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

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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WO2001030373A1 (fr) * 1999-10-28 2001-05-03 Institut Neftekhimicheskogo Sinteza Imeni A.V.To Pchieva Rossiiskoi Akademii Nauk (Inkhs Ran) Composition polypeptidique
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US6887462B2 (en) * 2001-04-09 2005-05-03 Chiron Corporation HSA-free formulations of interferon-beta
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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
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RU2541784C2 (ru) 2006-11-07 2015-02-20 Санофи Пастер Байолоджикс Ко. Лиофилизированная композиция для индукции иммунного ответа на флавивирус, композиция и способ для ее получения
AU2008269086B2 (en) * 2007-06-25 2014-06-12 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
CN102301235B (zh) * 2008-11-28 2014-11-19 Abbvie公司 稳定的抗体组合物和用于稳定其的方法
EP2496246B1 (en) * 2009-11-03 2018-06-27 Grifols Therapeutics LLC Composition, method, and kit for alpha-1 proteinase inhibitor
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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
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US9480739B2 (en) 2013-03-15 2016-11-01 Intervet Inc. Bovine virus vaccines that are liquid stable
AR097762A1 (es) 2013-09-27 2016-04-13 Intervet Int Bv Formulaciones secas de vacunas que son estables a temperatura ambiente
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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
IL113578A (en) 1999-10-28
AU1777495A (en) 1995-11-16
KR950031103A (ko) 1995-12-18
EP0682944B1 (fr) 1999-04-07
EP0682944A1 (fr) 1995-11-22
RU2136306C1 (ru) 1999-09-10
CA2148537A1 (en) 1995-11-05
CN1116522A (zh) 1996-02-14
FI952119A (fi) 1995-11-05
FI952119A0 (fi) 1995-05-03
JP2948125B2 (ja) 1999-09-13
HU9501276D0 (en) 1995-06-28
FR2719479A1 (fr) 1995-11-10
DE69508837T2 (de) 1999-11-04
SI0682944T1 (en) 1999-08-31
DK0682944T3 (da) 1999-10-18
NO320364B1 (no) 2005-11-28
CZ286195B6 (cs) 2000-02-16
HUT72325A (en) 1996-04-29
ATE178484T1 (de) 1999-04-15
ZA953596B (en) 1996-11-04
NO951724D0 (no) 1995-05-03
CA2148537C (en) 2002-07-16
PL308416A1 (en) 1995-11-13
TW397687B (en) 2000-07-11
ES2131781T3 (es) 1999-08-01
KR100273053B1 (ko) 2000-12-01
IL113578A0 (en) 1995-08-31
AU694763B2 (en) 1998-07-30
FI117321B (fi) 2006-09-15
US5763409A (en) 1998-06-09
FR2719479B1 (fr) 1996-07-26
PL179240B1 (pl) 2000-08-31
HU220220B (hu) 2001-11-28
DE69508837D1 (de) 1999-05-12
CN1088583C (zh) 2002-08-07
JPH0853361A (ja) 1996-02-27
GR3030146T3 (en) 1999-08-31
NZ272045A (en) 1996-02-27
NO951724L (no) 1995-11-06
CZ108195A3 (en) 1996-02-14

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