JP2014516924A - 粘度が低減された処方物 - Google Patents

粘度が低減された処方物 Download PDF

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Publication number
JP2014516924A
JP2014516924A JP2014504013A JP2014504013A JP2014516924A JP 2014516924 A JP2014516924 A JP 2014516924A JP 2014504013 A JP2014504013 A JP 2014504013A JP 2014504013 A JP2014504013 A JP 2014504013A JP 2014516924 A JP2014516924 A JP 2014516924A
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JP
Japan
Prior art keywords
formulation
viscosity
less
concentration
citrate
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Pending
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JP2014504013A
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English (en)
Japanese (ja)
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JP2014516924A5 (enExample
Inventor
マーナ、エイ.モンク
マン、イ、ウォン
カイ、ツァン
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GlaxoSmithKline LLC
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GlaxoSmithKline LLC
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Publication of JP2014516924A publication Critical patent/JP2014516924A/ja
Publication of JP2014516924A5 publication Critical patent/JP2014516924A5/ja
Pending legal-status Critical Current

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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
    • A61K47/02Inorganic compounds
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244Interleukins [IL]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Mycology (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Endocrinology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Compositions Of Macromolecular Compounds (AREA)
JP2014504013A 2011-04-07 2012-04-06 粘度が低減された処方物 Pending JP2014516924A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161473121P 2011-04-07 2011-04-07
US61/473,121 2011-04-07
PCT/US2012/032462 WO2012138958A1 (en) 2011-04-07 2012-04-06 Formulations with reduced viscosity

Publications (2)

Publication Number Publication Date
JP2014516924A true JP2014516924A (ja) 2014-07-17
JP2014516924A5 JP2014516924A5 (enExample) 2016-01-28

Family

ID=46969561

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2014504013A Pending JP2014516924A (ja) 2011-04-07 2012-04-06 粘度が低減された処方物

Country Status (12)

Country Link
US (1) US20140023655A1 (enExample)
EP (2) EP3058952A1 (enExample)
JP (1) JP2014516924A (enExample)
KR (1) KR20140018966A (enExample)
CN (1) CN103596585A (enExample)
AU (2) AU2012240050B2 (enExample)
BR (1) BR112013025866A2 (enExample)
CA (1) CA2832556A1 (enExample)
EA (1) EA201391488A1 (enExample)
IL (1) IL228591A0 (enExample)
SG (1) SG193963A1 (enExample)
WO (1) WO2012138958A1 (enExample)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2023533704A (ja) * 2020-07-13 2023-08-04 メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフツング 高濃度タンパク質製剤用の粘度低減賦形剤及びそれらの組み合わせ

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NO2523688T3 (enExample) * 2010-01-15 2018-03-10
EP3578203A1 (en) 2011-10-28 2019-12-11 Integritybio Inc. Protein formulations containing amino acids
FR2994390B1 (fr) 2012-08-10 2014-08-15 Adocia Procede d'abaissement de la viscosite de solutions de proteines a concentration elevee
WO2014141149A1 (en) * 2013-03-15 2014-09-18 Glaxosmithkline Intellectual Property (No.2) Limited Formulations with reduced viscosity
WO2014169153A1 (en) * 2013-04-10 2014-10-16 Echogen, Inc. Peptide complexes and therapeutic uses
JP6179939B2 (ja) * 2013-07-09 2017-08-16 国立大学法人 筑波大学 高濃度γグロブリン製剤の粘度低下方法
IL312865B2 (en) 2013-09-11 2025-06-01 Eagle Biologics Inc Liquid protein formulations containing viscosity-lowering agents
SG11201702614SA (en) 2014-10-01 2017-04-27 Eagle Biolog Inc Polysaccharide and nucleic acid formulations containing viscosity-lowering agents
US20180264081A1 (en) * 2015-01-18 2018-09-20 Gloriana Therapeutics Sarl Therapeutic protein formulations
CN116327921A (zh) 2015-08-24 2023-06-27 葛兰素史密斯克莱知识产权(第2 号)有限公司 生物医药组合物
US11603407B2 (en) * 2017-04-06 2023-03-14 Regeneron Pharmaceuticals, Inc. Stable antibody formulation
WO2018211517A1 (en) 2017-05-16 2018-11-22 Bhami's Research Laboratory, Pvt. Ltd. High concentration protein formulations with reduced viscosity
CA3134401A1 (en) 2019-03-29 2020-10-08 Jiangsu Hengrui Medicine Co., Ltd. Pharmaceutical composition containing antibody against il-5 and use thereof

Citations (11)

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JP2004532798A (ja) * 2000-10-12 2004-10-28 ジェネンテック・インコーポレーテッド 粘度の減少した濃縮タンパク質製剤
JP2007511566A (ja) * 2003-11-18 2007-05-10 ツェットエルベー ベーリング アクチエンゲゼルシャフト 安定性を高めた免疫グロブリン配合物
WO2007074880A1 (ja) * 2005-12-28 2007-07-05 Chugai Seiyaku Kabushiki Kaisha 抗体含有安定化製剤
JP2007524602A (ja) * 2003-04-04 2007-08-30 ジェネンテック・インコーポレーテッド 高濃度抗体及びタンパク質製剤
JP2009521482A (ja) * 2005-12-21 2009-06-04 ワイス 低粘度のタンパク質製剤およびその用途
WO2009068649A2 (en) * 2007-11-30 2009-06-04 Glaxo Group Limited Antigen-binding constructs
WO2009084659A1 (ja) * 2007-12-27 2009-07-09 Chugai Seiyaku Kabushiki Kaisha 高濃度抗体含有溶液製剤
JP2010513522A (ja) * 2006-12-21 2010-04-30 アムジエン・インコーポレーテツド ポリペプチドを含有する安定な緩衝化された製剤
JP2013517277A (ja) * 2010-01-15 2013-05-16 キリン−アムジェン・インコーポレーテッド 抗体製剤及び治療レジメン
JP2013518852A (ja) * 2010-02-04 2013-05-23 ツェー・エス・エル・ベーリング・アクチエンゲゼルシャフト 免疫グロブリン製剤
JP2014510152A (ja) * 2011-04-07 2014-04-24 グラクソスミスクライン・リミテッド・ライアビリティ・カンパニー 粘度が低減された処方物

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JPS57106673A (en) 1980-12-24 1982-07-02 Chugai Pharmaceut Co Ltd Dibenzo(b,f)(1,4)oxazepin derivative
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Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004532798A (ja) * 2000-10-12 2004-10-28 ジェネンテック・インコーポレーテッド 粘度の減少した濃縮タンパク質製剤
JP2007524602A (ja) * 2003-04-04 2007-08-30 ジェネンテック・インコーポレーテッド 高濃度抗体及びタンパク質製剤
JP2007511566A (ja) * 2003-11-18 2007-05-10 ツェットエルベー ベーリング アクチエンゲゼルシャフト 安定性を高めた免疫グロブリン配合物
JP2009521482A (ja) * 2005-12-21 2009-06-04 ワイス 低粘度のタンパク質製剤およびその用途
WO2007074880A1 (ja) * 2005-12-28 2007-07-05 Chugai Seiyaku Kabushiki Kaisha 抗体含有安定化製剤
JP2010513522A (ja) * 2006-12-21 2010-04-30 アムジエン・インコーポレーテツド ポリペプチドを含有する安定な緩衝化された製剤
WO2009068649A2 (en) * 2007-11-30 2009-06-04 Glaxo Group Limited Antigen-binding constructs
WO2009084659A1 (ja) * 2007-12-27 2009-07-09 Chugai Seiyaku Kabushiki Kaisha 高濃度抗体含有溶液製剤
JP2013517277A (ja) * 2010-01-15 2013-05-16 キリン−アムジェン・インコーポレーテッド 抗体製剤及び治療レジメン
JP2013518852A (ja) * 2010-02-04 2013-05-23 ツェー・エス・エル・ベーリング・アクチエンゲゼルシャフト 免疫グロブリン製剤
JP2014510152A (ja) * 2011-04-07 2014-04-24 グラクソスミスクライン・リミテッド・ライアビリティ・カンパニー 粘度が低減された処方物

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Title
HE,F. ET AL.: "Screening of monoclonal antibody formulations based on high-throughput thermostability and viscosity", J. PHARM. SCI., vol. 100, no. 4, JPN6016004918, 2 November 2010 (2010-11-02), pages 1330 - 40, XP002696416, ISSN: 0003252724, DOI: 10.1002/jps.22384 *
SHIRE,S.J. ET AL.: "High-concentration antibody formulations.", FORMULATION AND PROCESS DEVELOPMENT STRATEGIES FOR MANUFACTURING BIOPHARMACEUTICALS., JPN6016004923, 1 January 2010 (2010-01-01), pages 349 - 81, XP055050466, ISSN: 0003252723, DOI: 10.1002/9780470595886.ch15 *
SUKUMAR,M. ET AL.: "Opalescent appearance of an IgG1 antibody at high concentrations and its relationship to noncovalent", PHARM. RES., vol. 21, no. 7, JPN6016004920, July 2004 (2004-07-01), pages 1087 - 93, ISSN: 0003252722 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2023533704A (ja) * 2020-07-13 2023-08-04 メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフツング 高濃度タンパク質製剤用の粘度低減賦形剤及びそれらの組み合わせ

Also Published As

Publication number Publication date
EP3058952A1 (en) 2016-08-24
BR112013025866A2 (pt) 2016-12-20
SG193963A1 (en) 2013-11-29
EA201391488A1 (ru) 2014-01-30
CA2832556A1 (en) 2012-10-11
AU2016202355A1 (en) 2016-05-05
AU2012240050B2 (en) 2016-01-21
IL228591A0 (en) 2013-12-31
WO2012138958A1 (en) 2012-10-11
CN103596585A (zh) 2014-02-19
EP2694100A4 (en) 2014-10-01
EP2694100A1 (en) 2014-02-12
KR20140018966A (ko) 2014-02-13
US20140023655A1 (en) 2014-01-23
AU2012240050A1 (en) 2013-10-17

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