DK1517698T4 - Stabiliserede faste sammensætninger af Faktor VIIa-polypeptider - Google Patents
Stabiliserede faste sammensætninger af Faktor VIIa-polypeptiderInfo
- Publication number
- DK1517698T4 DK1517698T4 DK03729911.2T DK03729911T DK1517698T4 DK 1517698 T4 DK1517698 T4 DK 1517698T4 DK 03729911 T DK03729911 T DK 03729911T DK 1517698 T4 DK1517698 T4 DK 1517698T4
- Authority
- DK
- Denmark
- Prior art keywords
- solid compositions
- factor viia
- stabilized solid
- viia polypeptides
- polypeptides
- Prior art date
Links
- 229920001184 polypeptide Polymers 0.000 title abstract 2
- 102000004196 processed proteins & peptides Human genes 0.000 title abstract 2
- 108090000765 processed proteins & peptides Proteins 0.000 title abstract 2
- 108010054265 Factor VIIa Proteins 0.000 title 1
- 229940012414 factor viia Drugs 0.000 title 1
- 239000008247 solid mixture Substances 0.000 title 1
- 102100023804 Coagulation factor VII Human genes 0.000 abstract 2
- 108010023321 Factor VII Proteins 0.000 abstract 2
- 229940012413 factor vii Drugs 0.000 abstract 2
- 239000000203 mixture Substances 0.000 abstract 2
Classifications
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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
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/36—Blood coagulation or fibrinolysis factors
-
- 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
- A61K47/02—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
-
- 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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- 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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
-
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- 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
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
-
- 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)
- C12Y304/21021—Coagulation factor VIIa (3.4.21.21)
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Organic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Hematology (AREA)
- Inorganic Chemistry (AREA)
- Immunology (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Molecular Biology (AREA)
- General Engineering & Computer Science (AREA)
- Wood Science & Technology (AREA)
- Genetics & Genomics (AREA)
- Dermatology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DKPA200200963 | 2002-06-21 | ||
| US39415302P | 2002-07-03 | 2002-07-03 | |
| PCT/DK2003/000419 WO2004000347A1 (en) | 2002-06-21 | 2003-06-20 | Stabilised solid compositions of factor vii polypeptides |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| DK1517698T3 DK1517698T3 (da) | 2014-11-24 |
| DK1517698T4 true DK1517698T4 (da) | 2018-01-29 |
Family
ID=34178323
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK03729911.2T DK1517698T4 (da) | 2002-06-21 | 2003-06-20 | Stabiliserede faste sammensætninger af Faktor VIIa-polypeptider |
| DK10181033.1T DK2283856T3 (da) | 2002-06-21 | 2003-06-20 | Stabiliserede, faste sammensætninger af Faktor VIIa-polypeptider |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK10181033.1T DK2283856T3 (da) | 2002-06-21 | 2003-06-20 | Stabiliserede, faste sammensætninger af Faktor VIIa-polypeptider |
Country Status (16)
| Country | Link |
|---|---|
| US (11) | US20040248793A1 (da) |
| EP (2) | EP1517698B2 (da) |
| JP (1) | JP4648002B2 (da) |
| KR (2) | KR20050013148A (da) |
| CN (2) | CN1671410B (da) |
| AU (1) | AU2003240438A1 (da) |
| BR (1) | BRPI0311959B8 (da) |
| CA (1) | CA2490342C (da) |
| DK (2) | DK1517698T4 (da) |
| ES (2) | ES2653555T3 (da) |
| HU (1) | HUE037603T2 (da) |
| IL (1) | IL165608A (da) |
| PL (1) | PL207018B1 (da) |
| PT (2) | PT1517698E (da) |
| RU (1) | RU2366451C2 (da) |
| WO (1) | WO2004000347A1 (da) |
Families Citing this family (38)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20040247607A1 (en) * | 1999-11-08 | 2004-12-09 | Novus International, Inc. | Use of surfactants to stabilize oocysts |
| AU2002351756A1 (en) | 2001-12-21 | 2003-07-15 | Novo Nordisk Health Care Ag | Liquid composition of factor vii polypeptides |
| PT1517698E (pt) | 2002-06-21 | 2014-11-19 | Novo Nordisk Healthcare Ag | Composições sólidas estabilizadas de polipéptidos do fator viia |
| WO2004112828A1 (en) | 2003-06-25 | 2004-12-29 | Novo Nordisk Health Care Ag | Liquid composition of factor vii polypeptides |
| EP1644030B1 (en) * | 2003-07-01 | 2009-10-28 | Novo Nordisk Health Care AG | Liquid, aqueous pharmaceutical composition of factor vii polypeptides |
| RU2373953C2 (ru) * | 2003-12-19 | 2009-11-27 | Ново Нордиск Хелс Кеа Аг | Стабилизированная композиция, содержащая полипептид фактора vii |
| AU2011203354B2 (en) * | 2003-12-19 | 2014-07-17 | Novo Nordisk Health Care Ag | Stabilised compositions of factor VII polypeptides |
| BRPI0418147A (pt) | 2003-12-23 | 2007-04-17 | Infinity Pharmaceuticals Inc | análogos de ansamicinas contendo benzoquinona e seus métodos de uso |
| ES2339953T5 (es) † | 2004-05-04 | 2020-05-06 | Novo Nordisk Healthcare Ag | Glicoformas de factor VII ligadas a O y método de fabricación |
| JP2008531523A (ja) * | 2005-02-24 | 2008-08-14 | ノボ ノルディスク ヘルス ケア アクチェンゲゼルシャフト | Vii因子ポリペプチド製剤を安定化する化合物 |
| WO2006114448A2 (en) * | 2005-04-28 | 2006-11-02 | Novo Nordisk Health Care Ag | A closed container comprising an activated factor vii polypeptide, processes for the preparation of the same, and a kit and a method for use of the kit |
| AU2012213951B2 (en) * | 2005-04-28 | 2014-10-16 | Novo Nordisk Health Care Ag | A closed container comprising an activated factor VII polypeptide, processes for the preparation of the same, and a kit and a method for use of the kit |
| US8137677B2 (en) * | 2005-10-06 | 2012-03-20 | Allergan, Inc. | Non-protein stabilized clostridial toxin pharmaceutical compositions |
| ES2257225B1 (es) * | 2006-02-17 | 2007-03-16 | Grifols, S.A | Preparacion terapeutica de fviia de muy alta pureza y metodo para su obtencion. |
| TW200806317A (en) * | 2006-03-20 | 2008-02-01 | Wyeth Corp | Methods for reducing protein aggregation |
| CN100486641C (zh) * | 2006-08-11 | 2009-05-13 | 南京师范大学 | 口服复方骨肽药物组合物及其制备方法 |
| WO2008078189A2 (en) * | 2006-12-20 | 2008-07-03 | Bayer Healthcare Llc | Factor vii and viia compositions |
| US20080255080A1 (en) * | 2007-04-12 | 2008-10-16 | Wright James L | Hydroquinone Ansamycin Formulations |
| RU2469739C2 (ru) * | 2007-04-26 | 2012-12-20 | БАЙЕР ХЕЛСКЕА ЛЛСи | Стабилизация жидких растворов рекомбинантного белка для хранения в замороженном состоянии |
| US9186323B2 (en) | 2007-05-02 | 2015-11-17 | Novo Nordisk Healthcare Ag | High concentration factor VII polypeptide formulations comprising an aromatic preservative and an antioxidant |
| EP2170268A2 (en) | 2007-06-25 | 2010-04-07 | Amgen, Inc. | Compositions of specific binding agents to hepatocyte growth factor |
| UA104572C2 (ru) * | 2008-04-24 | 2014-02-25 | Имматикс Байотекнолоджиз Гмбх | Новые композиции опухолеассоциированных пептидов, которые связываются с молекулами i или ii класса лейкоцитарного антигена человека (hla) для разработки вакцин |
| PT2113253E (pt) * | 2008-04-30 | 2010-06-15 | Immatics Biotechnologies Gmbh | Formulações novas de peptídeos associados a tumores que se ligam a moléculas de classe i ou ii do antígeno leucocitário humano (hla) para vacinas |
| WO2010045442A1 (en) | 2008-10-15 | 2010-04-22 | Infinity Discovery, Inc. | Ansamycin hydroquinone compositions |
| FR2947181B1 (fr) | 2009-06-26 | 2012-05-04 | Lfb Biotechnologies | Composition de facteur vii |
| EP2364690A1 (en) | 2010-02-12 | 2011-09-14 | Centro De Ingenieria Genetica Y Biotecnologia | Orally administrable pharmaceutical pellet of epidermal growth factor |
| CN102441172B (zh) * | 2011-12-06 | 2014-05-07 | 中国医学科学院输血研究所 | 高纯度凝血酶原复合物制品冷冻干燥稳定剂 |
| US8883979B2 (en) | 2012-08-31 | 2014-11-11 | Bayer Healthcare Llc | Anti-prolactin receptor antibody formulations |
| NZ721597A (en) * | 2013-12-24 | 2022-07-01 | Ares Trading Sa | Fgf-18 formulation in alginate/collagen hydrogels |
| CN104826117B (zh) * | 2015-05-05 | 2017-11-14 | 广东卫伦生物制药有限公司 | 用于人体血清免疫球蛋白溶液制剂的储存稳定剂 |
| CN105424946B (zh) * | 2015-07-16 | 2016-08-24 | 青岛古高生物科技有限公司 | 一种含迷迭香酸的凝血酶时间测定试剂 |
| KR20260046164A (ko) | 2015-07-30 | 2026-04-06 | 바이오마린 파머수티컬 인크. | 골 이형성증 치료를 위한 c―형 나트륨이뇨 펩타이드 변이체의 용도 |
| CN106139127B (zh) * | 2016-08-05 | 2020-04-07 | 无锡药明生物技术股份有限公司 | 重组凝血因子ⅷ冻干制剂 |
| AR109621A1 (es) * | 2016-10-24 | 2018-12-26 | Janssen Pharmaceuticals Inc | Formulaciones de vacunas contra glucoconjugados de expec |
| CN112138149A (zh) * | 2019-06-28 | 2020-12-29 | 北京基科晟斯医药科技有限公司 | 重组凝血因子viii制剂 |
| WO2021030787A1 (en) | 2019-08-15 | 2021-02-18 | Catalyst Biosciences, Inc. | Modified factor vii polypeptides for subcutaneous administration and on-demand treatment |
| CN119698300A (zh) * | 2022-06-20 | 2025-03-25 | 江苏贝捷泰生物科技有限公司 | 凝血因子x激活剂及其用于治疗出血性疾病的制剂 |
| CN117860874B (zh) * | 2024-03-12 | 2024-07-02 | 正大天晴药业集团南京顺欣制药有限公司 | 重组人凝血因子VIIa的药物组合物 |
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2003
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- 2003-06-20 KR KR10-2004-7020858A patent/KR20050013148A/ko not_active Ceased
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