BRPI0408439A - composição farmacêutica lìquida aquosa, método para preparar e uso da mesma, método para tratar uma sìndrome responsiva ao fator vii, e, recipiente hermético - Google Patents

composição farmacêutica lìquida aquosa, método para preparar e uso da mesma, método para tratar uma sìndrome responsiva ao fator vii, e, recipiente hermético

Info

Publication number
BRPI0408439A
BRPI0408439A BRPI0408439-0A BRPI0408439A BRPI0408439A BR PI0408439 A BRPI0408439 A BR PI0408439A BR PI0408439 A BRPI0408439 A BR PI0408439A BR PI0408439 A BRPI0408439 A BR PI0408439A
Authority
BR
Brazil
Prior art keywords
factor
treating
pharmaceutical composition
liquid pharmaceutical
factor vii
Prior art date
Application number
BRPI0408439-0A
Other languages
English (en)
Inventor
Michael Bech Jensen
Birthe Lykkegaard Hansen
Troels Kornfelt
Kirsten Kramer Jakobsen
Janus Krarup
Egon Persson
Anders Klarskov Petersen
Andrew Neil Bowler
Original Assignee
Novo Nordisk Healthcare Ag
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Novo Nordisk Healthcare Ag filed Critical Novo Nordisk Healthcare Ag
Publication of BRPI0408439A publication Critical patent/BRPI0408439A/pt

Links

Classifications

    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • 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
    • A61K47/16—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
    • A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
    • 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
    • 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)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Inorganic Chemistry (AREA)
  • Hematology (AREA)
  • Dermatology (AREA)
  • Diabetes (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Zoology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Wrappers (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

"COMPOSIçãO FARMACêUTICA LìQUIDA AQUOSA, MéTODO PARA PREPARAR E USO DA MESMA, MéTODO PARA TRATAR UMA SìNDROME RESPONSIVA AO FATOR VII, E, RECIPIENTE HERMéTICO". A invenção diz respeito a uma composição farmacêutica líquida aquosa que compreende um polipeptídeo do Fator VII (por exemplo, Fator VIIa de humano) e agente de tamponamento; em que a razão molar de íons cálcio não complexados (Ca¬ 2+¬) para o polipeptídeo do Fator VII é inferior a 0,5. A composição pode ainda compreender um agente de estabilização (por exemplo, íons cobre ou magnésio, benzamidina ou guanidina), um tensoativo não iónico, um agente modificador de tonicidade, um antioxidante e um conservante. A composição é útil para tratar uma síndrome responsiva ao Fator VII, tal como distúrbios de hemorragia, incluindo aqueles causados pelas deficiências do Fator de coagulação (por exemplo, hemofilia A, hemofilia B, deficiência do Fator XI de coagulação, deficiência do Fator VII de coagulação); pela trombocitopenia ou doença de von Willebrand ou pelos inibidores do fator de coagulação e hemorragia intracerebral ou hemorragia excessiva de qualquer causa. As preparações também podem ser administradas aos pacientes em associação com cirurgia ou outro trauma ou aos pacientes que recebam terapia anticoagulante.
BRPI0408439-0A 2003-03-18 2004-03-18 composição farmacêutica lìquida aquosa, método para preparar e uso da mesma, método para tratar uma sìndrome responsiva ao fator vii, e, recipiente hermético BRPI0408439A (pt)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
DKPA200300413 2003-03-18
DKPA200300788 2003-05-23
DKPA200300959 2003-06-25
DKPA200300995 2003-07-01
DKPA200301161 2003-08-14
PCT/DK2004/000181 WO2004082708A2 (en) 2003-03-18 2004-03-18 Liquid, aqueous, pharmaceutical compositions of factor vii polypeptides

Publications (1)

Publication Number Publication Date
BRPI0408439A true BRPI0408439A (pt) 2006-04-04

Family

ID=36074830

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0408439-0A BRPI0408439A (pt) 2003-03-18 2004-03-18 composição farmacêutica lìquida aquosa, método para preparar e uso da mesma, método para tratar uma sìndrome responsiva ao fator vii, e, recipiente hermético

Country Status (10)

Country Link
US (1) US20060063714A1 (pt)
EP (1) EP1605968A2 (pt)
JP (1) JP2006524195A (pt)
KR (1) KR20050110682A (pt)
AU (1) AU2004222625A1 (pt)
BR (1) BRPI0408439A (pt)
CA (1) CA2518327A1 (pt)
MX (1) MXPA05009914A (pt)
RU (1) RU2005132164A (pt)
WO (1) WO2004082708A2 (pt)

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RU2357751C2 (ru) 2001-12-21 2009-06-10 Ново Нордиск Хелт Кэр Аг Жидкая композиция полипептидов фактора vii
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BRPI0311959B8 (pt) 2002-06-21 2021-05-25 Novo Nordisk Healthcare Ag composição, métodos para preparar um polipeptídeo estável do fator vii, e para tratar uma síndrome responsiva do fator vii, e, uso do polipeptídeo do fator vii
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Also Published As

Publication number Publication date
RU2005132164A (ru) 2006-06-10
AU2004222625A1 (en) 2004-09-30
WO2004082708A3 (en) 2005-03-17
MXPA05009914A (es) 2006-01-09
US20060063714A1 (en) 2006-03-23
JP2006524195A (ja) 2006-10-26
EP1605968A2 (en) 2005-12-21
KR20050110682A (ko) 2005-11-23
CA2518327A1 (en) 2004-09-30
WO2004082708A2 (en) 2004-09-30

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