DK2283856T3 - Stabiliserede, faste sammensætninger af Faktor VIIa-polypeptider - Google Patents
Stabiliserede, faste sammensætninger af Faktor VIIa-polypeptiderInfo
- Publication number
- DK2283856T3 DK2283856T3 DK10181033.1T DK10181033T DK2283856T3 DK 2283856 T3 DK2283856 T3 DK 2283856T3 DK 10181033 T DK10181033 T DK 10181033T DK 2283856 T3 DK2283856 T3 DK 2283856T3
- Authority
- DK
- Denmark
- Prior art keywords
- solid compositions
- factor viia
- stabilized solid
- viia polypeptides
- polypeptides
- Prior art date
Links
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
- A61K38/43—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
- 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
- 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)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DKPA200200963 | 2002-06-21 | ||
EP03729911.2A EP1517698B2 (en) | 2002-06-21 | 2003-06-20 | STABILISED SOLID COMPOSITIONS OF FACTOR VIIa POLYPEPTIDES |
Publications (1)
Publication Number | Publication Date |
---|---|
DK2283856T3 true DK2283856T3 (da) | 2017-11-20 |
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 Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK03729911.2T DK1517698T4 (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) | EP2283856B1 (da) |
JP (1) | JP4648002B2 (da) |
KR (2) | KR101212025B1 (da) |
CN (2) | CN1671410B (da) |
AU (1) | AU2003240438A1 (da) |
BR (1) | BRPI0311959B8 (da) |
CA (1) | CA2490342C (da) |
DK (2) | DK1517698T4 (da) |
ES (2) | ES2523655T5 (da) |
HU (1) | HUE037603T2 (da) |
IL (1) | IL165608A (da) |
PL (1) | PL207018B1 (da) |
PT (2) | PT2283856T (da) |
RU (1) | RU2366451C2 (da) |
WO (1) | WO2004000347A1 (da) |
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EP2283856B1 (en) | 2002-06-21 | 2017-09-20 | Novo Nordisk Health Care AG | Stabilised solid compositions of factor VIIa polypeptides |
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JP5306597B2 (ja) * | 2003-07-01 | 2013-10-02 | 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 | 第vii因子ポリペプチドの液体水性薬学的組成物 |
AU2011203354B2 (en) * | 2003-12-19 | 2014-07-17 | Novo Nordisk Health Care Ag | Stabilised compositions of factor VII polypeptides |
AU2004298789A1 (en) * | 2003-12-19 | 2005-06-30 | Novo Nordisk Health Care Ag | Stabilised compositions of factor VII polypeptides |
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MX2007013156A (es) * | 2005-04-28 | 2008-01-18 | Novo Nordisk Healthcare Ag | Envase cerrado que comprende un polipeptido del factor vii activado, procesos para la preparacion del mismo y kit y metodo para el uso del 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 |
CA2673260A1 (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 |
KR101578561B1 (ko) * | 2007-04-26 | 2015-12-17 | 바이엘 헬스케어 엘엘씨 | 냉동 저장을 위한, 재조합 단백질의 액상 용액의 안정화 |
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 |
AU2008269086B2 (en) | 2007-06-25 | 2014-06-12 | Amgen Inc. | Compositions of specific binding agents to hepatocyte growth factor |
CN101648012A (zh) * | 2008-04-24 | 2010-02-17 | 伊玛提克斯生物技术有限公司 | 结合到人类白细胞抗原(hla)ⅰ类或ⅱ类分子上用作疫苗的肿瘤相关肽新制剂 |
DE602008000891D1 (de) * | 2008-04-30 | 2010-05-12 | Immatics Biotechnologies Gmbh | Neuartige Formulierungen von Tumor-assoziierten Peptiden, welche an menschliche Leukozytenantigene der Klasse I oder II für Impfungen binden |
EP2348845A4 (en) | 2008-10-15 | 2013-01-23 | Infinity Pharmaceuticals 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 |
JP6487448B2 (ja) * | 2013-12-24 | 2019-03-20 | アレス トレーディング ソシエテ アノニム | アルギネート/コラーゲンヒドロゲル中のfgf−18製剤 |
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 |
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 |
US20210069306A1 (en) | 2019-08-15 | 2021-03-11 | Catalyst Biosciences, Inc. | Modified factor vii polypeptides for subcutaneous administration and on-demand treatment |
WO2023245335A1 (en) * | 2022-06-20 | 2023-12-28 | Staidson (Beijing) Biopharmaceuticals Co., Ltd . | Activators of coagulation factor x and formulations thereof for treating bleeding disorders |
CN117860874A (zh) * | 2024-03-12 | 2024-04-12 | 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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