EA200501789A1 - Стабильный водный раствор эритропоэтина человека, не содержащий сывороточного альбумина - Google Patents

Стабильный водный раствор эритропоэтина человека, не содержащий сывороточного альбумина

Info

Publication number
EA200501789A1
EA200501789A1 EA200501789A EA200501789A EA200501789A1 EA 200501789 A1 EA200501789 A1 EA 200501789A1 EA 200501789 A EA200501789 A EA 200501789A EA 200501789 A EA200501789 A EA 200501789A EA 200501789 A1 EA200501789 A1 EA 200501789A1
Authority
EA
Eurasian Patent Office
Prior art keywords
human erythropoietin
serum albumin
aqueous solution
stable aqueous
containing serum
Prior art date
Application number
EA200501789A
Other languages
English (en)
Other versions
EA009676B1 (ru
Inventor
Киу Чан Квон
Сук Янг Чой
Янг Чеол Канг
Хоон Сунг Дзех
Сеунг Дзоо Ли
Миунг Дзин Ким
Дзи Еон Ким
Дзин-Сеок Ох
Original Assignee
Эл Джи Лайф Сайенсиз Лтд.
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=EA200501789(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Эл Джи Лайф Сайенсиз Лтд. filed Critical Эл Джи Лайф Сайенсиз Лтд.
Publication of EA200501789A1 publication Critical patent/EA200501789A1/ru
Publication of EA009676B1 publication Critical patent/EA009676B1/ru

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)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Inorganic Chemistry (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Zoology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Настоящее изобретение относится к водному препарату эритропоэтина человека, имеющему стабильность при хранении в течение продолжительного периода времени, без сывороточного альбумина, в котором препарат содержит фармацевтически эффективное количество эритропоэтина человека; неионное поверхностно-активное вещество, многоатомный спирт, нейтральную аминокислоту и сахарный спирт в качестве стабилизаторов; изотонический реагент и буферный реагент.
EA200501789A 2003-06-10 2004-06-07 Водный препарат эритропоэтина человека EA009676B1 (ru)

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 (2)

Publication Number Publication Date
EA200501789A1 true EA200501789A1 (ru) 2006-06-30
EA009676B1 EA009676B1 (ru) 2008-02-28

Family

ID=36337525

Family Applications (1)

Application Number Title Priority Date Filing Date
EA200501789A EA009676B1 (ru) 2003-06-10 2004-06-07 Водный препарат эритропоэтина человека

Country Status (19)

Country Link
US (1) US8119595B2 (ru)
EP (1) EP1641486B1 (ru)
JP (1) JP4871720B2 (ru)
KR (1) KR100610003B1 (ru)
CN (1) CN1802171B (ru)
AT (1) ATE553747T1 (ru)
AU (1) AU2004244920B2 (ru)
BR (1) BRPI0411114B8 (ru)
CA (1) CA2528988C (ru)
EA (1) EA009676B1 (ru)
ES (1) ES2385888T3 (ru)
HK (1) HK1093012A1 (ru)
MX (1) MXPA05013398A (ru)
NO (1) NO20055747L (ru)
NZ (1) NZ543859A (ru)
PL (1) PL379272A1 (ru)
UA (1) UA82241C2 (ru)
WO (1) WO2004108152A1 (ru)
ZA (1) ZA200509222B (ru)

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
WO2007108505A1 (ja) * 2006-03-22 2007-09-27 Chugai Seiyaku Kabushiki Kaisha エリスロポエチン溶液製剤
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 (en) * 2007-11-15 2023-10-25 Amgen Inc. Aqueous formulation of antibody stablised by antioxidants for parenteral administration
HUE049023T2 (hu) * 2008-08-15 2020-08-28 Ironwood Pharmaceuticals Inc Linaklotidot tartalmazó, szájon át történõ beadásra szolgáló készítmények
WO2011017502A2 (en) * 2009-08-06 2011-02-10 Ironwood Pharmaceuticals, Inc. Linaclotide-containing formulations for oral administration
WO2011090306A2 (en) * 2010-01-19 2011-07-28 Hanmi Holdings Co., Ltd Liquid formulations for long-acting erythropoietin conjugate
UA108636C2 (xx) 2010-02-17 2015-05-25 Пептид
RS59978B1 (sr) 2010-08-11 2020-03-31 Ironwood Pharmaceuticals Inc Stabilne formulacije linaklotida
KR101303388B1 (ko) 2010-10-26 2013-09-03 한미사이언스 주식회사 지속형 인터페론 알파 결합체의 액상 제제
DK2776055T3 (en) 2011-08-17 2017-03-06 Ironwood Pharmaceuticals Inc TREATMENTS FOR GASTROINTESTINAL DISORDERS
RU2015143521A (ru) * 2013-03-13 2017-04-19 Илэвэн Байотерапьютикс, Инк. Лекарственные формы химерных цитокинов для глазной доставки
EP2832361A1 (en) * 2013-07-29 2015-02-04 Ipsen Pharma S.A.S. Aqueous sustained release compositions of LHRH analogs
DK3287141T3 (da) * 2015-04-21 2021-10-11 Staidson Beijing Biopharmaceuticals Co Ltd Nervevækstfaktorsammensætning og injektionspulver
WO2023098844A1 (zh) * 2021-12-03 2023-06-08 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
CA2319672C (en) * 1997-02-07 2011-01-04 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
WO2000015241A1 (fr) * 1998-09-11 2000-03-23 Chugai Seiyaku Kabushiki Kaisha Preparation d'une solution proteinique et son procede de stabilisation
CA2369444C (en) 1999-04-09 2009-08-18 Ortho-Mcneil Pharmaceutical, Inc. Pharmaceutical compositions of erythropoietin
AU6875900A (en) * 1999-09-08 2001-04-10 Chugai Seiyaku Kabushiki Kaisha Protein solution preparation and method of stabilizing the same
AU2001236005A1 (en) * 2000-02-29 2001-09-12 Chugai Seiyaku Kabushiki Kaisha Preparations stabilized over long time
EP1525889A1 (en) * 2000-05-15 2005-04-27 F. Hoffmann-La Roche Ag Liquid pharmaceutical composition containing an erythropoietin derivative
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
JP2007528842A (ja) 2007-10-18
NZ543859A (en) 2008-01-31
EP1641486A4 (en) 2008-10-08
PL379272A1 (pl) 2006-08-21
BRPI0411114B1 (pt) 2020-09-15
CN1802171B (zh) 2010-10-13
MXPA05013398A (es) 2006-03-09
AU2004244920A1 (en) 2004-12-16
US20070293419A1 (en) 2007-12-20
EP1641486B1 (en) 2012-04-18
UA82241C2 (ru) 2008-03-25
EA009676B1 (ru) 2008-02-28
AU2004244920B2 (en) 2009-07-23
US8119595B2 (en) 2012-02-21
CA2528988C (en) 2012-05-01
CN1802171A (zh) 2006-07-12
KR20040110994A (ko) 2004-12-31
EP1641486A1 (en) 2006-04-05
CA2528988A1 (en) 2004-12-16
HK1093012A1 (en) 2007-02-23
WO2004108152A1 (en) 2004-12-16
ES2385888T3 (es) 2012-08-02
NO20055747L (no) 2006-03-07
NO20055747D0 (no) 2005-12-05
ATE553747T1 (de) 2012-05-15
BRPI0411114A (pt) 2006-07-18
BRPI0411114B8 (pt) 2021-05-25
JP4871720B2 (ja) 2012-02-08
ZA200509222B (en) 2006-09-27
KR100610003B1 (ko) 2006-08-08

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Legal Events

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MM4A Lapse of a eurasian patent due to non-payment of renewal fees within the time limit in the following designated state(s)

Designated state(s): AM KG MD TJ

PD4A Registration of transfer of a eurasian patent in accordance with the succession in title