ATE553747T1 - Stabile wässrige lösung von human-erythropoietin, die kein serumalbumin enthält - Google Patents

Stabile wässrige lösung von human-erythropoietin, die kein serumalbumin enthält

Info

Publication number
ATE553747T1
ATE553747T1 AT04773889T AT04773889T ATE553747T1 AT E553747 T1 ATE553747 T1 AT E553747T1 AT 04773889 T AT04773889 T AT 04773889T AT 04773889 T AT04773889 T AT 04773889T AT E553747 T1 ATE553747 T1 AT E553747T1
Authority
AT
Austria
Prior art keywords
human erythropoietin
aqueous solution
stable aqueous
contain serum
serum albumine
Prior art date
Application number
AT04773889T
Other languages
English (en)
Inventor
Kyu Chan Kwon
Suk Young Choi
Young Cheol Kang
Hoon Sung Jeh
Seung Joo Lee
Myung Jin Kim
Ji Eon Kim
Jin-Seok Oh
Original Assignee
Lg Life Sciences Ltd
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=36337525&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ATE553747(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Lg Life Sciences Ltd filed Critical Lg Life Sciences Ltd
Application granted granted Critical
Publication of ATE553747T1 publication Critical patent/ATE553747T1/de

Links

Classifications

    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • 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
    • 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
    • A61K38/18—Growth factors; Growth regulators
    • A61K38/1816—Erythropoietin [EPO]
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06—Antianaemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Inorganic Chemistry (AREA)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Zoology (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
AT04773889T 2003-06-10 2004-06-07 Stabile wässrige lösung von human-erythropoietin, die kein serumalbumin enthält ATE553747T1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR20030037060 2003-06-10
PCT/KR2004/001358 WO2004108152A1 (en) 2003-06-10 2004-06-07 Stable, aqueous solution of human erythropoietin, not containing serum albumin

Publications (1)

Publication Number Publication Date
ATE553747T1 true ATE553747T1 (de) 2012-05-15

Family

ID=36337525

Family Applications (1)

Application Number Title Priority Date Filing Date
AT04773889T ATE553747T1 (de) 2003-06-10 2004-06-07 Stabile wässrige lösung von human-erythropoietin, die kein serumalbumin enthält

Country Status (18)

Country Link
US (1) US8119595B2 (de)
EP (1) EP1641486B1 (de)
JP (1) JP4871720B2 (de)
KR (1) KR100610003B1 (de)
CN (1) CN1802171B (de)
AT (1) ATE553747T1 (de)
AU (1) AU2004244920B2 (de)
BR (1) BRPI0411114B8 (de)
CA (1) CA2528988C (de)
EA (1) EA009676B1 (de)
ES (1) ES2385888T3 (de)
MX (1) MXPA05013398A (de)
NO (1) NO20055747L (de)
NZ (1) NZ543859A (de)
PL (1) PL379272A1 (de)
UA (1) UA82241C2 (de)
WO (1) WO2004108152A1 (de)
ZA (1) ZA200509222B (de)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MY139088A (en) * 2005-02-21 2009-08-28 Lg Life Sciences Ltd Sustained release composition of protein drug
EP1997505A4 (de) 2006-03-22 2013-02-13 Chugai Pharmaceutical Co Ltd Zubereitung einer erythropoetinlösung
DE102007050165B4 (de) * 2007-10-19 2010-06-17 Stiftung Tierärztliche Hochschule Hannover Stabilisierte Lösung, Verfahren zu deren Herstellung sowie deren Verwendung und Arzneimittel in Form einer stabilisierten Lösung
EP3381445B1 (de) 2007-11-15 2023-10-25 Amgen Inc. Wässrige antikörperformulierung mit stabilisierung durch antioxidantien zur parenteralen verabreichung
US20120213846A1 (en) * 2008-08-15 2012-08-23 Forest Laboratories Holdings Limited Stable Solid Formulation of a GC-C Receptor Agonist Polypeptide Suitable for Oral Administration
US8748573B2 (en) * 2009-08-06 2014-06-10 Ironwood Pharmaceuticals, Inc. Formulations comprising linaclotide
US8829163B2 (en) * 2010-01-19 2014-09-09 Hanmi Science Co., Ltd Liquid formulations for long-acting erythropoietin conjugate
WO2011103311A2 (en) 2010-02-17 2011-08-25 Ironwood Pharmaceuticals, Inc Treatments for gastrointestinal disorders
HRP20192207T1 (hr) 2010-08-11 2020-02-21 Ironwood Pharmaceuticals, Inc. Stabilne formulacije linaklotida
KR101303388B1 (ko) 2010-10-26 2013-09-03 한미사이언스 주식회사 지속형 인터페론 알파 결합체의 액상 제제
HUE032237T2 (en) 2011-08-17 2017-09-28 Ironwood Pharmaceuticals Inc Treatments for gastrointestinal disorders
CN107693781B (zh) * 2013-03-13 2021-11-09 巴扎德制药公司 用于眼部递送的嵌合细胞因子制剂
EP2832361A1 (de) * 2013-07-29 2015-02-04 Ipsen Pharma S.A.S. Wässrige Zusammensetzungen mit verzögerter Freisetzung von LHRH-Analoga
US20180110833A1 (en) * 2015-04-21 2018-04-26 Staidson (Beijing) Biopharmaceuticals Co., Ltd. Nerve growth factor composition and powder injection
CN118338910A (zh) * 2021-12-03 2024-07-12 杰科（天津）生物医药有限公司 一种制剂及其制备方法和应用

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NZ210501A (en) 1983-12-13 1991-08-27 Kirin Amgen Inc Erythropoietin produced by procaryotic or eucaryotic expression of an exogenous dna sequence
JPS6191131A (ja) * 1984-10-09 1986-05-09 Chugai Pharmaceut Co Ltd 医薬品の吸着防止方法および組成物
JPS6197229A (ja) * 1984-10-18 1986-05-15 Chugai Pharmaceut Co Ltd 安定なエリトロポエチン製剤
DE3729863A1 (de) * 1987-09-05 1989-03-16 Boehringer Mannheim Gmbh Stabilisierte erythropoietin-lyophilisate
GB9001987D0 (en) * 1990-01-29 1990-03-28 Janssen Pharmaceutica Nv Improved cyclodextrin based erythropietin formulation
DE4126983A1 (de) * 1991-08-15 1993-02-18 Boehringer Mannheim Gmbh Verfahren zur herstellung von humanprotein-enthaltenden, konservierten arzneimitteln fuer infusions- oder injektionszwecke
US5661125A (en) * 1992-08-06 1997-08-26 Amgen, Inc. Stable and preserved erythropoietin compositions
TW518219B (en) * 1996-04-26 2003-01-21 Chugai Pharmaceutical Co Ltd Erythropoietin solution preparation
CA2319680C (en) * 1997-02-07 2010-04-20 Emisphere Technologies, Inc. Compounds and compositions for delivering active agents
TW570805B (en) * 1998-09-01 2004-01-11 Hoffmann La Roche Water-soluble pharmaceutical composition in an ionic complex
AU5649299A (en) * 1998-09-11 2000-04-03 Chugai Seiyaku Kabushiki Kaisha Protein solution preparation and method for stabilizing the same
ATE401908T1 (de) * 1999-04-09 2008-08-15 Ortho Mcneil Pharm Inc Pharmazeutische zusammensetzungen von erythropoietin
EP1232753B1 (de) * 1999-09-08 2008-03-19 Chugai Seiyaku Kabushiki Kaisha Stabile proteinlösung abgefüllt in einem behältnis aus hydrophobem harz und eine methode zur stabilisierung derselben
AU2001236005A1 (en) * 2000-02-29 2001-09-12 Chugai Seiyaku Kabushiki Kaisha Preparations stabilized over long time
JP3967594B2 (ja) * 2000-05-15 2007-08-29 エフ．ホフマン−ラ ロシュ アーゲー 新しい薬剤組成物
SI21258A (sl) * 2002-07-17 2004-02-29 LEK farmacevtska dru�ba d.d. Stabilni farmacevtski pripravek, ki vsebuje eritropoietin in poloksamerni poliol

Also Published As

Publication number Publication date
AU2004244920B2 (en) 2009-07-23
BRPI0411114B1 (pt) 2020-09-15
CA2528988C (en) 2012-05-01
JP4871720B2 (ja) 2012-02-08
WO2004108152A1 (en) 2004-12-16
US20070293419A1 (en) 2007-12-20
NO20055747L (no) 2006-03-07
NO20055747D0 (no) 2005-12-05
CN1802171B (zh) 2010-10-13
KR100610003B1 (ko) 2006-08-08
EA009676B1 (ru) 2008-02-28
NZ543859A (en) 2008-01-31
EP1641486A4 (de) 2008-10-08
HK1093012A1 (en) 2007-02-23
US8119595B2 (en) 2012-02-21
ES2385888T3 (es) 2012-08-02
UA82241C2 (uk) 2008-03-25
CA2528988A1 (en) 2004-12-16
BRPI0411114B8 (pt) 2021-05-25
BRPI0411114A (pt) 2006-07-18
EP1641486A1 (de) 2006-04-05
EP1641486B1 (de) 2012-04-18
EA200501789A1 (ru) 2006-06-30
MXPA05013398A (es) 2006-03-09
PL379272A1 (pl) 2006-08-21
JP2007528842A (ja) 2007-10-18
AU2004244920A1 (en) 2004-12-16
ZA200509222B (en) 2006-09-27
KR20040110994A (ko) 2004-12-31
CN1802171A (zh) 2006-07-12

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