ES2131781T3 - Formulacion estable liofilizada que comprende una proteina, equipo de dosificacion. - Google Patents

Formulacion estable liofilizada que comprende una proteina, equipo de dosificacion.

Info

Publication number
ES2131781T3
ES2131781T3 ES95401012T ES95401012T ES2131781T3 ES 2131781 T3 ES2131781 T3 ES 2131781T3 ES 95401012 T ES95401012 T ES 95401012T ES 95401012 T ES95401012 T ES 95401012T ES 2131781 T3 ES2131781 T3 ES 2131781T3
Authority
ES
Spain
Prior art keywords
protein
stable formulation
dosing equipment
lyophilized stable
lyophilized
Prior art date
Legal status (The legal status 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 status listed.)
Expired - Lifetime
Application number
ES95401012T
Other languages
English (en)
Inventor
Alain Bayol
Thierry Breul
Patrice Dupin
Philippe Faure
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sanofi SA
Original Assignee
Sanofi 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
Application filed by Sanofi SA filed Critical Sanofi SA
Application granted granted Critical
Publication of ES2131781T3 publication Critical patent/ES2131781T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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
    • 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
    • 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
    • A61K47/26—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
    • 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
    • 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
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00—Chemistry: molecular biology and microbiology
    • Y10S435/81—Packaged device or kit

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Immunology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Enzymes And Modification Thereof (AREA)

Abstract

LA INVENCION SE REFIERE A UNA FORMULACION ESTABLE, LIOFILIZADA, FARMACEUTICAMENTE ACEPTABLE QUE COMPRENDE UNA PROTEINA, UN TAMPON, ALANINA Y MANITOL, EN LA QUE LA RELACION R = MASA DE MANITOL/MASA DE ALANINA ESTA COMPRENDIDA ENTRE 0,1 Y 1. LA PROTEINA ES PARTICULARMENTE UNA PROTEINA CON ACTIVIDAD BIOLOGICA TAL COMO UNA HORMONA, EN PARTICULAR LA HGH, UNA ENZIMA O UNA CITOQUINA. LA INVENCION SE REFIERE TAMBIEN A UN KIT DE DOSIFICACION QUE COMPRENDE UNA FORMULACION PRECEDENTEMENTE DEFINIDA.
ES95401012T 1994-05-04 1995-05-02 Formulacion estable liofilizada que comprende una proteina, equipo de dosificacion. Expired - Lifetime ES2131781T3 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
FR9405486A FR2719479B1 (fr) 1994-05-04 1994-05-04 Formulation stable lyophilisée comprenant une protéine: kit de dosage.

Publications (1)

Publication Number Publication Date
ES2131781T3 true ES2131781T3 (es) 1999-08-01

Family

ID=9462880

Family Applications (1)

Application Number Title Priority Date Filing Date
ES95401012T Expired - Lifetime ES2131781T3 (es) 1994-05-04 1995-05-02 Formulacion estable liofilizada que comprende una proteina, equipo de dosificacion.

Country Status (25)

Country Link
US (1) US5763409A (es)
EP (1) EP0682944B1 (es)
JP (1) JP2948125B2 (es)
KR (1) KR100273053B1 (es)
CN (1) CN1088583C (es)
AT (1) ATE178484T1 (es)
AU (1) AU694763B2 (es)
CA (1) CA2148537C (es)
CZ (1) CZ286195B6 (es)
DE (1) DE69508837T2 (es)
DK (1) DK0682944T3 (es)
ES (1) ES2131781T3 (es)
FI (1) FI117321B (es)
FR (1) FR2719479B1 (es)
GR (1) GR3030146T3 (es)
HU (1) HU220220B (es)
IL (1) IL113578A (es)
MX (1) MX9502034A (es)
NO (1) NO320364B1 (es)
NZ (1) NZ272045A (es)
PL (1) PL179240B1 (es)
RU (1) RU2136306C1 (es)
SI (1) SI0682944T1 (es)
TW (1) TW397687B (es)
ZA (1) ZA953596B (es)

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ZA966075B (en) * 1995-07-27 1998-01-19 Genentech Inc Protein formulation.
US6267958B1 (en) 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
DE19539574A1 (de) * 1995-10-25 1997-04-30 Boehringer Mannheim Gmbh Zubereitungen und Verfahren zur Stabilisierung biologischer Materialien mittels Trocknungsverfahren ohne Einfrieren
FR2740686B1 (fr) 1995-11-03 1998-01-16 Sanofi Sa Formulation pharmaceutique lyophilisee stable
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FR2768341B1 (fr) 1997-09-18 2000-04-14 Lab Francais Du Fractionnement Composition pharmaceutique placebo lyophilisable destinee a imiter un medicament, notamment a base de proteines ou de polypeptides
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AU2945199A (en) * 1998-03-18 1999-10-11 Ronai, Peter Amorphous glasses for stabilising sensitive products
CA2634663C (en) * 1999-02-22 2009-08-25 University Of Connecticut Novel albumin-free factor viii formulations
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US6887462B2 (en) * 2001-04-09 2005-05-03 Chiron Corporation HSA-free formulations of interferon-beta
JP2005508220A (ja) * 2001-10-24 2005-03-31 パーリ・ゲーエムベーハー 薬用組成物調製用具
AU2003234382B2 (en) 2002-05-13 2010-07-08 Becton, Dickinson And Company Protease inhibitor sample collection system
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EP1589949B1 (en) * 2003-01-08 2008-08-13 Novartis Vaccines and Diagnostics, Inc. Stabilized lyophilized compositions comprising tissue factor pathway inhibitor or tissue factor pathway inhibitor variants
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AU2004229335C1 (en) * 2003-04-04 2010-06-17 Genentech, Inc. High concentration antibody and protein formulations
DE10333317A1 (de) * 2003-07-22 2005-02-17 Biotecon Therapeutics Gmbh Formulierung für Proteinarzneimittel ohne Zusatz von humanem Serumalbumin (HSA)
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US9078992B2 (en) 2008-10-27 2015-07-14 Pursuit Vascular, Inc. Medical device for applying antimicrobial to proximal end of catheter
EP2385825B1 (en) 2008-11-07 2018-10-10 University of Connecticut Factor viii formulations
MX2011005672A (es) * 2008-11-28 2011-06-20 Abbott Lab Composiciones de anticuerpo estables y metodos para estabilizar a las mismas.
PT2496246T (pt) * 2009-11-03 2018-07-31 Grifols Therapeutics Llc Composição, método e kit para o inibidor da alfa-1 protease
SG181628A1 (en) * 2009-12-22 2012-07-30 Celldex Therapeutics Inc Vaccine compositions
RU2448156C1 (ru) * 2011-03-17 2012-04-20 Эспосито Трейдинг Лтд Способ получения лиофилизированной субстанции
RU2448158C1 (ru) * 2011-03-24 2012-04-20 Эспосито Трейдинг Лтд Способ получения препарата фортелизин, обладающего фибринолитическими свойствами, и его применение для лечения инфаркта миокарда
US10166381B2 (en) 2011-05-23 2019-01-01 Excelsior Medical Corporation Antiseptic cap
ES2797649T3 (es) 2011-07-12 2020-12-03 Icu Medical Inc Dispositivo para entrega de agente antimicrobiano en un catéter transdérmico
EP2760998B1 (en) * 2011-11-22 2017-02-01 Siemens Healthcare Diagnostics Inc. Devices containing dried reagents for reconstitution as calibration and/or quality control solutions, and methods of production and use thereof
US20140017318A1 (en) * 2012-07-10 2014-01-16 Kevin O'Connell Method to produce a medicinal product comprising a biologically active protein and the resulting product
US9314519B2 (en) 2012-08-21 2016-04-19 Intervet Inc. Liquid stable virus vaccines
US9393298B2 (en) 2013-03-15 2016-07-19 Intervet Inc. Liquid stable bovine virus vaccines
US9480739B2 (en) 2013-03-15 2016-11-01 Intervet Inc. Bovine virus vaccines that are liquid stable
BR112016006455A2 (pt) 2013-09-27 2017-08-01 Hanmi Pharm Ind Co Ltd ?formulação de conjugado de hormônio de crescimento humano de ação prolongada?
AR097762A1 (es) 2013-09-27 2016-04-13 Intervet Int Bv Formulaciones secas de vacunas que son estables a temperatura ambiente
AR099470A1 (es) 2014-02-17 2016-07-27 Intervet Int Bv Vacunas de virus de aves de corral líquidas
TWI670085B (zh) 2014-02-19 2019-09-01 荷蘭商英特威國際公司 液體穩定之豬病毒疫苗
AU2015252808B2 (en) 2014-05-02 2019-02-21 Excelsior Medical Corporation Strip package for antiseptic cap
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Also Published As

Publication number Publication date
AU1777495A (en) 1995-11-16
CZ286195B6 (cs) 2000-02-16
HU9501276D0 (en) 1995-06-28
HU220220B (hu) 2001-11-28
RU2136306C1 (ru) 1999-09-10
SI0682944T1 (en) 1999-08-31
FI952119A0 (fi) 1995-05-03
KR100273053B1 (ko) 2000-12-01
CA2148537A1 (en) 1995-11-05
IL113578A (en) 1999-10-28
IL113578A0 (en) 1995-08-31
EP0682944A1 (fr) 1995-11-22
NZ272045A (en) 1996-02-27
CN1116522A (zh) 1996-02-14
NO320364B1 (no) 2005-11-28
KR950031103A (ko) 1995-12-18
NO951724L (no) 1995-11-06
AU694763B2 (en) 1998-07-30
CZ108195A3 (en) 1996-02-14
DE69508837T2 (de) 1999-11-04
CA2148537C (en) 2002-07-16
ATE178484T1 (de) 1999-04-15
US5763409A (en) 1998-06-09
HUT72325A (en) 1996-04-29
PL308416A1 (en) 1995-11-13
FI117321B (fi) 2006-09-15
JP2948125B2 (ja) 1999-09-13
GR3030146T3 (en) 1999-08-31
FI952119L (fi) 1995-11-05
DE69508837D1 (de) 1999-05-12
ZA953596B (en) 1996-11-04
FR2719479A1 (fr) 1995-11-10
PL179240B1 (pl) 2000-08-31
TW397687B (en) 2000-07-11
JPH0853361A (ja) 1996-02-27
DK0682944T3 (da) 1999-10-18
FR2719479B1 (fr) 1996-07-26
NO951724D0 (no) 1995-05-03
MX9502034A (es) 1997-02-28
EP0682944B1 (fr) 1999-04-07
CN1088583C (zh) 2002-08-07

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