BRPI0413518A - 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
BRPI0413518A
BRPI0413518A BRPI0413518-0A BRPI0413518A BRPI0413518A BR PI0413518 A BRPI0413518 A BR PI0413518A BR PI0413518 A BRPI0413518 A BR PI0413518A BR PI0413518 A BRPI0413518 A BR PI0413518A
Authority
BR
Brazil
Prior art keywords
liquid pharmaceutical
preparing
pharmaceutical composition
aqueous liquid
treating
Prior art date
Application number
BRPI0413518-0A
Other languages
English (en)
Inventor
Michael Bech Jensen
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
Priority claimed from PCT/DK2004/000181 external-priority patent/WO2004082708A2/en
Application filed by Novo Nordisk Healthcare Ag filed Critical Novo Nordisk Healthcare Ag
Publication of BRPI0413518A publication Critical patent/BRPI0413518A/pt

Links

Classifications

    • 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
    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/17—Amides, e.g. hydroxamic acids having the group >N—C(O)—N< or >N—C(S)—N<, e.g. urea, thiourea, carmustine
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents

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 presente invenção está direcionada às composições farmacêuticas líquidas aquosas estabilizadas contra a degradação química e/ou física contendo polipeptídeos do Fator VII e métodos para preparar e usar tais composições, assim como frascos contendo tais composições e o uso de tais composições no tratamento de uma síndrome responsiva ao Fator VII. A forma de realização principal é representada por uma composição farmacêutica líquida aquosa que compreende pelo menos 0,01 mg/ml de um polipeptídeo do Fator VII (i); um agente de tamponamento (ii) adequado para manter o pH na faixa de cerca de 4,0 a cerca de 9,0; e pelo menos um agente de estabilização (iii) que compreende um motivo C(=N Z¬ 1¬ R¬ 1¬) NH Z¬ 2¬ R¬ 2¬, por exemplo, compostos de benzamidina e compostos de guanidina tais como arginina.
BRPI0413518-0A 2003-08-14 2004-08-12 composição farmacêutica lìquida aquosa, método para preparar e uso da mesma, método para tratar uma sìndrome responsiva ao fator vii, e, recipiente hermético BRPI0413518A (pt)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
DKPA200301161 2003-08-14
US49644303P 2003-08-20 2003-08-20
PCT/DK2004/000181 WO2004082708A2 (en) 2003-03-18 2004-03-18 Liquid, aqueous, pharmaceutical compositions of factor vii polypeptides
PCT/DK2004/000537 WO2005016365A2 (en) 2003-08-14 2004-08-12 Liquid, aqueous pharmaceutical composition of factor vii polypeptides

Publications (1)

Publication Number Publication Date
BRPI0413518A true BRPI0413518A (pt) 2006-10-10

Family

ID=36971817

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0413518-0A BRPI0413518A (pt) 2003-08-14 2004-08-12 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 (15)

Country Link
US (4) US7732405B2 (pt)
EP (1) EP1656158B1 (pt)
JP (2) JP5653572B2 (pt)
KR (2) KR20120104619A (pt)
CN (2) CN102872451A (pt)
AU (1) AU2004264282B2 (pt)
BR (1) BRPI0413518A (pt)
CA (1) CA2534028A1 (pt)
ES (1) ES2574581T3 (pt)
IL (1) IL173332A0 (pt)
MX (1) MXPA06001698A (pt)
NO (1) NO20061185L (pt)
RU (1) RU2388460C2 (pt)
WO (1) WO2005016365A2 (pt)
ZA (1) ZA200601250B (pt)

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EP1656158B1 (en) 2016-03-09
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ZA200601250B (en) 2007-04-25
AU2004264282A1 (en) 2005-02-24
RU2388460C2 (ru) 2010-05-10
US20130084274A1 (en) 2013-04-04
IL173332A0 (en) 2006-06-11
US20100056453A1 (en) 2010-03-04
WO2005016365A3 (en) 2005-04-21
US8026214B2 (en) 2011-09-27
ES2574581T3 (es) 2016-06-20
RU2006103281A (ru) 2006-08-10
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CA2534028A1 (en) 2005-02-24
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US20060205648A1 (en) 2006-09-14
EP1656158A2 (en) 2006-05-17
MXPA06001698A (es) 2006-05-19
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JP2007502252A (ja) 2007-02-08
NO20061185L (no) 2006-03-14
US8318904B2 (en) 2012-11-27
KR20060061829A (ko) 2006-06-08
CN102872451A (zh) 2013-01-16
US7732405B2 (en) 2010-06-08
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US20120003206A1 (en) 2012-01-05
CN1845753A (zh) 2006-10-11

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