ES2117781T3 - Preparaciones farmaceuticas liofilizadas y estables de g-csf. - Google Patents

Preparaciones farmaceuticas liofilizadas y estables de g-csf.

Info

Publication number
ES2117781T3
ES2117781T3 ES94902772T ES94902772T ES2117781T3 ES 2117781 T3 ES2117781 T3 ES 2117781T3 ES 94902772 T ES94902772 T ES 94902772T ES 94902772 T ES94902772 T ES 94902772T ES 2117781 T3 ES2117781 T3 ES 2117781T3
Authority
ES
Spain
Prior art keywords
csf
pharmaceutical preparations
stable pharmaceutical
freeze dry
raffinose
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
ES94902772T
Other languages
English (en)
Inventor
Uwe Michaelis
Rainer Rudolph
Gerhard Winter
Heinrich Woog
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.)
Roche Diagnostics GmbH
Original Assignee
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 Boehringer Mannheim GmbH filed Critical Boehringer Mannheim GmbH
Application granted granted Critical
Publication of ES2117781T3 publication Critical patent/ES2117781T3/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
    • 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)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Biochemistry (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)

Abstract

LA INVENCION SE REFIERE A PREPARACIONES FARMACEUTICAS LIOFILIZADAS DE G-CSF QUE CONTIENE MALTOSA, RAFINOSA, SACAROSA, TREHALOSA O AZUCAR AMINO COMO ESTABILIZADORES. ADICIONALMENTE LA INVENCION SE REFIERE A UN METODO PARA LA PREPARACION DE TALES LIOFILIZADOS ESTABILIZADOS Y LA UTILIZACION DE MALTOSA, RAFINOSA, SACAROSA, TREHALOSA O AZUCAR AMINO COMO ESTABILIZADORES DE MEDICAMENTOS CONTENIENDO G-CSF.
ES94902772T 1992-12-18 1993-12-15 Preparaciones farmaceuticas liofilizadas y estables de g-csf. Expired - Lifetime ES2117781T3 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE4242863A DE4242863A1 (de) 1992-12-18 1992-12-18 Stabile lyophilisierte pharmazeutische Zubereitungen von G-CSF

Publications (1)

Publication Number Publication Date
ES2117781T3 true ES2117781T3 (es) 1998-08-16

Family

ID=6475691

Family Applications (1)

Application Number Title Priority Date Filing Date
ES94902772T Expired - Lifetime ES2117781T3 (es) 1992-12-18 1993-12-15 Preparaciones farmaceuticas liofilizadas y estables de g-csf.

Country Status (14)

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

Families Citing this family (41)

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GB9508691D0 (en) * 1995-04-28 1995-06-14 Pafra Ltd Stable compositions
EP0750913A3 (en) * 1995-06-30 1997-11-05 Takeda Chemical Industries, Ltd. Disaccharide containing freeze-dried preparation for pharmaceutical use
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 (de) * 1996-11-19 1998-07-15 Roche Diagnostics GmbH Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern
WO1999044630A1 (en) * 1998-03-06 1999-09-10 Chugai Seiyaku Kabushiki Kaisha Protein-free preparations
ID24279A (id) * 1998-06-26 2000-07-13 Otsuka Pharma Co Ltd Komposisi kering yang terlarut dalam air
DK1820516T3 (da) 1999-02-22 2013-10-28 Univ Connecticut Nye albuminfrie faktor VIII-præparater
JP2000247903A (ja) * 1999-03-01 2000-09-12 Chugai Pharmaceut Co Ltd 長期安定化製剤
KR100709792B1 (ko) * 1999-12-24 2007-04-19 오츠카 세이야쿠 가부시키가이샤 소수성 아미노산을 포함하는 건조 조성물
EP1129720B1 (en) 2000-02-29 2004-06-23 Pfizer Products Inc. Stabilized granulocyte colony stimulating factor
US7282219B2 (en) * 2000-03-31 2007-10-16 Kirin Beer Kabushiki Kaisha Powdery preparation for transmucosal administration containing a polymeric form of drug and exhibiting improved storage stability
KR20030027077A (ko) 2000-09-01 2003-04-03 쥬가이 세이야쿠 가부시키가이샤 장기 안정화 용액 제제
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 (en) * 2000-09-12 2003-06-18 Genetrol Biotherapeutics, Inc. Compositions comprising mixtures of human cytokines and methods of producing the same
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
WO2004028557A1 (ja) * 2002-09-26 2004-04-08 Shionogi & Co., Ltd. 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
WO2005065079A2 (en) * 2003-11-10 2005-07-21 Angiotech International Ag Medical implants and fibrosis-inducing agents
SI21639A (sl) * 2003-12-23 2005-06-30 LEK farmacevtska dru�ba d.d. Farmacevtski pripravek, ki vsebuje nemicelarne sulfobetaine
RU2283646C2 (ru) * 2004-04-27 2006-09-20 Федеральное государственное унитарное предприятие "Научно-производственное объединение по медицинским иммунобиологическим препаратам "Микроген" Министерства здравоохранения Российской Федерации Раствор простакор для инъекций
DE102004022928A1 (de) * 2004-05-10 2005-12-08 Boehringer Ingelheim Pharma Gmbh & Co. Kg Pulver enthaltend neuartige Oligosacharidgemische und Verfahren zu deren Herstellung
ATE368461T1 (de) 2004-10-29 2007-08-15 Pharma Mar Sa Zusammensetzungen enthaltend ecteinascidin und einen disaccharide
DE202006020194U1 (de) 2006-03-01 2007-12-06 Bioceuticals Arzneimittel Ag G-CSF-Flüssigformulierung
KR101438839B1 (ko) * 2006-04-14 2014-10-02 맨카인드 코포레이션 글루카곤 유사 펩타이드 1 （ｇｌｐ-1） 약제학적 제제
BRPI0808259A2 (pt) * 2007-03-05 2014-07-08 Cadila Healthcare Ltd. , "formulação, processo de liofilização, formulação liofilizada, e processo para preparar uma formulação liofilizada"
CN101678083A (zh) * 2007-04-04 2010-03-24 瑟瑞技术公司 Ghrh分子的药物制剂
PL2142174T3 (pl) * 2007-04-05 2011-08-31 Sandoz Ag Stabilne wodne preparaty G-CSF
MX2010002348A (es) * 2007-08-27 2010-07-30 Biogenerix Ag Formulacion liquida de g-csf.
US20110212127A1 (en) * 2008-09-24 2011-09-01 Stabilitech Ltd. Method for Preserving Polypeptides Using a Sugar and Polyethyleneimine
MX339060B (es) 2008-11-07 2016-05-09 Baxter Int Formulaciones del factor viii.
CN102378635A (zh) 2009-01-16 2012-03-14 特瓦制药工业有限公司 重组人白蛋白-人粒细胞集落刺激因子融合蛋白的新稳定制剂
SG10201502398RA (en) * 2010-04-27 2015-05-28 Scil Technology Gmbh Stable MIA/CD-RAP formulations
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
DK3744319T3 (da) 2019-05-28 2023-01-16 Ilkogen Ilac Sanayi Ve Ticaret A S Stabil lyofiliseret formulering til hybrid fc-fusioneret g-csf
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

Family Cites Families (10)

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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
DE4126984A1 (de) * 1991-08-15 1993-02-18 Boehringer Mannheim Gmbh Verfahren zur herstellung von humanprotein-enthaltenden, gut vertraeglichen arzneimitteln fuer infusions- oder injektionszwecke
DE4126983A1 (de) * 1991-08-15 1993-02-18 Boehringer Mannheim Gmbh Verfahren zur herstellung von humanprotein-enthaltenden, konservierten arzneimitteln fuer infusions- oder injektionszwecke
ATE146359T1 (de) * 1992-01-21 1997-01-15 Stanford Res Inst Int Verbessertes verfahren zur herstellung von mikronisierter polypeptidarzneimitteln
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
SG66740A1 (en) 1999-09-21
DE4242863A1 (de) 1994-06-23
ATE165007T1 (de) 1998-05-15
JPH08504784A (ja) 1996-05-21
AU6808694A (en) 1994-07-19
CA2151732C (en) 2008-02-12
HU220256B (hu) 2001-11-28
KR100266145B1 (ko) 2000-09-15
KR950703987A (ko) 1995-11-17
US5919443A (en) 1999-07-06
HU9501764D0 (en) 1995-08-28
DE59308415D1 (de) 1998-05-20
NZ258912A (en) 1997-06-24
WO1994014465A1 (de) 1994-07-07
AU676573B2 (en) 1997-03-13
CA2151732A1 (en) 1994-07-07
EP0674524A1 (de) 1995-10-04
EP0674524B1 (de) 1998-04-15
HUT74269A (en) 1996-11-28
DK0674524T3 (da) 1999-02-01

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