CA2151732A1 - Stable lyophilized pharmaceutical preparations of g-csf - Google Patents

Stable lyophilized pharmaceutical preparations of g-csf

Info

Publication number
CA2151732A1
CA2151732A1 CA002151732A CA2151732A CA2151732A1 CA 2151732 A1 CA2151732 A1 CA 2151732A1 CA 002151732 A CA002151732 A CA 002151732A CA 2151732 A CA2151732 A CA 2151732A CA 2151732 A1 CA2151732 A1 CA 2151732A1
Authority
CA
Canada
Prior art keywords
csf
pharmaceutical preparations
lyophilized pharmaceutical
amount
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.)
Granted
Application number
CA002151732A
Other languages
French (fr)
Other versions
CA2151732C (en
Inventor
Gerhard Winter
Heinrich Woog
Rainer Rudolph
Uwe Michaelis
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.)
Amgen Inc
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of CA2151732A1 publication Critical patent/CA2151732A1/en
Application granted granted Critical
Publication of CA2151732C publication Critical patent/CA2151732C/en
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

Abstract

The present invention concerns lyophilized pharmaceutical preparations of G-CSF that contain maltose, cellobiose, gentiobiose, isomaltose, raffinose, sucrose or trehalose as stabilizing agents. In addition, the invention concerns a process for the production of stabilized lyophilisates as well as the use of maltose, cellobiose, gentiobiose, isomaltose, raffinose, sucrose or trehalose as stabilizing agents of pharmaceutical agents containing G-CSF. The preparations also contain a physiologically tolerated amount of a surfactant, in an amount no greater than the amount of G-CSF.
CA002151732A 1992-12-18 1993-12-15 Stable lyophilized pharmaceutical preparations of g-csf Expired - Lifetime CA2151732C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DEP4242863.7 1992-12-18
DE4242863A DE4242863A1 (en) 1992-12-18 1992-12-18 Stable lyophilized pharmaceutical preparations of G-CSF
PCT/EP1993/003543 WO1994014465A1 (en) 1992-12-18 1993-12-15 Stable lyophilized pharmaceutical preparations g-csf

Publications (2)

Publication Number Publication Date
CA2151732A1 true CA2151732A1 (en) 1994-07-07
CA2151732C CA2151732C (en) 2008-02-12

Family

ID=6475691

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002151732A Expired - Lifetime CA2151732C (en) 1992-12-18 1993-12-15 Stable lyophilized pharmaceutical preparations of g-csf

Country Status (14)

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

Families Citing this family (39)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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 (en) * 1995-10-25 1997-04-30 Boehringer Mannheim Gmbh Preparations and processes for stabilizing biological materials by means of drying processes without freezing
US5770700A (en) * 1996-01-25 1998-06-23 Genetics Institute, Inc. Liquid factor IX formulations
EP0852951A1 (en) * 1996-11-19 1998-07-15 Roche Diagnostics GmbH Stable lyophilized monoclonal or polyclonal antibodies containing pharmaceuticals
CN1264569C (en) * 1998-03-06 2006-07-19 中外制药株式会社 Protein-free preparations
WO2000000221A1 (en) * 1998-06-26 2000-01-06 Otsuka Pharmaceutical Co., Ltd. Water soluble dry compositions
CN100553678C (en) * 1999-02-22 2009-10-28 巴克斯特国际有限公司 The factor VIII formulations of new albumin-free
JP2000247903A (en) * 1999-03-01 2000-09-12 Chugai Pharmaceut Co Ltd Long-term stabilized pharmaceutical preparation
EP1254944B1 (en) * 1999-12-24 2007-03-28 Otsuka Pharmaceutical Co., Ltd. Dry compositions containing hydrophobic amino acid
CA2337661A1 (en) 2000-02-29 2001-08-29 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
EP1930024A3 (en) 2000-09-01 2008-08-06 Chugai Seiyaku Kabushiki Kaisha G-CSF solution formulations having long-term stability
US20020150541A1 (en) * 2000-09-12 2002-10-17 Gene Trol Biotherapeutics, Inc. Compositions comprising mixtures of therapeutic proteins and methods of producing the same
US20030129162A1 (en) * 2000-09-12 2003-07-10 Lau Allan S. Compositions comprising mixtures of therapeutic proteins and methods of producing the same
CA2422060A1 (en) * 2000-09-12 2002-03-21 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 (en) * 2001-12-21 2003-07-03 Merck Patent Gmbh Lyophilized preparation containing antibodies to EGF receptor
DE10204792A1 (en) * 2002-02-06 2003-08-14 Merck Patent Gmbh Lyophilized preparation containing immunocytokines
AU2003268664A1 (en) * 2002-09-26 2004-04-19 Shionogi And Co., Ltd. Stabilized protein compositions
FR2857267B1 (en) * 2003-07-09 2006-03-10 Lab Francais Du Fractionnement STABILIZING AND SOLUBILIZING FORMULATION FOR CRYOPRECIPITABLE PROTEINS.
DE10348550A1 (en) * 2003-10-20 2005-06-16 Hexal Biotech Forschungsgmbh Stable aqueous G-CSF-containing compositions
US20050148512A1 (en) * 2003-11-10 2005-07-07 Angiotech International Ag Medical implants and fibrosis-inducing agents
SI21639A (en) * 2003-12-23 2005-06-30 LEK farmacevtska dru�ba d.d. Pharmaceutical preparation containing non-micellar sulphobetains
DE102004022928A1 (en) * 2004-05-10 2005-12-08 Boehringer Ingelheim Pharma Gmbh & Co. Kg Powder containing novel oligosaccharide mixtures and process for their preparation
WO2006046079A1 (en) 2004-10-29 2006-05-04 Pharma Mar S.A., Sociedad Unipersonal Formulations comprising ecteinascidin and a disaccharide
DE102006009437A1 (en) 2006-03-01 2007-09-13 Bioceuticals Arzneimittel Ag G-CSF liquid formulation
MX2008013216A (en) * 2006-04-14 2008-10-27 Mannkind Corp Glucagon-like peptide 1(glp-1) pharmaceutical formulations.
WO2008107908A1 (en) * 2007-03-05 2008-09-12 Cadila Healthcare Limited Compositions comprising peg- interferon alpha conjugates and raffinose as cryoprotectant
KR20090130044A (en) * 2007-04-04 2009-12-17 쎄러테크놀로지스 인코포레이티드 Pharmaceutical formulations of ghrh molecules
DE602008004235D1 (en) * 2007-04-05 2011-02-10 Sandoz Ag STABLE Aqueous G-CSF FORMULATIONS
EP2076243B9 (en) 2007-08-27 2015-01-14 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
JP5779780B2 (en) 2008-11-07 2015-09-16 バクスター・インターナショナル・インコーポレイテッドＢａｘｔｅｒ Ｉｎｔｅｒｎａｔｉｏｎａｌ Ｉｎｃｏｒｐ０Ｒａｔｅｄ Factor VIII formulation
EP2387420A2 (en) 2009-01-16 2011-11-23 Teva Pharmaceutical Industries Limited New stable formulations of recombinant human albumin-human granulocyte colony stimulating factor fusion protein
SG10201908916UA (en) * 2010-04-27 2019-11-28 Scil Tech Gmbh Stable MIA/CD-RAP formulations
AR083006A1 (en) * 2010-09-23 2013-01-23 Lilly Co Eli FORMULATIONS FOR THE STIMULATING FACTOR OF COLONIES OF GRANULOCITS (G-CSF) BOVINE AND VARIANTS OF THE SAME
DK3744319T3 (en) 2019-05-28 2023-01-16 Ilkogen Ilac Sanayi Ve Ticaret A S STABLE LYOPHILIZED FORMULATION FOR HYBRID FC-FUSIONED G-CSF
CN112807281A (en) * 2019-10-31 2021-05-18 南京海维医药科技有限公司 Stable compositions comprising angiotensin II and methods of making and using same

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GR871067B (en) * 1986-07-18 1987-11-19 Chugai Pharmaceutical Co Ltd Process for producing stable pharmaceutical preparation containing granulocyte colony stimulating factor
JP2577744B2 (en) * 1986-07-18 1997-02-05 中外製薬株式会社 Stable granulocyte colony-stimulating factor containing preparation
US5104651A (en) * 1988-12-16 1992-04-14 Amgen Inc. Stabilized hydrophobic protein formulations of g-csf
JP3249147B2 (en) * 1990-06-01 2002-01-21 キリン−アムジエン・インコーポレーテツド Oral preparation containing bioactive protein
US5416071A (en) * 1991-03-12 1995-05-16 Takeda Chemical Industries, Ltd. Water-soluble composition for sustained-release containing epo and hyaluronic acid
DE4126983A1 (en) * 1991-08-15 1993-02-18 Boehringer Mannheim Gmbh METHOD FOR THE PRODUCTION OF HUMAN-PROTEIN-CONTAINING, PRESERVED MEDICAMENTS FOR INFUSION OR INJECTION USE
DE4126984A1 (en) * 1991-08-15 1993-02-18 Boehringer Mannheim Gmbh PROCESS FOR THE MANUFACTURE OF HUMAN PROTEIN-CONTAINING, SUITABLE MEDICAMENTS FOR INFUSION OR INJECTION USE
ATE146359T1 (en) * 1992-01-21 1997-01-15 Stanford Res Inst Int IMPROVED METHOD FOR PRODUCING MICRONIZED POLYPEPTIDE DRUGS
DE4242919A1 (en) * 1992-12-18 1994-06-23 Boehringer Mannheim Gmbh Process for the preparation of storage-stable aqueous pharmaceutical preparations of G-CSF
AU3599995A (en) * 1994-10-04 1996-04-26 Csl Limited Controlled-release pharmaceutical preparations

Also Published As

Publication number Publication date
JPH08504784A (en) 1996-05-21
HUT74269A (en) 1996-11-28
WO1994014465A1 (en) 1994-07-07
KR100266145B1 (en) 2000-09-15
ATE165007T1 (en) 1998-05-15
SG66740A1 (en) 1999-09-21
CA2151732C (en) 2008-02-12
HU220256B (en) 2001-11-28
DK0674524T3 (en) 1999-02-01
US5919443A (en) 1999-07-06
HU9501764D0 (en) 1995-08-28
DE4242863A1 (en) 1994-06-23
EP0674524B1 (en) 1998-04-15
KR950703987A (en) 1995-11-17
EP0674524A1 (en) 1995-10-04
ES2117781T3 (en) 1998-08-16
DE59308415D1 (en) 1998-05-20
AU6808694A (en) 1994-07-19
NZ258912A (en) 1997-06-24
AU676573B2 (en) 1997-03-13

Similar Documents

Publication Publication Date Title
CA2151732A1 (en) Stable lyophilized pharmaceutical preparations of g-csf
AU692430C (en) Aqueous pharmaceutical preparations of G-CSF with a long shelf life
EP1600448A3 (en) Enantiomerically pure beta-D-(-)-Dioxolane-Nucleosides
DK0588539T3 (en) Stabilized pharmaceutical preparations containing derivatives of vitamins D2 and D3
CA2226548A1 (en) Lyophilized hepatocyte growth factor preparations
PL311639A1 (en) Stable gamma interferon composition in liquid form
ZA855793B (en) Alpha-aryl-4-(4,5-dihydro-3,5-dioxo-1,2,4-triazin-2(3h)-yl)benzeneacetonitriles
EP0179430A3 (en) Aqueous pharmaceutical formulations of piroxicam monohydrate
EP0641216A1 (en) Pharmaceutical compositions containing il-6.
HUT47794A (en) Insecticide, acaricide and nematocide compositions containing pyridazinone derivatives as active components and process for producing the active components
HUT47436A (en) Process for stabilizing pharmaceutically active proteines in pharmaceutical compositions
EP0597130A4 (en) Antirheumatic.
AU623386B2 (en) 1-dimethylcarbamoyl-3-substituted-5-substituted-1h-1,2,4- triazoles

Legal Events

Date Code Title Description
EEER Examination request
MKEX Expiry

Effective date: 20131216