AR118012A2 - Una composición farmacéutica estable liofilizada de un factor von willebrand recombinante - Google Patents

Una composición farmacéutica estable liofilizada de un factor von willebrand recombinante

Info

Publication number
AR118012A2
AR118012A2 ARP200100313A ARP200100313A AR118012A2 AR 118012 A2 AR118012 A2 AR 118012A2 AR P200100313 A ARP200100313 A AR P200100313A AR P200100313 A ARP200100313 A AR P200100313A AR 118012 A2 AR118012 A2 AR 118012A2
Authority
AR
Argentina
Prior art keywords
group
pharmaceutical composition
von willebrand
willebrand factor
rvwf
Prior art date
Application number
ARP200100313A
Other languages
English (en)
Original Assignee
Baxalta GmbH
Baxalta Inc
Baxter Healthcare Sa
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=42109151&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR118012(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Baxalta GmbH, Baxalta Inc, Baxter Healthcare Sa filed Critical Baxalta GmbH
Publication of AR118012A2 publication Critical patent/AR118012A2/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36Blood coagulation or fibrinolysis factors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Hematology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)

Abstract

Una composición farmacéutica estable liofilizada de un Factor von Willebrand recombinante (rVWF), que comprende: (a) un rVWF; (b) uno o más agentes amortiguadores; (c) uno o más aminoácidos; (d) uno o más agentes estabilizantes; y (e) uno o más agentes tensioactivos; donde dicho rVWF comprende la secuencia de aminoácidos de la SEQ ID Nº 3; donde dicho agente amortiguador comprende un agente amortiguador del pH seleccionado del grupo que consiste en citrato y HEPES a 15 mM y dicho pH se encuentra en un rango de 2,0 a 12,0; dicho aminoácido se selecciona del grupo que consiste de glicina, lisina, e histidina a una concentración de 1 a 500 mM; dicho agente estabilizante está a una concentración de 0,1 a 1000 mM y se selecciona del grupo que consiste en manitol, lactosa, sorbitol, xilitol, sacarosa, trehalosa, manosa, maltosa, lactosa, glucosa, rafinosa, celobiosa, gentbiobiosa, isomaltosa, arabinosa, glucosamina, fructosa y combinaciones de dichos agentes estabilizantes; y dicho agente tensioactivo está a una concentración de 0,01 g/L a 0,5 g/L se selecciona del grupo que consiste de digitonina, Tritón X-100, Tritón X-114, TWEEN-20, TWEEN-80 y combinaciones de estos agentes tensioactivos.
ARP200100313A 2008-10-21 2020-02-05 Una composición farmacéutica estable liofilizada de un factor von willebrand recombinante AR118012A2 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US10727308P 2008-10-21 2008-10-21

Publications (1)

Publication Number Publication Date
AR118012A2 true AR118012A2 (es) 2021-09-08

Family

ID=42109151

Family Applications (2)

Application Number Title Priority Date Filing Date
ARP090104052A AR074054A1 (es) 2008-10-21 2009-10-21 Formulaciones farmaceuticas de factor de von willebrand recombinante liofilizado
ARP200100313A AR118012A2 (es) 2008-10-21 2020-02-05 Una composición farmacéutica estable liofilizada de un factor von willebrand recombinante

Family Applications Before (1)

Application Number Title Priority Date Filing Date
ARP090104052A AR074054A1 (es) 2008-10-21 2009-10-21 Formulaciones farmaceuticas de factor de von willebrand recombinante liofilizado

Country Status (21)

Country Link
US (4) US20100099603A1 (es)
EP (2) EP2349314B1 (es)
JP (6) JP5781931B2 (es)
KR (2) KR101953494B1 (es)
CN (2) CN102387784B (es)
AR (2) AR074054A1 (es)
AU (1) AU2009307648C1 (es)
BR (1) BRPI0919693A2 (es)
CA (1) CA2740919A1 (es)
CY (1) CY1113869T1 (es)
DK (1) DK2349314T3 (es)
ES (1) ES2409032T3 (es)
HR (1) HRP20130414T1 (es)
MX (1) MX2011004247A (es)
NZ (1) NZ592704A (es)
PL (1) PL2349314T3 (es)
PT (1) PT2349314E (es)
SI (1) SI2349314T1 (es)
SM (1) SMT201300093B (es)
TW (3) TWI508735B (es)
WO (1) WO2010048275A2 (es)

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Also Published As

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TW201509429A (zh) 2015-03-16
JP2012506387A (ja) 2012-03-15
EP2601932A1 (en) 2013-06-12
TWI593421B (zh) 2017-08-01
US20210315979A9 (en) 2021-10-14
CA2740919A1 (en) 2010-04-29
DK2349314T3 (da) 2013-05-27
JP2018199715A (ja) 2018-12-20
JP6425674B2 (ja) 2018-11-21
ES2409032T3 (es) 2013-06-24
US20190142908A1 (en) 2019-05-16
KR101953494B1 (ko) 2019-02-28
WO2010048275A2 (en) 2010-04-29
SMT201300093B (it) 2013-11-08
WO2010048275A3 (en) 2011-09-15
BRPI0919693A2 (pt) 2020-08-11
TWI508735B (zh) 2015-11-21
JP2022037215A (ja) 2022-03-08
AU2009307648B2 (en) 2015-09-24
CN102387784B (zh) 2014-04-02
JP2020143166A (ja) 2020-09-10
US11191813B2 (en) 2021-12-07
JP2016106124A (ja) 2016-06-16
US20130172269A1 (en) 2013-07-04
EP2349314B1 (en) 2013-02-27
US10232022B2 (en) 2019-03-19
US20100099603A1 (en) 2010-04-22
JP5781931B2 (ja) 2015-09-24
KR20110088523A (ko) 2011-08-03
NZ592704A (en) 2013-02-22
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CN103919736A (zh) 2014-07-16
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CY1113869T1 (el) 2016-10-05
KR20170049636A (ko) 2017-05-10
AU2009307648A1 (en) 2010-04-29
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CN102387784A (zh) 2012-03-21
EP2349314A2 (en) 2011-08-03
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US20160129090A1 (en) 2016-05-12
AR074054A1 (es) 2010-12-22
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