DK1517698T3 - Stabiliserede faste sammensætninger af Faktor VIIa-polypeptider - Google Patents
Stabiliserede faste sammensætninger af Faktor VIIa-polypeptider Download PDFInfo
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- DK1517698T3 DK1517698T3 DK03729911.2T DK03729911T DK1517698T3 DK 1517698 T3 DK1517698 T3 DK 1517698T3 DK 03729911 T DK03729911 T DK 03729911T DK 1517698 T3 DK1517698 T3 DK 1517698T3
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- 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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- 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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- 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
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- 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
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- 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
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- 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
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- 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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- 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
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
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- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
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- 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)
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Claims (32)
1. Sammensætning omfattende et Faktor VI la-polypeptid og en kombination af sukrose og en polyol valgt fra gruppen bestående af mannitol, sorbitol og xylitol, hvori polyol er til stedet i et vægtforhold i forhold til sukrose i området fra 10:1 til 1:2; hvilken sammensætning har et fugtindhold på ikke mere end 3%.
2. Sammensætning ifølge krav 1, hvori kombinationen af sukrose og en polyol yderligere omfatter en antioxidant valgt fra gruppen bestående af homocystein, cystein, cystathionin, methionin, gluthation, og peptider indeholdende enhver af homocystein, cystein, cystathionin, methionin og gluthation.
3. Sammensætning ifølge ethvert af de foregående krav, hvori polyol er til stede i en mængde i området fra 0,5 til 75 mg/ml, såsom fra 2 til 60 mg/ml, 5 mg/ml til 55 mg/ml, 8 til 45 mg/ml, 10 til 40 mg/ml, 10 til 30 mg/ml, eller fra 2 til 45 mg/ml, 5 mg/ml til 45 mg/ml, 5 til 35 mg/ml, 5 til 25 mg/ml, 5 til 20 mg/ml, 20 til 40 mg/ml, eller såsom fra 20 til 30 mg/ml.
4. Sammensætning ifølge ethvert af de foregående krav, hvori sukrose er til stede i en mængde i området fra 0,5 til 75 mg/ml, såsom fra 2 til 60 mg/ml, fra 5 mg/ml til 55 mg/ml, fra 8 til 45 mg/ml, fra 10 til 40 mg/ml, fra 10 til 30 mg/ml, eller fra 2 til 45 mg/ml, fra 5 mg/ml til 45 mg/ml, fra 5 til 35 mg/ml, fra 5 til 25 mg/ml, såsom fra 5 til 20 mg/ml.
5. Sammensætning ifølge ethvert af de foregående krav, hvori polyol er i et vægtforhold i forhold til sukrose i området fra 6:1 til 1:2; 4:1 til 1:1; eller fra 4:1 til 3:2.
6. Sammensætning ifølge ethvert af de foregående krav, yderligere omfattende et middel egnet til at holde sammensætningens pH i området 3 til 9, når det er opløst i et vandigt opløsningsmiddel, hvor pH fortrinsvis er i området 4 til 7, mere fortrukket i området 4,5 til 6,5, endda mere foretrukket i området 5 til 6, hvori midlet er valgt fra gruppen bestående af citrat, acetat, histidin, malat, fosfat, vinsyre, ravsyre, MES, HEPES, PIPES, imidazol, TRIS, laktat, glutamat og glycyl-glycin.
7. Sammensætning ifølge ethvert af de foregående krav, yderligere omfattende en tonicitetsmodifikator valgt fra gruppen bestående af natriumacetat, natrium- laktat, natriumklorid, kaliumklorid og kalciumklorid.
8. Sammensætning ifølge ethvert af de foregående krav, yderligere omfattende et afspændingsmiddel valgt fra gruppen bestående af polysorbater, polyoxyetylenal-kylætere eller poloxamere, og andre etylen-/polypropylenblokpolymere eller poly-etylenglykol (PEG).
9. Sammensætning ifølge krav 8, hvori afspændingsmidlet er valg fra gruppen: polysorbat 20, polysorbat 80, Brij 35®, Poloxamer 188 eller Poloxamer 407 og PEG8000.
10. Sammensætning ifølge ethvert af de foregående krav, hvori polyolen er mannitol.
11. Sammensætning ifølge ethvert af de foregående krav, hvori Faktor VIIa-polypeptidet er valgt fra gruppen bestående af Fluman Faktor Vila, Rekombinant Human Faktor VI la og en Faktor VII Sekvens Variant.
12. Sammensætning ifølge krav 11, hvori Faktor VIIa-polypeptid er Human Faktor Vila eller Rekombinant Human Faktor Vila.
13. Sammensætning ifølge ethvert af krav 11-12, hvori Faktor VI la-polypeptidet er til stede i en koncentration fra 0,6 mg/ml til 10,0 mg/ml, såsom fra 0,6 mg/ml til 6 mg/ml, fra 0.6 mg/ml til 5 mg/ml, eller fra 0.6 mg/ml til 4 mg/ml.
14. Sammensætning ifølge ethvert af de foregående krav, hvori fugtindholdet ikke er mere end 2,5 vægt-%, ikke mere end 2 vægt-%, eller ikke mere end 1,5 vægt-%.
15. Sammensætning ifølge ethvert af de foregående krav, hvori sammensætningen er en frysetørret kage.
16. Sammensætning ifølge ethvert af de foregående krav, hvori sammensætningen omfatter: Faktor VI la-polypeptid, Mannitol, Sukrose og et afspændingsmiddel valgt blandt et polysorbat eller en poloxamer, såsom Tween 80® eller Poloxamer 188®.
17. Sammensætning ifølge krav 16, som yderligere indeholder methionin.
18. Sammensætning ifølge ethvert af krav 16-17, som yderligere indeholder L-histidin.
19. Sammensætning ifølge ethvert af krav 16-18, som yderligere indeholder en eller flere komponenter valgt fra gruppen: CaCI2, NaCI og Glycylglycin.
20. Sammensætning ifølge ethvert af de foregående krav, hvori sammensætningen er valgt mellem formuleringerne A og D:
21. Sammensætning ifølge ethvert af de foregående krav, hvori sammensætningen er valgt fra listen af formuleringer Ex til Lx:
22. Sammensætninger ifølge ethvert af krav 16-21, hvori Faktor VIIa-polypeptidet er human Faktor Vila.
23. Fremgangsmåde til fremstilling af et stabilt Faktor VI la-polypeptid omfattende trinene: i) tilvejebringelse af Faktor VI la-polypeptid i en opløsning omfattende en kombination af sukrose og en polyol valgt fra gruppen bestående af mannitol, sorbitol og xylitol, hvori polyolen er til stedet i et vægtforhold i forhold til sukrose i området fra 10:1 til 1:2; ii) frysetørring af opløsningen for derved at opnå en fast sammensætning med et fugtindhold på ikke mere end 3 vægt-%.
24. Fremgangsmåde ifølge krav 23, yderligere omfattende en antioxidant valgt fra gruppen bestående af homocystein, cystein, cystathionin, methionin, gluthation og peptider indeholdende enhver af homocystein, cystein, cystathionin, methionin og gluthation.
25. Fremgangsmåde ifølge ethvert af krav 23-24, hvori polyol er til stede i en mængde i området fra 0,5 til 75 mg/ml, fortrinsvis fra 2 til 45 mg/ml, såsom fra 5 mg/ml til 45 mg/ml, fra 5 til 35 mg/ml, fra 5 til 25 mg/ml, 5 til 20 mg/ml, 20 til 40 mg/ml, eller fra 20 til 30 mg/ml.
26. Fremgangsmåde ifølge ethvert af krav 23-25, hvori sukrose er til stede i en mængde i området fra 0,5 til 75 mg/ml, fortrinsvis fra 2 til 45 mg/ml, såsom fra 5 mg/ml til 45 mg/ml, fra 5 til 35 mg/ml, fra 5 til 25 mg/ml, eller fra 5 til 20 mg/ml.
27. Fremgangsmåde ifølge ethvert af krav 23-26, hvori antioxidanten er i en mængde fra 0,05 til 10 mg/ml, fortrinsvis fra 0,1 til 5 mg/ml, mere foretrukket fra 0,1 mg/ml til 2,5 mg/ml, endda mere foretrukket fra 0,1 til 2 mg/ml, mest foretrukket fra 0,1 til 1 mg/ml.
28. Fremgangsmåde ifølge ethvert af krav 23-27, hvori antioxidanten er methionin.
29. Fremgangsmåde ifølge ethvert af krav 23-28, hvori polyolen er mannitol.
30. Anvendelse af Faktor VI la-polypeptid til fremstilling af et medikament til brug i en fremgangsmåde til behandling af et Factor VI l-responsivt syndrom, hvori syndromet er valgt fra gruppen bestående af hæmofili A, hæmofili B, Faktor XI- mangel, Factor Vll-mangel, thrombocytopeni, von Willebrands sygdom, tilstedeværelse af en koaguleringsfaktorhæmmer, operation, traume og antikoagulering-sterapi, hvilket medikament omfatter en sammensætning omfattende: et Faktor VIIa-polypeptid og en kombination af sukrose og et polyol valgt fra gruppen bestående af mannitol, sorbitol og xylitol, hvori polyolen er til stedet i et vægtforhold i forhold til sukrose i området fra 10:1 til 1:2; hvilken sammensætning har et fugtindhold på ikke mere end 3%.
31. Anvendelse ifølge krav 30, hvori sammensætningen er som defineret i ethvert af krav 1 til 24.
32. Sammensætning som beskrevet i ethvert af krav 1-22 til anvendelse i en fremgangsmåde til behandling af et Faktor VII-responsivt syndrom, hvori syndromet er valgt fra gruppen bestående af hæmofili A, hæmofili B, Faktor XI-mangel, Faktor Vll-mangel, thrombocytopeni, von Willebrands sygdom, tilstedeværelse af en koaguleringsfaktorhæmmer, operation, traume og antikoagulering-sterapi.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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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 |
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DK1517698T3 true DK1517698T3 (da) | 2014-11-24 |
DK1517698T4 DK1517698T4 (da) | 2018-01-29 |
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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 |
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DK10181033.1T DK2283856T3 (da) | 2002-06-21 | 2003-06-20 | Stabiliserede, faste sammensætninger af Faktor VIIa-polypeptider |
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US (11) | US20040248793A1 (da) |
EP (2) | EP2283856B1 (da) |
JP (1) | JP4648002B2 (da) |
KR (2) | KR101212025B1 (da) |
CN (2) | CN101912601B (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) |
Families Citing this family (36)
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US20040247607A1 (en) * | 1999-11-08 | 2004-12-09 | Novus International, Inc. | Use of surfactants to stabilize oocysts |
EP1458408B1 (en) | 2001-12-21 | 2009-04-15 | Novo Nordisk Health Care AG | Liquid composition of factor vii polypeptides |
CN101912601B (zh) | 2002-06-21 | 2012-08-29 | 诺和诺德医疗保健公司 | 因子vii多肽的稳定化固体组合物 |
JP4658041B2 (ja) | 2003-06-25 | 2011-03-23 | 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因子ポリペプチドの液体組成物 |
ATE446768T1 (de) * | 2003-07-01 | 2009-11-15 | Novo Nordisk Healthcare Ag | Flüssige wässrige pharmazeutische zusammnesetzung von factor vii polypeptiden |
EP2311437A1 (en) * | 2003-12-19 | 2011-04-20 | Novo Nordisk Health Care AG | Stabilised compositions of factor VII polypeptides |
AU2011203354B2 (en) * | 2003-12-19 | 2014-07-17 | Novo Nordisk Health Care Ag | Stabilised compositions of factor VII polypeptides |
DK1716119T3 (da) | 2003-12-23 | 2013-06-10 | Infinity Discovery Inc | Analoger af benzoquinonholdige ansamyciner til behandling af cancer |
BRPI0510295A (pt) † | 2004-05-04 | 2007-11-06 | Novo Nordisk Healthcare Ag | preparação de uma glicoproteìna, e, método para produzir a mesma |
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 |
BRPI0608170A2 (pt) * | 2005-04-28 | 2010-11-09 | Novo Nordisk Healthcare Ag | recipiente fechado contendo uma composição de um polipeptìdeo do fator vii ativado, processo para a preparação de um recipiente fechado contendo um polipeptìdeo do fator vii ativado, kit, e, método para a preparação de uma composição farmacêutica |
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 |
BRPI0810835A2 (pt) * | 2007-04-12 | 2015-06-16 | Infinity Discovery Inc | Formulações de hidroquinona ansamicina |
RU2469739C2 (ru) | 2007-04-26 | 2012-12-20 | БАЙЕР ХЕЛСКЕА ЛЛСи | Стабилизация жидких растворов рекомбинантного белка для хранения в замороженном состоянии |
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