CA2458386C - L-methionine as a stabilizer for nesp/epo in hsa-free formulations - Google Patents

L-methionine as a stabilizer for nesp/epo in hsa-free formulations Download PDF

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Publication number
CA2458386C
CA2458386C CA2458386A CA2458386A CA2458386C CA 2458386 C CA2458386 C CA 2458386C CA 2458386 A CA2458386 A CA 2458386A CA 2458386 A CA2458386 A CA 2458386A CA 2458386 C CA2458386 C CA 2458386C
Authority
CA
Canada
Prior art keywords
nesp
methionine
epo
formulations
free
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
CA2458386A
Other languages
English (en)
French (fr)
Other versions
CA2458386A1 (en
Inventor
Tiansheng Li
Byeong S. Chang
Christopher Sloey
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 K A Inc
Original Assignee
Kirin Amgen Inc
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=25483206&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2458386(C) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Kirin Amgen Inc filed Critical Kirin Amgen Inc
Publication of CA2458386A1 publication Critical patent/CA2458386A1/en
Application granted granted Critical
Publication of CA2458386C publication Critical patent/CA2458386C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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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
    • A61K47/06Organic 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
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Diabetes (AREA)
  • Organic Chemistry (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
CA2458386A 2001-08-30 2002-08-29 L-methionine as a stabilizer for nesp/epo in hsa-free formulations Expired - Lifetime CA2458386C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/945,517 2001-08-30
US09/945,517 US20030104996A1 (en) 2001-08-30 2001-08-30 L-methionine as a stabilizer for NESP/EPO in HSA-free formulations
PCT/US2002/027855 WO2003020299A1 (en) 2001-08-30 2002-08-29 L-methionine as a stabilizer for nesp/epo in hsa-free formulations

Publications (2)

Publication Number Publication Date
CA2458386A1 CA2458386A1 (en) 2003-03-13
CA2458386C true CA2458386C (en) 2012-05-08

Family

ID=25483206

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2458386A Expired - Lifetime CA2458386C (en) 2001-08-30 2002-08-29 L-methionine as a stabilizer for nesp/epo in hsa-free formulations

Country Status (10)

Country Link
US (1) US20030104996A1 (https=)
EP (1) EP1439848B1 (https=)
JP (2) JP4493334B2 (https=)
KR (1) KR100596610B1 (https=)
CN (1) CN100384468C (https=)
CA (1) CA2458386C (https=)
MX (1) MXPA04001774A (https=)
PL (1) PL374122A1 (https=)
TW (1) TWI327068B (https=)
WO (1) WO2003020299A1 (https=)

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US20030104996A1 (en) * 2001-08-30 2003-06-05 Tiansheng Li L-methionine as a stabilizer for NESP/EPO in HSA-free formulations
US7141544B2 (en) * 2003-10-10 2006-11-28 Baxter International, Inc. Stabilization of pharmaceutical protein formulations with small peptides
AU2006295340B2 (en) * 2005-08-05 2010-11-11 Amgen Inc. Stable aqueous protein or antibody pharmaceutical formulations and their preparation
US8137677B2 (en) * 2005-10-06 2012-03-20 Allergan, Inc. Non-protein stabilized clostridial toxin pharmaceutical compositions
US8168206B1 (en) 2005-10-06 2012-05-01 Allergan, Inc. Animal protein-free pharmaceutical compositions
TW200806317A (en) * 2006-03-20 2008-02-01 Wyeth Corp Methods for reducing protein aggregation
EP2170268A2 (en) * 2007-06-25 2010-04-07 Amgen, Inc. Compositions of specific binding agents to hepatocyte growth factor
WO2009009406A1 (en) * 2007-07-06 2009-01-15 Smithkline Beecham Corporation Antibody formulations
EP2219602A1 (en) 2007-11-15 2010-08-25 Amgen, Inc Aqueous formulation of erythropoiesis stimulating protein stablised by antioxidants for parenteral administration
EP2249801A2 (en) * 2008-02-07 2010-11-17 Amgen Inc. Stabilized protein compositions
CN117530912A (zh) 2008-08-15 2024-02-09 硬木药品公司 适合口服给药的鸟苷酸环化酶-c受体激动剂多肽的稳定的固体制剂
BRPI0918978A2 (pt) * 2008-09-10 2015-12-01 Genentech Inc composições e métodos a prevenção da degradação oxidativa das proteínas
CA2765220A1 (en) * 2009-07-14 2011-01-20 Biogen Idec Ma Inc. Methods for inhibiting yellow color and peroxide formation in a composition
CA2770077A1 (en) * 2009-08-06 2011-02-10 Ironwood Pharmaceuticals, Inc. Formulations comprising linaclotide
FR2954325B1 (fr) 2009-12-23 2012-02-03 Flamel Tech Sa Polymere amphiphile fonctionnalise par la methionine
US20110150837A1 (en) * 2009-12-23 2011-06-23 Flamel Technologies Amphiphilic polymer functionalized by methionine
MX2012007676A (es) * 2009-12-29 2012-08-03 Hoffmann La Roche Nueva formulacion de anticuerpo.
CN107412737A (zh) 2010-01-19 2017-12-01 韩美科学株式会社 长效g‑csf缀合物的液体制剂
EP2364690A1 (en) 2010-02-12 2011-09-14 Centro De Ingenieria Genetica Y Biotecnologia Orally administrable pharmaceutical pellet of epidermal growth factor
US8933030B2 (en) 2010-02-17 2015-01-13 Ironwwod Pharmaceuticals, Inc. Treatments for gastrointestinal disorders
DK2603232T3 (da) 2010-08-11 2019-12-09 Ironwood Pharmaceuticals Inc Stabile formuleringer af linaclotid
KR101303388B1 (ko) * 2010-10-26 2013-09-03 한미사이언스 주식회사 지속형 인터페론 알파 결합체의 액상 제제
US9708371B2 (en) 2011-08-17 2017-07-18 Ironwood Pharmaceuticals, Inc. Treatments for gastrointestinal disorders
AU2012328524B2 (en) 2011-10-28 2017-05-18 Excelse Bio, Inc. Protein formulations containing amino acids
AR092862A1 (es) * 2012-07-25 2015-05-06 Hanmi Pharm Ind Co Ltd Formulacion liquida de insulina de accion prolongada y un peptido insulinotropico y metodo de preparacion
US9663563B2 (en) 2013-03-12 2017-05-30 Sumitomo Dainippon Pharma Co., Ltd. Aqueous liquid composition
SG10201707477SA (en) * 2013-03-13 2017-10-30 Eleven Biotherapeutics Inc Chimeric cytokine formulations for ocular delivery
JP6541581B2 (ja) 2013-03-15 2019-07-10 グラクソスミスクライン、インテレクチュアル、プロパティー、(ナンバー2)、リミテッドGlaxosmithkline Intellectual Property (No.2) Limited 低濃度抗体製剤
EP3094735A1 (en) * 2014-01-13 2016-11-23 Amgen Inc. Regulating ornithine metabolism to manipulate the high mannose glycoform content of recombinant proteins
AR103173A1 (es) 2014-12-22 2017-04-19 Novarits Ag Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17
RU2599031C1 (ru) * 2015-08-11 2016-10-10 Общество с ограниченной ответственностью "АйВиФарма" Водная композиция рекомбинантного фолликулостимулирующего гормона человека (варианты)
EP3397243A1 (en) * 2015-12-30 2018-11-07 H. Hoffnabb-La Roche Ag Use of tryptophan derivatives for protein formulations
BR112019004935A2 (pt) 2016-09-13 2019-06-04 Allergan, Inc. composições de toxina clostridial não proteíca estabilizada
US11338018B2 (en) 2016-12-19 2022-05-24 Harrow Ip, Llc Adrenocorticotropic hormone-based pharmaceutical formulations and methods for fabricating and using thereof
WO2018142514A1 (ja) * 2017-02-01 2018-08-09 協和発酵キリン株式会社 ダルベポエチンを含む液体医薬組成物
US11110063B2 (en) 2017-08-25 2021-09-07 MAIA Pharmaceuticals, Inc. Storage stable sincalide formulations
KR102655498B1 (ko) 2017-09-07 2024-04-11 제이씨알 파마 가부시키가이샤 수성 의약 조성물
US20210283238A1 (en) 2018-08-07 2021-09-16 Glaxosmithkline Biologicals Sa Novel processes and vaccines
BR112021004649A2 (pt) * 2018-09-13 2021-06-01 F. Hoffmann-La Roche Ag formulação farmacêutica e uso de uma formulação
US20210251970A1 (en) 2018-10-10 2021-08-19 Presbyopia Therapies Inc Compositions and methods for storage stable ophthalmic drugs
US12180206B2 (en) 2021-11-17 2024-12-31 Lenz Therapeutics Operations, Inc. Aceclidine derivatives, compositions thereof and methods of use thereof
US20250032579A1 (en) * 2021-12-03 2025-01-30 Jecho Biopharmaceuticals Co., Ltd. Formulation, and preparation method therefor and use thereof
US11648247B1 (en) 2021-12-16 2023-05-16 Lenz Therapeutics, Inc. Compositions and methods for the treatment of presbyopia
US12414942B1 (en) 2024-03-15 2025-09-16 Lenz Therapeutics Operations, Inc. Compositions, methods, and systems for treating presbyopia

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Also Published As

Publication number Publication date
JP2005527470A (ja) 2005-09-15
EP1439848A4 (en) 2009-06-24
HK1075198A1 (zh) 2005-12-09
MXPA04001774A (es) 2004-11-22
CN100384468C (zh) 2008-04-30
EP1439848A1 (en) 2004-07-28
CA2458386A1 (en) 2003-03-13
KR100596610B1 (ko) 2006-07-06
EP1439848B1 (en) 2014-11-26
CN1592629A (zh) 2005-03-09
KR20040044194A (ko) 2004-05-27
US20030104996A1 (en) 2003-06-05
TWI327068B (en) 2010-07-11
WO2003020299A1 (en) 2003-03-13
PL374122A1 (en) 2005-10-03
JP2010138195A (ja) 2010-06-24
JP4493334B2 (ja) 2010-06-30

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Effective date: 20220829