (ja) | 1994-04-26 | 2007-06-13 | 因子ix用処方 |
JP2009267797A Withdrawn JP2010077148A (ja) | 1994-04-26 | 2009-11-25 | 因子ix用処方 |
Family Applications After (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2006141780A Expired - Lifetime JP4789698B2 (ja) | 1994-04-26 | 2006-05-22 | 因子ix用処方 |
JP2007156252A Withdrawn JP2007224052A (ja) | 1994-04-26 | 2007-06-13 | 因子ix用処方 |
JP2009267797A Withdrawn JP2010077148A (ja) | 1994-04-26 | 2009-11-25 | 因子ix用処方 |
Country Status (11)
Country | Link |
---|---|
US (1) | US6372716B1 (ja) |
EP (1) | EP0758248B1 (ja) |
JP (4) | JPH09512267A (ja) |
AT (1) | ATE244015T1 (ja) |
AU (1) | AU695084B2 (ja) |
CA (1) | CA2182200C (ja) |
DE (1) | DE69531204T2 (ja) |
DK (1) | DK0758248T3 (ja) |
ES (1) | ES2202356T3 (ja) |
PT (1) | PT758248E (ja) |
WO (1) | WO1995028954A1 (ja) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
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 |
US10370456B2 (en) | 2004-09-09 | 2019-08-06 | Genentech, Inc. | Process for concentration of antibodies and therapeutic products thereof |
Families Citing this family (77)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6372716B1 (en) * | 1994-04-26 | 2002-04-16 | Genetics Institute, Inc. | Formulations for factor IX |
US6267958B1 (en) | 1995-07-27 | 2001-07-31 | Genentech, Inc. | Protein formulation |
US5770700A (en) * | 1996-01-25 | 1998-06-23 | Genetics Institute, Inc. | Liquid factor IX formulations |
US7786070B2 (en) | 1997-09-10 | 2010-08-31 | Novo Nordisk Healthcare A/G | Subcutaneous administration of coagulation factor VII |
US20080050367A1 (en) * | 1998-04-07 | 2008-02-28 | Guriq Basi | Humanized antibodies that recognize beta amyloid peptide |
TWI239847B (en) * | 1997-12-02 | 2005-09-21 | Elan Pharm Inc | N-terminal fragment of Abeta peptide and an adjuvant for preventing and treating amyloidogenic disease |
US7790856B2 (en) * | 1998-04-07 | 2010-09-07 | Janssen Alzheimer Immunotherapy | Humanized antibodies that recognize beta amyloid peptide |
US6787523B1 (en) * | 1997-12-02 | 2004-09-07 | Neuralab Limited | Prevention and treatment of amyloidogenic disease |
US7964192B1 (en) | 1997-12-02 | 2011-06-21 | Janssen Alzheimer Immunotherapy | Prevention and treatment of amyloidgenic disease |
EP1280548B1 (en) | 2000-05-03 | 2013-12-11 | Novo Nordisk Health Care AG | Subcutaneous administration of coagulation factor VII |
AU2002225681A1 (en) * | 2000-11-15 | 2002-05-27 | Globe Immune, Inc. | Yeast-dentritic cell vaccines and uses thereof |
US7700751B2 (en) | 2000-12-06 | 2010-04-20 | Janssen Alzheimer Immunotherapy | Humanized antibodies that recognize β-amyloid peptide |
TWI255272B (en) * | 2000-12-06 | 2006-05-21 | Guriq Basi | Humanized antibodies that recognize beta amyloid peptide |
AU2002351756A1 (en) | 2001-12-21 | 2003-07-15 | Novo Nordisk Health Care Ag | Liquid composition of factor vii polypeptides |
MY139983A (en) * | 2002-03-12 | 2009-11-30 | Janssen Alzheimer Immunotherap | Humanized antibodies that recognize beta amyloid peptide |
PL207018B1 (pl) | 2002-06-21 | 2010-10-29 | Novo Nordisk Helth Care Ag | Kompozycja farmaceutyczna, sposób przygotowania stabilnego polipeptydu czynnika VII i zastosowanie polipeptydu czynnika VII |
BRPI0407058A (pt) * | 2003-02-01 | 2006-01-17 | Neuralab Ltd | Métodos de profilaxia e de tratamento de uma doença, composição farmacêutica, e, uso de um fragmento |
US7897734B2 (en) | 2003-03-26 | 2011-03-01 | Novo Nordisk Healthcare Ag | Method for the production of proteins |
KR20060015574A (ko) | 2003-05-23 | 2006-02-17 | 노보 노르디스크 헬스 케어 악티엔게젤샤프트 | 용액 중 단백질 안정화 |
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WO2004112828A1 (en) | 2003-06-25 | 2004-12-29 | Novo Nordisk Health Care Ag | Liquid composition of factor vii polypeptides |
ES2574581T3 (es) | 2003-08-14 | 2016-06-20 | Novo Nordisk Health Care Ag | Composición farmacéutica líquida acuosa de polipéptidos de tipo Factor VII |
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WO2006005058A2 (en) * | 2004-06-30 | 2006-01-12 | Nektar Therapeutics Al, Corporation | Polymer-factor ix moiety conjugates |
WO2006066089A1 (en) * | 2004-12-15 | 2006-06-22 | Neuralab Limited | Humanized amyloid beta antibodies for use in improving cognition |
JP2008524247A (ja) * | 2004-12-15 | 2008-07-10 | エラン ファーマ インターナショナル リミテッド | 認知の改善における使用のためのアミロイドβ抗体 |
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- 1994-04-26 US US08/233,663 patent/US6372716B1/en not_active Expired - Lifetime
-
1995
- 1995-04-06 AT AT95915040T patent/ATE244015T1/de active
- 1995-04-06 JP JP7527660A patent/JPH09512267A/ja not_active Withdrawn
- 1995-04-06 PT PT95915040T patent/PT758248E/pt unknown
- 1995-04-06 WO PCT/US1995/004263 patent/WO1995028954A1/en active IP Right Grant
- 1995-04-06 CA CA002182200A patent/CA2182200C/en not_active Expired - Lifetime
- 1995-04-06 DE DE69531204T patent/DE69531204T2/de not_active Expired - Lifetime
- 1995-04-06 AU AU22075/95A patent/AU695084B2/en not_active Expired
- 1995-04-06 EP EP95915040A patent/EP0758248B1/en not_active Expired - Lifetime
- 1995-04-06 ES ES95915040T patent/ES2202356T3/es not_active Expired - Lifetime
- 1995-04-06 DK DK95915040T patent/DK0758248T3/da active
-
2006
- 2006-05-22 JP JP2006141780A patent/JP4789698B2/ja not_active Expired - Lifetime
-
2007
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2009
- 2009-11-25 JP JP2009267797A patent/JP2010077148A/ja not_active Withdrawn
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US10370456B2 (en) | 2004-09-09 | 2019-08-06 | Genentech, Inc. | Process for concentration of antibodies and therapeutic products thereof |
US11767370B2 (en) | 2004-09-09 | 2023-09-26 | Genentech, Inc. | Process for concentration of antibodies and therapeutic products thereof |
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 |
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AU2207595A (en) | 1995-11-16 |
EP0758248B1 (en) | 2003-07-02 |
DK0758248T3 (da) | 2003-10-27 |
JP2010077148A (ja) | 2010-04-08 |
JP4789698B2 (ja) | 2011-10-12 |
JP2007224052A (ja) | 2007-09-06 |
JP2006219500A (ja) | 2006-08-24 |
CA2182200A1 (en) | 1995-11-02 |
US6372716B1 (en) | 2002-04-16 |
ES2202356T3 (es) | 2004-04-01 |
DE69531204D1 (de) | 2003-08-07 |
WO1995028954A1 (en) | 1995-11-02 |
ATE244015T1 (de) | 2003-07-15 |
EP0758248A1 (en) | 1997-02-19 |
AU695084B2 (en) | 1998-08-06 |
PT758248E (pt) | 2003-11-28 |
DE69531204T2 (de) | 2004-04-22 |
CA2182200C (en) | 1999-02-02 |
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