DK0674524T3 - Stabile, lyofiliserede, farmaceutiske sammensætninger af G-CSF - Google Patents

Stabile, lyofiliserede, farmaceutiske sammensætninger af G-CSF

Info

Publication number
DK0674524T3
DK0674524T3 DK94902772T DK94902772T DK0674524T3 DK 0674524 T3 DK0674524 T3 DK 0674524T3 DK 94902772 T DK94902772 T DK 94902772T DK 94902772 T DK94902772 T DK 94902772T DK 0674524 T3 DK0674524 T3 DK 0674524T3
Authority
DK
Denmark
Prior art keywords
csf
pct
lyophilized
stable
pharmaceutical compositions
Prior art date
Application number
DK94902772T
Other languages
Danish (da)
English (en)
Inventor
Uwe Michaelis
Rainer Rudolph
Gerhard Winter
Heinrich Woog
Original Assignee
Roche Diagnostics Gmbh
Boehringer Mannheim Gmbh
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 Roche Diagnostics Gmbh, Boehringer Mannheim Gmbh filed Critical Roche Diagnostics Gmbh
Application granted granted Critical
Publication of DK0674524T3 publication Critical patent/DK0674524T3/da

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
    • 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
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/193—Colony stimulating factors [CSF]
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
DK94902772T 1992-12-18 1993-12-15 Stabile, lyofiliserede, farmaceutiske sammensætninger af G-CSF DK0674524T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE4242863A DE4242863A1 (de) 1992-12-18 1992-12-18 Stabile lyophilisierte pharmazeutische Zubereitungen von G-CSF
PCT/EP1993/003543 WO1994014465A1 (fr) 1992-12-18 1993-12-15 Preparations pharmaceutiques de g-csf lyophilisees stables

Publications (1)

Publication Number Publication Date
DK0674524T3 true DK0674524T3 (da) 1999-02-01

Family

ID=6475691

Family Applications (1)

Application Number Title Priority Date Filing Date
DK94902772T DK0674524T3 (da) 1992-12-18 1993-12-15 Stabile, lyofiliserede, farmaceutiske sammensætninger af G-CSF

Country Status (14)

Country Link
US (1) US5919443A (fr)
EP (1) EP0674524B1 (fr)
JP (1) JPH08504784A (fr)
KR (1) KR100266145B1 (fr)
AT (1) ATE165007T1 (fr)
AU (1) AU676573B2 (fr)
CA (1) CA2151732C (fr)
DE (2) DE4242863A1 (fr)
DK (1) DK0674524T3 (fr)
ES (1) ES2117781T3 (fr)
HU (1) HU220256B (fr)
NZ (1) NZ258912A (fr)
SG (1) SG66740A1 (fr)
WO (1) WO1994014465A1 (fr)

Families Citing this family (39)

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CA2180206A1 (fr) * 1995-06-30 1996-12-31 Motoya Ohshika Preparation lyophilisee pour usage pharmaceutique
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
US5770700A (en) * 1996-01-25 1998-06-23 Genetics Institute, Inc. Liquid factor IX formulations
EP0852951A1 (fr) * 1996-11-19 1998-07-15 Roche Diagnostics GmbH Compositions pharmaceutiques stables, lyophilisées d'anticorps monoclonaux ou polyclonaux
JP3895109B2 (ja) * 1998-03-06 2007-03-22 中外製薬株式会社 蛋白非添加製剤
KR100652943B1 (ko) * 1998-06-26 2006-12-01 오츠카 세이야쿠 가부시키가이샤 수용성 건조 조성물
JP5149470B2 (ja) 1999-02-22 2013-02-20 バクスター・インターナショナル・インコーポレイテッド 新規のアルブミンを含有していない第ｖｉｉｉ因子処方物
JP2000247903A (ja) * 1999-03-01 2000-09-12 Chugai Pharmaceut Co Ltd 長期安定化製剤
WO2001048117A1 (fr) * 1999-12-24 2001-07-05 Otsuka Pharmaceutical Co., Ltd. Compositions seches contenant un acide amine hydrophobe
DE60103940T2 (de) 2000-02-29 2005-07-28 Pfizer Products Inc., Groton Stabilisierter Granulozyten-Kolonie-stimulierender Faktor
CA2403962C (fr) * 2000-03-31 2009-12-15 Kirin Beer Kabushiki Kaisha Preparation en poudre pour administration transmuqueuse comprenant un medicament a haut poids moleculaire et presentant une stabilite de conservation amelioree
US7998929B2 (en) * 2000-09-01 2011-08-16 Chugai Seikyaku Kabushiki Kaisha Solution preparations stabilized over long time
US20030129162A1 (en) * 2000-09-12 2003-07-10 Lau Allan S. Compositions comprising mixtures of therapeutic proteins and methods of producing the same
US20020150541A1 (en) * 2000-09-12 2002-10-17 Gene Trol Biotherapeutics, Inc. Compositions comprising mixtures of therapeutic proteins and methods of producing the same
EP1318834A2 (fr) * 2000-09-12 2003-06-18 Genetrol Biotherapeutics, Inc. Compositions de melanges de proteines therapeutiques et leurs procedes de production
US20020141970A1 (en) * 2001-03-05 2002-10-03 Pettit Dean K. Stable aqueous solutions of granulocyte macrophage colony-stimulating factor
DE10163459A1 (de) * 2001-12-21 2003-07-03 Merck Patent Gmbh Lyophilisierte Zubereitung enthaltend Antikörper gegen EGF-Rezeptor
DE10204792A1 (de) * 2002-02-06 2003-08-14 Merck Patent Gmbh Lyophilisierte Zubereitung enthaltend Immuncytokine
JP5057648B2 (ja) * 2002-09-26 2012-10-24 塩野義製薬株式会社 安定化されたタンパク組成物
FR2857267B1 (fr) * 2003-07-09 2006-03-10 Lab Francais Du Fractionnement Formulation stabilisante et solubilisante pour les proteines cryoprecipitables.
DE10348550A1 (de) * 2003-10-20 2005-06-16 Hexal Biotech Forschungsgmbh Stabile wässrige G-CSF-haltige Zusammensetzungen
EP1691852A2 (fr) * 2003-11-10 2006-08-23 Angiotech International AG Implants medicaux et agents inducteurs de fibrose
SI21639A (sl) * 2003-12-23 2005-06-30 LEK farmacevtska dru�ba d.d. Farmacevtski pripravek, ki vsebuje nemicelarne sulfobetaine
DE102004022928A1 (de) * 2004-05-10 2005-12-08 Boehringer Ingelheim Pharma Gmbh & Co. Kg Pulver enthaltend neuartige Oligosacharidgemische und Verfahren zu deren Herstellung
RU2382647C2 (ru) 2004-10-29 2010-02-27 Фарма Мар С.А., Сосьедад Униперсональ Композиции, содержащие эктинэсайдин и дисахарид
DE202006020194U1 (de) 2006-03-01 2007-12-06 Bioceuticals Arzneimittel Ag G-CSF-Flüssigformulierung
JP5415938B2 (ja) * 2006-04-14 2014-02-12 マンカインド コーポレイション グルカゴン様ペプチド１（ｇｌｐ−１）医薬製剤
ES2365832T3 (es) * 2007-03-05 2011-10-11 Cadila Healthcare Limited Composiciones que comprenden conjugados de peg-interferón alfa y rafinosa como crioprotector.
CN101678083A (zh) * 2007-04-04 2010-03-24 瑟瑞技术公司 Ghrh分子的药物制剂
CN101657187B (zh) * 2007-04-05 2012-07-18 桑多斯股份公司 稳定的水性g-csf制剂
AU2008291309B2 (en) 2007-08-27 2013-10-17 Ratiopharm Gmbh Liquid formulation of G-CSF
US20110212127A1 (en) * 2008-09-24 2011-09-01 Stabilitech Ltd. Method for Preserving Polypeptides Using a Sugar and Polyethyleneimine
CA2742328C (fr) 2008-11-07 2019-02-26 Baxter International Inc. Formulation de facteur viii
EA201190079A1 (ru) * 2009-01-16 2013-02-28 Тева Фармасьютикал Индастриз, Лтд. Новые стабильные составы рекомбинантного альбумина человека-гранулоцитарного колониестимулирующего фактора человека
RU2739078C2 (ru) * 2010-04-27 2020-12-21 ЭсСиАйЭл Текнолоджи ГмбХ Стабильные водные композиции белка MIA/CD-RAP
TWI480288B (zh) * 2010-09-23 2015-04-11 Lilly Co Eli 牛顆粒細胞群落刺激因子及其變體之調配物
EP3744319B1 (fr) 2019-05-28 2022-10-19 Ilkogen Ilac Sanayi Ve Ticaret A.S. Formulation lyophilisée stable pour g-csf fusionné fc hybride
CN112807281A (zh) * 2019-10-31 2021-05-18 南京海维医药科技有限公司 包含血管紧张素ii的稳定组合物及其制备方法、使用方法

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Publication number Priority date Publication date Assignee Title
JP2577744B2 (ja) * 1986-07-18 1997-02-05 中外製薬株式会社 安定な顆粒球コロニ−刺激因子含有製剤
GR871067B (en) * 1986-07-18 1987-11-19 Chugai Pharmaceutical Co Ltd Process for producing stable pharmaceutical preparation containing granulocyte colony stimulating factor
US5104651A (en) * 1988-12-16 1992-04-14 Amgen Inc. Stabilized hydrophobic protein formulations of g-csf
JP3249147B2 (ja) * 1990-06-01 2002-01-21 キリン−アムジエン・インコーポレーテツド 生理活性蛋白含有経口製剤
US5416071A (en) * 1991-03-12 1995-05-16 Takeda Chemical Industries, Ltd. Water-soluble composition for sustained-release containing epo and hyaluronic acid
DE4126983A1 (de) * 1991-08-15 1993-02-18 Boehringer Mannheim Gmbh Verfahren zur herstellung von humanprotein-enthaltenden, konservierten arzneimitteln fuer infusions- oder injektionszwecke
DE4126984A1 (de) * 1991-08-15 1993-02-18 Boehringer Mannheim Gmbh Verfahren zur herstellung von humanprotein-enthaltenden, gut vertraeglichen arzneimitteln fuer infusions- oder injektionszwecke
WO1993013752A1 (fr) * 1992-01-21 1993-07-22 Sri International Procede ameliore de preparation de medicaments polypeptides sous forme de poudre
DE4242919A1 (de) * 1992-12-18 1994-06-23 Boehringer Mannheim Gmbh Verfahren zur Herstellung von lagerstabilen wässrigen pharmazeutischen Zubereitungen von G-CSF
AU3599995A (en) * 1994-10-04 1996-04-26 Csl Limited Controlled-release pharmaceutical preparations

Also Published As

Publication number Publication date
ATE165007T1 (de) 1998-05-15
HU9501764D0 (en) 1995-08-28
JPH08504784A (ja) 1996-05-21
EP0674524B1 (fr) 1998-04-15
DE4242863A1 (de) 1994-06-23
KR100266145B1 (ko) 2000-09-15
DE59308415D1 (de) 1998-05-20
HU220256B (hu) 2001-11-28
NZ258912A (en) 1997-06-24
HUT74269A (en) 1996-11-28
EP0674524A1 (fr) 1995-10-04
SG66740A1 (en) 1999-09-21
US5919443A (en) 1999-07-06
WO1994014465A1 (fr) 1994-07-07
CA2151732C (fr) 2008-02-12
CA2151732A1 (fr) 1994-07-07
AU676573B2 (en) 1997-03-13
KR950703987A (ko) 1995-11-17
ES2117781T3 (es) 1998-08-16
AU6808694A (en) 1994-07-19

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