TWI327068B - 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
TWI327068B
TWI327068B TW091119907A TW91119907A TWI327068B TW I327068 B TWI327068 B TW I327068B TW 091119907 A TW091119907 A TW 091119907A TW 91119907 A TW91119907 A TW 91119907A TW I327068 B TWI327068 B TW I327068B
Authority
TW
Taiwan
Prior art keywords
nesp
composition
methionine
formulation
epo
Prior art date
Application number
TW091119907A
Other languages
English (en)
Chinese (zh)
Inventor
Li Tiansheng
S Chang Byeong
Sloey Christopher
Original Assignee
Kirin Amgen Inc
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Publication date
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Application filed by Kirin Amgen Inc filed Critical Kirin Amgen Inc
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Publication of TWI327068B publication Critical patent/TWI327068B/zh

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    • 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)
  • Immunology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
TW091119907A 2001-08-30 2002-08-29 L-methionine as a stabilizer for nesp/epo in hsa-free formulations TWI327068B (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US09/945,517 US20030104996A1 (en) 2001-08-30 2001-08-30 L-methionine as a stabilizer for NESP/EPO in HSA-free formulations

Publications (1)

Publication Number Publication Date
TWI327068B true TWI327068B (en) 2010-07-11

Family

ID=25483206

Family Applications (1)

Application Number Title Priority Date Filing Date
TW091119907A TWI327068B (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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TWI494120B (zh) * 2010-10-26 2015-08-01 韓美科學股份有限公司 長效α-型干擾素接合物之液體調配物

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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
US8168206B1 (en) * 2005-10-06 2012-05-01 Allergan, Inc. Animal protein-free pharmaceutical compositions
US8137677B2 (en) * 2005-10-06 2012-03-20 Allergan, Inc. Non-protein stabilized clostridial toxin 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
EP2173163A4 (en) * 2007-07-06 2010-12-08 Glaxosmithkline Llc ANTIBODY FORMULATIONS
US8796206B2 (en) * 2007-11-15 2014-08-05 Amgen Inc. Aqueous formulation of erythropoiesis stimulating protein stabilised by antioxidants for parenteral administration
AU2009210741A1 (en) * 2008-02-07 2009-08-13 Amgen Inc. Stabilized protein compositions
PE20110543A1 (es) 2008-08-15 2011-08-04 Ironwood Pharmaceuticals Inc Formulacion solida oral que comprende linaclotida, cation de calcio y leucina
CN103599541A (zh) * 2008-09-10 2014-02-26 弗·哈夫曼-拉罗切有限公司 用于防止蛋白质氧化降解的组合物和方法
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
BR112012013148A2 (pt) * 2009-12-29 2017-03-21 F Hoffmann - La Roche Ag formulação farmacêutica e uso
PT2525787T (pt) 2010-01-19 2017-12-18 Hanmi Science Co Ltd Formulações líquidas para conjugado de g-csf de longa ação
EP2364690A1 (en) * 2010-02-12 2011-09-14 Centro De Ingenieria Genetica Y Biotecnologia Orally administrable pharmaceutical pellet of epidermal growth factor
UA108636C2 (xx) 2010-02-17 2015-05-25 Пептид
EP2603232B1 (en) 2010-08-11 2019-09-25 Ironwood Pharmaceuticals, Inc. Stable formulations of linaclotide
MX347354B (es) 2011-08-17 2017-04-24 Ironwood Pharmaceuticals Inc Tratamientos para trastornos gastrointestinales.
CN108771655A (zh) 2011-10-28 2018-11-09 诚信生物公司 含有氨基酸的蛋白质制剂
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
EP2974734B1 (en) 2013-03-12 2018-10-10 Sumitomo Dainippon Pharma Co., Ltd. Liquid aqueous composition
EP2968468B1 (en) * 2013-03-13 2021-07-14 Buzzard Pharmaceuticals AB Chimeric cytokine formulations for ocular delivery
AU2014229282B2 (en) 2013-03-15 2017-02-02 Glaxosmithkline Intellectual Property (No.2) Limited Low concentration antibody formulations
BR122020004385B1 (pt) * 2014-01-13 2022-10-04 Amgen Inc Método para aumentar o teor de glicoforma de alta manose de uma glicoproteína recombinante e método de produção de uma glicoproteína recombinante
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)
JP7046814B2 (ja) * 2015-12-30 2022-04-04 ジェネンテック, インコーポレイテッド タンパク質製剤のためのトリプトファン誘導体の使用
KR102480965B1 (ko) 2016-09-13 2022-12-26 알레간 인코포레이티드 안정화된 비단백질 클로스트리듐 독소 조성물
US11338018B2 (en) 2016-12-19 2022-05-24 Harrow Ip, Llc Adrenocorticotropic hormone-based pharmaceutical formulations and methods for fabricating and using thereof
JP6172880B1 (ja) * 2017-02-01 2017-08-02 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
CN111278453A (zh) 2017-09-07 2020-06-12 Jcr制药股份有限公司 水性药物组合物
EP3833382A1 (en) * 2018-08-07 2021-06-16 GlaxoSmithKline Biologicals S.A. Processes and vaccines
CN119857138A (zh) * 2018-09-13 2025-04-22 豪夫迈·罗氏有限公司 Csf-1r抗体制剂
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
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
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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US20030104996A1 (en) * 2001-08-30 2003-06-05 Tiansheng Li L-methionine as a stabilizer for NESP/EPO in HSA-free formulations

Cited By (2)

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Publication number Priority date Publication date Assignee Title
TWI494120B (zh) * 2010-10-26 2015-08-01 韓美科學股份有限公司 長效α-型干擾素接合物之液體調配物
US9669105B2 (en) 2010-10-26 2017-06-06 Hanmi Science Co., Ltd. Liquid formulations of long-acting interferon alpha conjugates

Also Published As

Publication number Publication date
JP2010138195A (ja) 2010-06-24
MXPA04001774A (es) 2004-11-22
EP1439848A1 (en) 2004-07-28
JP4493334B2 (ja) 2010-06-30
CA2458386A1 (en) 2003-03-13
PL374122A1 (en) 2005-10-03
EP1439848A4 (en) 2009-06-24
HK1075198A1 (zh) 2005-12-09
CN100384468C (zh) 2008-04-30
EP1439848B1 (en) 2014-11-26
CA2458386C (en) 2012-05-08
KR20040044194A (ko) 2004-05-27
CN1592629A (zh) 2005-03-09
KR100596610B1 (ko) 2006-07-06
WO2003020299A1 (en) 2003-03-13
US20030104996A1 (en) 2003-06-05
JP2005527470A (ja) 2005-09-15

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