CN100384468C - L-甲硫氨酸在无hsa的制剂中用作nesp/epo的稳定剂 - Google Patents

L-甲硫氨酸在无hsa的制剂中用作nesp/epo的稳定剂 Download PDF

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Publication number
CN100384468C
CN100384468C CNB028217098A CN02821709A CN100384468C CN 100384468 C CN100384468 C CN 100384468C CN B028217098 A CNB028217098 A CN B028217098A CN 02821709 A CN02821709 A CN 02821709A CN 100384468 C CN100384468 C CN 100384468C
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China
Prior art keywords
nesp
methionine
epo
formulation
free
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Expired - Lifetime
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CNB028217098A
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English (en)
Chinese (zh)
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CN1592629A (zh
Inventor
T·李
B·S·常
C·斯勒伊
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Amgen K A Inc
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Kirin Amgen Inc
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    • 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
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic 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
    • 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

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  • 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)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
CNB028217098A 2001-08-30 2002-08-29 L-甲硫氨酸在无hsa的制剂中用作nesp/epo的稳定剂 Expired - Lifetime CN100384468C (zh)

Applications Claiming Priority (2)

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

Publications (2)

Publication Number Publication Date
CN1592629A CN1592629A (zh) 2005-03-09
CN100384468C true CN100384468C (zh) 2008-04-30

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CNB028217098A Expired - Lifetime CN100384468C (zh) 2001-08-30 2002-08-29 L-甲硫氨酸在无hsa的制剂中用作nesp/epo的稳定剂

Country Status (10)

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

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US8137677B2 (en) * 2005-10-06 2012-03-20 Allergan, Inc. Non-protein stabilized clostridial toxin pharmaceutical compositions
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US7951368B2 (en) * 2007-06-25 2011-05-31 Amgen Inc. Compositions of specific binding agents to hepatocyte growth factor
US20100189721A1 (en) * 2007-07-06 2010-07-29 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
CA2714006A1 (en) * 2008-02-07 2009-08-13 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
KR20110076918A (ko) * 2008-09-10 2011-07-06 제넨테크, 인크. 단백질의 산화성 분해를 방지하기 위한 조성물 및 방법
CA2765220A1 (en) * 2009-07-14 2011-01-20 Biogen Idec Ma Inc. Methods for inhibiting yellow color and peroxide formation in a composition
MX2012001660A (es) * 2009-08-06 2012-03-26 Ironwood Pharmaceuticals Inc Formulaciones que contienen linaclotida para adminstracion oral.
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
WO2011080209A2 (en) * 2009-12-29 2011-07-07 F. Hoffmann-La Roche Ag Novel antibody formulation
BR112012017979B1 (pt) 2010-01-19 2021-10-13 Hanmi Science Co., Ltd. Formulações líquidas para conjugado de g-csf de ação prolongada
EP2364690A1 (en) * 2010-02-12 2011-09-14 Centro De Ingenieria Genetica Y Biotecnologia Orally administrable pharmaceutical pellet of epidermal growth factor
EA201290799A1 (ru) 2010-02-17 2013-03-29 Айронвуд Фармасьютикалз, Инк. Лечение желудочно-кишечных расстройств
LT2603232T (lt) 2010-08-11 2020-01-27 Ironwood Pharmaceuticals, Inc. Stabilios linaklotido vaisto formos
KR101303388B1 (ko) 2010-10-26 2013-09-03 한미사이언스 주식회사 지속형 인터페론 알파 결합체의 액상 제제
MX347354B (es) 2011-08-17 2017-04-24 Ironwood Pharmaceuticals Inc Tratamientos para trastornos gastrointestinales.
WO2013063510A1 (en) 2011-10-28 2013-05-02 Integritybio 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
KR20150126042A (ko) 2013-03-12 2015-11-10 다이닛본 스미토모 세이야꾸 가부시끼가이샤 액체 수성 조성물
SG10201707477SA (en) * 2013-03-13 2017-10-30 Eleven Biotherapeutics Inc Chimeric cytokine formulations for ocular delivery
TW201501724A (zh) 2013-03-15 2015-01-16 Glaxosmithkline Ip No 2 Ltd 低濃度抗體調配物
MX376230B (es) * 2014-01-13 2025-03-07 Amgen Inc Regulación del metábolismo de ornitina para manipular el contenido de glicoformas ricas en manosa de proteínas recombinantes.
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)
CA3007491A1 (en) * 2015-12-30 2017-07-06 Genentech, Inc. Use of tryptophan derivatives for protein formulations
HUE046449T2 (hu) 2016-09-13 2020-03-30 Allergan Inc Stabilizált, nem fehérje eredetû, clostridiális toxin készítmények
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
US11932699B2 (en) 2017-09-07 2024-03-19 Jcr Pharmaceuticals Co., Ltd. Aqueous pharmaceutical composition
WO2020030572A1 (en) 2018-08-07 2020-02-13 Glaxosmithkline Biologicals Sa Processes and vaccines
AU2019339740B2 (en) * 2018-09-13 2025-06-26 F. Hoffmann-La Roche Ag CSF-1R antibody formulation
US20210251970A1 (en) 2018-10-10 2021-08-19 Presbyopia Therapies Inc Compositions and methods for storage stable ophthalmic drugs
WO2023091439A1 (en) 2021-11-17 2023-05-25 Lenz Therapeutics, 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

Citations (3)

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US4835260A (en) * 1987-03-20 1989-05-30 Genetics Institute, Inc. Erythropoietin composition
US5272135A (en) * 1991-03-01 1993-12-21 Chiron Ophthalmics, Inc. Method for the stabilization of methionine-containing polypeptides
CN1191139A (zh) * 1997-01-15 1998-08-26 阿克佐诺贝尔公司 含有促性腺素的液体制剂

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NZ210501A (en) * 1983-12-13 1991-08-27 Kirin Amgen Inc Erythropoietin produced by procaryotic or eucaryotic expression of an exogenous dna sequence
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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

Patent Citations (3)

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US4835260A (en) * 1987-03-20 1989-05-30 Genetics Institute, Inc. Erythropoietin composition
US5272135A (en) * 1991-03-01 1993-12-21 Chiron Ophthalmics, Inc. Method for the stabilization of methionine-containing polypeptides
CN1191139A (zh) * 1997-01-15 1998-08-26 阿克佐诺贝尔公司 含有促性腺素的液体制剂

Also Published As

Publication number Publication date
US20030104996A1 (en) 2003-06-05
MXPA04001774A (es) 2004-11-22
KR100596610B1 (ko) 2006-07-06
TWI327068B (en) 2010-07-11
JP2005527470A (ja) 2005-09-15
JP4493334B2 (ja) 2010-06-30
KR20040044194A (ko) 2004-05-27
EP1439848A1 (en) 2004-07-28
JP2010138195A (ja) 2010-06-24
HK1075198A1 (zh) 2005-12-09
PL374122A1 (en) 2005-10-03
EP1439848A4 (en) 2009-06-24
EP1439848B1 (en) 2014-11-26
CA2458386C (en) 2012-05-08
CA2458386A1 (en) 2003-03-13
CN1592629A (zh) 2005-03-09
WO2003020299A1 (en) 2003-03-13

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