MXPA05013398A - Solucion estable acuosa de eritropoyetina de origen humano, que no contiene albumina de suero. - Google Patents

Solucion estable acuosa de eritropoyetina de origen humano, que no contiene albumina de suero.

Info

Publication number
MXPA05013398A
MXPA05013398A MXPA05013398A MXPA05013398A MXPA05013398A MX PA05013398 A MXPA05013398 A MX PA05013398A MX PA05013398 A MXPA05013398 A MX PA05013398A MX PA05013398 A MXPA05013398 A MX PA05013398A MX PA05013398 A MXPA05013398 A MX PA05013398A
Authority
MX
Mexico
Prior art keywords
human erythropoietin
serum albumin
stable
aqueous solution
containing serum
Prior art date
Application number
MXPA05013398A
Other languages
English (en)
Inventor
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=MXPA05013398(A) "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
Publication of MXPA05013398A publication Critical patent/MXPA05013398A/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18Growth factors; Growth regulators
    • A61K38/1816Erythropoietin [EPO]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06Antianaemics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biochemistry (AREA)
  • Zoology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Diabetes (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

La presente invencion provee una formulacion acuosa de eritropoyetina de origen humano que tiene estabilidad durante el almacenamiento por un largo periodo de tiempo sin albumina de suero, en donde la formulacion comprende una cantidad terapeuticamente efectiva de eritropoyetina de origen humano; agente tensioactivo no ionico, alcohol polihidrico aminoacido neutral y alcohol de azucar como los estabilizadores; reactivo isotonico; y reactivo regulador de pH.
MXPA05013398A 2003-06-10 2004-06-07 Solucion estable acuosa de eritropoyetina de origen humano, que no contiene albumina de suero. MXPA05013398A (es)

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
MXPA05013398A true MXPA05013398A (es) 2006-03-09

Family

ID=36337525

Family Applications (1)

Application Number Title Priority Date Filing Date
MXPA05013398A MXPA05013398A (es) 2003-06-10 2004-06-07 Solucion estable acuosa de eritropoyetina de origen humano, que no contiene albumina de suero.

Country Status (19)

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

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW200640492A (en) 2005-02-21 2006-12-01 Lg Life Sciences Ltd Sustained release composition of protein drug
US8546329B2 (en) * 2006-03-22 2013-10-01 Chugai Seiyaku Kabushiki Kaisha Erythropoietin solution preparation
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
EP2219602A1 (en) 2007-11-15 2010-08-25 Amgen, Inc Aqueous formulation of erythropoiesis stimulating protein stablised by antioxidants for parenteral administration
WO2010019266A2 (en) * 2008-08-15 2010-02-18 Ironwood Pharmaceuticals, Inc. Stable solid formulation of a gc-c receptor agonist polypeptide suitable for oral administration
MX2012001660A (es) * 2009-08-06 2012-03-26 Ironwood Pharmaceuticals Inc Formulaciones que contienen linaclotida para adminstracion oral.
BR112012017982A2 (pt) * 2010-01-19 2016-05-03 Hanmi Science Co Ltd formulações líquidas para conjugado de eritropoietina de longa ação
DK2536742T3 (en) 2010-02-17 2017-09-04 Ironwood Pharmaceuticals Inc TREATMENTS FOR GASTROINTESTINAL DISORDERS
US20140005128A1 (en) 2010-08-11 2014-01-02 Forest Laboratories Holdings Limited Treatments of gastrointestinal disorders
KR101303388B1 (ko) 2010-10-26 2013-09-03 한미사이언스 주식회사 지속형 인터페론 알파 결합체의 액상 제제
WO2013025969A1 (en) 2011-08-17 2013-02-21 Ironwood Pharmaceuticals, Inc. Treatments for gastrointestinal disorders
AU2014243839B2 (en) * 2013-03-13 2019-01-03 Buzzard Pharmaceuticals AB Chimeric cytokine formulations for ocular delivery
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
EP1015008B1 (en) * 1997-02-07 2015-08-05 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
JP2002541208A (ja) * 1999-04-09 2002-12-03 オーソ−マクニール・フアーマシユーチカル・インコーポレーテツド エリトロポイエチンの薬剤組成物
ATE389414T1 (de) * 1999-09-08 2008-04-15 Chugai Pharmaceutical Co Ltd 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
DK1311285T4 (en) 2000-05-15 2017-07-24 Hoffmann La Roche 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
BRPI0411114B1 (pt) 2020-09-15
ATE553747T1 (de) 2012-05-15
CN1802171A (zh) 2006-07-12
BRPI0411114B8 (pt) 2021-05-25
UA82241C2 (uk) 2008-03-25
CA2528988A1 (en) 2004-12-16
KR20040110994A (ko) 2004-12-31
AU2004244920B2 (en) 2009-07-23
HK1093012A1 (en) 2007-02-23
EP1641486A4 (en) 2008-10-08
EP1641486A1 (en) 2006-04-05
JP2007528842A (ja) 2007-10-18
EP1641486B1 (en) 2012-04-18
CA2528988C (en) 2012-05-01
ES2385888T3 (es) 2012-08-02
JP4871720B2 (ja) 2012-02-08
NZ543859A (en) 2008-01-31
EA009676B1 (ru) 2008-02-28
KR100610003B1 (ko) 2006-08-08
US8119595B2 (en) 2012-02-21
AU2004244920A1 (en) 2004-12-16
EA200501789A1 (ru) 2006-06-30
NO20055747D0 (no) 2005-12-05
ZA200509222B (en) 2006-09-27
US20070293419A1 (en) 2007-12-20
PL379272A1 (pl) 2006-08-21
CN1802171B (zh) 2010-10-13
WO2004108152A1 (en) 2004-12-16
NO20055747L (no) 2006-03-07
BRPI0411114A (pt) 2006-07-18

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