MX9502034A - Formulacion estable, liofilizada, que comprende una proteina y equipo de dosificacion. - Google Patents

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

Info

Publication number
MX9502034A
MX9502034A MX9502034A MX9502034A MX9502034A MX 9502034 A MX9502034 A MX 9502034A MX 9502034 A MX9502034 A MX 9502034A MX 9502034 A MX9502034 A MX 9502034A MX 9502034 A MX9502034 A MX 9502034A
Authority
MX
Mexico
Prior art keywords
protein
stable
lyophilized formulation
dispensing equipment
alanine
Prior art date
Application number
MX9502034A
Other languages
English (en)
Inventor
Alin Bayol
Thierry Breul
Patrice Dupin
Philippe Faure
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
Publication of MX9502034A publication Critical patent/MX9502034A/es

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 tiene por objeto una formulacion estable, liofilizada, farmacéuticamente aceptable, que comprende una proteína, una substancia amortiguadora, de alanina y de manitol, en la cual la relacion R = masa de manitol/masa de alanina está comprendida entre 0.1 y 1. La proteína es principalmente una proteína de actividad biologica tal como una hormona, en particular la hGH, una enzima o una citocina. La invencion tiene igualmente por objeto un conjunto de elementos de dosificacion que comprenden una formulacion definida precedentemente.
MX9502034A 1994-05-04 1995-05-02 Formulacion estable, liofilizada, que comprende una proteina y equipo de dosificacion. MX9502034A (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
MX9502034A true MX9502034A (es) 1997-02-28

Family

ID=9462880

Family Applications (1)

Application Number Title Priority Date Filing Date
MX9502034A MX9502034A (es) 1994-05-04 1995-05-02 Formulacion estable, liofilizada, que comprende una proteina y 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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US6685940B2 (en) 1995-07-27 2004-02-03 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
EP0852951A1 (de) * 1996-11-19 1998-07-15 Roche Diagnostics GmbH Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern
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
EP0913178A1 (en) * 1997-11-03 1999-05-06 Boehringer Mannheim Gmbh Process for the manufacture of dry, amorphous products comprising biologically active material by means of convection drying and products obtainable by the process
EP0913177A1 (de) 1997-11-03 1999-05-06 Roche Diagnostics GmbH Verfahren zur Herstellung trockener, amorpher Produkte enthaltend biologisch aktive Materialien mittels Konvektionstrocknung, insbesondere Sprühtrocknung
AU2945199A (en) * 1998-03-18 1999-10-11 Ronai, Peter Amorphous glasses for stabilising sensitive products
BR0008405B1 (pt) * 1999-02-22 2014-04-22 Baxter Int Composição de fator viii formulada sem a adição de albumina, uso de uma composição de fator viii, e, método de liofilizar uma formulação farmacêutica aquosa
IL149355A0 (en) * 1999-10-28 2002-11-10 Inst Neftechimicheskogo Sintez Polypeptide corporation
US6653062B1 (en) 2000-07-26 2003-11-25 Wisconsin Alumni Research Foundation Preservation and storage medium for biological materials
PT1343518E (pt) * 2000-11-07 2009-08-03 Novartis Vaccines & Diagnostic Composições de interferão estabilizadas
US6887462B2 (en) * 2001-04-09 2005-05-03 Chiron Corporation HSA-free formulations of interferon-beta
WO2003035030A1 (en) * 2001-10-24 2003-05-01 Pari Gmbh Kit for the preparation of a pharmaceutical composition
US7309468B2 (en) 2002-05-13 2007-12-18 Becton, Dickinson And Company Protease inhibitor sample collection system
US6803046B2 (en) * 2002-08-16 2004-10-12 Bracco International B.V. Sincalide formulations
JP2008500942A (ja) * 2003-01-08 2008-01-17 カイロン コーポレイション 組織因子経路インヒビターまたは組織因子経路インヒビター改変体を含有する安定化凍結乾燥組成物
GB0304636D0 (en) * 2003-02-28 2003-04-02 Britannia Pharmaceuticals Ltd Pharmaceutical composition for nasal delivery
DE10333317A1 (de) * 2003-07-22 2005-02-17 Biotecon Therapeutics Gmbh Formulierung für Proteinarzneimittel ohne Zusatz von humanem Serumalbumin (HSA)
GB0404586D0 (en) * 2004-03-01 2004-04-07 Britannia Pharmaceuticals Ltd Improvements in or relating to organic materials
US11229746B2 (en) 2006-06-22 2022-01-25 Excelsior Medical Corporation Antiseptic cap
EP2086581B1 (en) * 2006-11-07 2014-08-13 Sanofi Pasteur Biologics, LLC Stabilization of vaccines by lyophilization
EP2170268A2 (en) * 2007-06-25 2010-04-07 Amgen, Inc. Compositions of specific binding agents to hepatocyte growth factor
GB0715285D0 (en) * 2007-08-06 2007-09-12 Britannia Pharmaceuticals Ltd Improvements in or relating to powdered medicaments for nasal delivery
US9078992B2 (en) 2008-10-27 2015-07-14 Pursuit Vascular, Inc. Medical device for applying antimicrobial to proximal end of catheter
US20100168018A1 (en) 2008-11-07 2010-07-01 Baxter International Inc. Factor viii formulations
US20100172862A1 (en) * 2008-11-28 2010-07-08 Abbott Laboratories Stable antibody compositions and methods of stabilizing same
RU2555332C2 (ru) * 2009-11-03 2015-07-10 Грифольс Терапьютикс Инк. Композиция, способ и набор для альфа-1 ингибитора протеазы
CN107412754A (zh) * 2009-12-22 2017-12-01 塞尔德克斯医疗公司 疫苗组合物
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
WO2013009998A2 (en) 2011-07-12 2013-01-17 Pursuit Vascular, Inc. Device for delivery of antimicrobial agent into trans-dermal catheter
CA2856382C (en) * 2011-11-22 2020-07-14 Siemens Healthcare Diagnostics Inc. Devices containing dried reagents for reconstitution as calibration and/or quality control solutions, and methods of production and use thereof
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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
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Also Published As

Publication number Publication date
TW397687B (en) 2000-07-11
PL308416A1 (en) 1995-11-13
CN1088583C (zh) 2002-08-07
JP2948125B2 (ja) 1999-09-13
ES2131781T3 (es) 1999-08-01
EP0682944B1 (fr) 1999-04-07
DK0682944T3 (da) 1999-10-18
FR2719479B1 (fr) 1996-07-26
NO320364B1 (no) 2005-11-28
FI117321B (fi) 2006-09-15
AU1777495A (en) 1995-11-16
HU220220B (hu) 2001-11-28
FI952119A (fi) 1995-11-05
DE69508837T2 (de) 1999-11-04
DE69508837D1 (de) 1999-05-12
CZ286195B6 (cs) 2000-02-16
SI0682944T1 (en) 1999-08-31
RU2136306C1 (ru) 1999-09-10
CA2148537C (en) 2002-07-16
KR950031103A (ko) 1995-12-18
CZ108195A3 (en) 1996-02-14
PL179240B1 (pl) 2000-08-31
IL113578A (en) 1999-10-28
FR2719479A1 (fr) 1995-11-10
AU694763B2 (en) 1998-07-30
NZ272045A (en) 1996-02-27
ZA953596B (en) 1996-11-04
EP0682944A1 (fr) 1995-11-22
HU9501276D0 (en) 1995-06-28
GR3030146T3 (en) 1999-08-31
JPH0853361A (ja) 1996-02-27
NO951724D0 (no) 1995-05-03
CN1116522A (zh) 1996-02-14
KR100273053B1 (ko) 2000-12-01
HUT72325A (en) 1996-04-29
ATE178484T1 (de) 1999-04-15
IL113578A0 (en) 1995-08-31
FI952119A0 (fi) 1995-05-03
CA2148537A1 (en) 1995-11-05
US5763409A (en) 1998-06-09
NO951724L (no) 1995-11-06

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