DK2298287T3 - Stabiliserede sammensætninger af faktor VII-polypeptider - Google Patents
Stabiliserede sammensætninger af faktor VII-polypeptider Download PDFInfo
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- DK2298287T3 DK2298287T3 DK10181045.5T DK10181045T DK2298287T3 DK 2298287 T3 DK2298287 T3 DK 2298287T3 DK 10181045 T DK10181045 T DK 10181045T DK 2298287 T3 DK2298287 T3 DK 2298287T3
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- fvii
- composition
- factor
- unit form
- factor vii
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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
- 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
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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
- A61K38/37—Factors VIII
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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)
-
- 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)
- A61K38/4866—Protein C (3.4.21.69)
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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
- 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
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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
- 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
- A61K9/08—Solutions
-
- 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
- A61P17/00—Drugs for dermatological disorders
- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
-
- 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
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- 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)
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Hematology (AREA)
- Zoology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Dermatology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Diabetes (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Inorganic Chemistry (AREA)
- Toxicology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
Claims (6)
1. Kit indeholdende et farmaceutisk lægemiddel, hvor nævnte kit omfatter: a) i en første enhedsform, en sammensætning omfattende 1.0 mg/ml_ af rekombinant faktor Vlla, 2.34 mg/mL af natriumchlorid, 1.47 mg/mL af calciumchlorid, 2ΗιΟ, 0,07 mg/mL af polysorbat 80, 0,5 mg/mL af methionin, 25 mg/mL af mannitol, 10 mg/mL af sukrose, hvor sammensætningen har et fugtindhold på ikke mere end 3 %; og beholderorgan til at indeholde nævnte første enhedsform; og, b) i en anden enhedsform, et administrationsvehikel omfattende fra 0,5 mg/mL til 3 mg/mL af L-histidin egnet til at fastholde pH'en af nævnte sammensætning ved pH 6,0 når opløst i vandigt solvent; og beholderorgan til at indeholde nævnte anden enhedsform.
2. Kit ifølge krav 1, hvilket kit omfatter: a) i en første enhedsform, en sammensætning omfattende 1.0 mg/mL af rekombinant faktor Vlla, 2.34 mg/mL af natriumchlorid, 1.47 mg/mL af calciumchlorid, 2H2O, 1,32 mg/mL af glycylglycin, 0,07 mg/mL af polysorbat 80, 0,5 mg/mL af methionin, 25 mg/mL af mannitol, 10 mg/mL af sukrose, hvor sammensætningen har et fugtindhold på ikke mere end 3 %; og beholderorgan til at indeholde nævnte første enhedsform; og, b) i en anden enhedsform, et administrationsvehikel omfattende fra 0,5 mg/mL til 3 mg/mL af L-histidin egnet til at fastholde pH'en af nævnte sammensætning ved pH 6,0 når opløst i vandigt solvent; og beholderorgan til at indeholde nævnte anden enhedsform.
3. Kit ifølge krav 1, hvilket kit omfatter: a) i en første enhedsform, en sammensætning bestående af 1.0 mg/mL af rekombinant faktor Vlla, 2.34 mg/mL af natriumchlorid, 1,47 mg/mL af calciumchlorid, 2H2O, 0,07 mg/mL af polysorbat 80, 0,5 mg/mL af methionin, 25 mg/mL af mannitol, 10 mg/mL af sukrose, hvor sammensætningen har et fugtindhold på ikke mere end 3 %; og beholderorgan til at indeholde nævnte første enhedsform; og, b) i en anden enhedsform, et administrationsvehikel omfattende histidin i en koncentration på 1,55 mg/mL egnet til at fastholde pH'en af nævnte sammensætning ved pH 6,0 når opløst i vandigt solvent; og beholderorgan til at indeholde nævnte anden enhedsform.
4. Kit ifølge krav 2, hvilket kit omfatter: a) i en første enhedsform, en sammensætning bestående af 1.0 mg/mL af rekombinant faktor Vlla, 2.34 mg/mL af natriumchlorid, 1,47 mg/mL af calciumchlorid, 2H2O, 1,32 mg/mL af glycylglycin, 0,07 mg/mL af polysorbat 80, 0,5 mg/mL af methionin, 25 mg/mL af mannitol, 10 mg/mL af sukrose, hvor sammensætningen har et fugtindhold på ikke mere end 3 %; og beholderorgan til at indeholde nævnte første enhedsform; og, b) i en anden enhedsform, et administrationsvehikel omfattende histidin i en koncentration på 1,55 mg/mL egnet til at fastholde pH'en af nævnte sammensætning ved pH 6,0 når opløst i vandigt solvent; og beholderorgan til at indeholde nævnte anden enhedsform.
5. Fremgangsmåde til fremstilling af en væskeformulering af rekombinant faktor Vlla, hvilken fremgangsmåde omfatter trinnene: a) at tilvejebringe en første og en anden enhedsform som beskrevet i et hvilket som helst af kravene 1-4; b) at blande nævnte første og anden enhedsformer for således at tilvejebringe en opløst flydende opløsning af sammensætningen i administrationsvehiklet.
6. Kit som defineret i et hvilket som helst af kravene 1-4 til anvendelse i behandling af et FVII-responsivt syndrom, hvor nævnte syndrom er valgt fra gruppen bestående af: erhvervet eller medfødt hæmofili A; erhvervet eller medfødt hæmofili B; Faktor XI-mangel; Faktor Vll-mangel; Glanzmann thrombasteni; thrombocytopeni; von Willebrands sygdom; tilstedeværelse afen koagulationsfaktor-inhibitor, såsom inhibitorer af faktor VIII eller IX; kirurgi; traume; fortyndet koagulationsdefekt; og antikoagulationsterapi.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DKPA200301901 | 2003-12-19 | ||
EP04804925A EP1703899B1 (en) | 2003-12-19 | 2004-12-17 | Stabilised compositions of factor vii polypeptides |
Publications (1)
Publication Number | Publication Date |
---|---|
DK2298287T3 true DK2298287T3 (da) | 2018-07-23 |
Family
ID=34684457
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK10181045.5T DK2298287T3 (da) | 2003-12-19 | 2004-12-17 | Stabiliserede sammensætninger af faktor VII-polypeptider |
Country Status (20)
Country | Link |
---|---|
US (7) | US20070021338A1 (da) |
EP (4) | EP3378470A1 (da) |
JP (2) | JP2007519623A (da) |
KR (4) | KR20140093711A (da) |
CN (1) | CN1917861B (da) |
AT (1) | ATE507822T1 (da) |
AU (1) | AU2004298789A1 (da) |
BR (1) | BRPI0417721B8 (da) |
CA (1) | CA2549593C (da) |
DE (1) | DE602004032573D1 (da) |
DK (1) | DK2298287T3 (da) |
ES (1) | ES2676644T3 (da) |
HU (1) | HUE038162T2 (da) |
MX (1) | MXPA06006886A (da) |
PL (1) | PL2298287T3 (da) |
PT (1) | PT2298287T (da) |
RU (1) | RU2373953C2 (da) |
SI (1) | SI2298287T1 (da) |
TR (1) | TR201809670T4 (da) |
WO (1) | WO2005058283A2 (da) |
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WO2005002615A1 (en) * | 2003-07-01 | 2005-01-13 | Novo Nordisk Health Care Ag | Liquid, aqueous pharmaceutical composition of factor vii polypeptides |
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EP3378470A1 (en) | 2003-12-19 | 2018-09-26 | Novo Nordisk Health Care AG | Stabilised compositions of factor vii polypeptides |
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