JP7357540B2 - 液体医薬組成物 - Google Patents

液体医薬組成物 Download PDF

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Publication number
JP7357540B2
JP7357540B2 JP2019548380A JP2019548380A JP7357540B2 JP 7357540 B2 JP7357540 B2 JP 7357540B2 JP 2019548380 A JP2019548380 A JP 2019548380A JP 2019548380 A JP2019548380 A JP 2019548380A JP 7357540 B2 JP7357540 B2 JP 7357540B2
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liquid pharmaceutical
pharmaceutical composition
adalimumab
polyol
edta
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Japanese (ja)
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JP2020511440A (ja
JP2020511440A5 (enExample
Inventor
バディアリ ルカ
ジェリング デビッド
ジェゼク ジャン
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アレコル リミテッド
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Priority to JP2023018934A priority Critical patent/JP2023058632A/ja
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    • 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
    • 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
    • A61K47/06Organic 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
    • A61K9/0012Galenical 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
    • 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
    • C07K16/241Tumor Necrosis Factors
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
JP2019548380A 2017-03-06 2018-03-06 液体医薬組成物 Active JP7357540B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2023018934A JP2023058632A (ja) 2017-03-06 2023-02-10 液体医薬組成物

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP17159460.9 2017-03-06
EP17159460.9A EP3372242A1 (en) 2017-03-06 2017-03-06 Liquid pharmaceutical composition
PCT/EP2018/055505 WO2018162500A1 (en) 2017-03-06 2018-03-06 Liquid pharmaceutical composition

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2023018934A Division JP2023058632A (ja) 2017-03-06 2023-02-10 液体医薬組成物

Publications (3)

Publication Number Publication Date
JP2020511440A JP2020511440A (ja) 2020-04-16
JP2020511440A5 JP2020511440A5 (enExample) 2021-04-08
JP7357540B2 true JP7357540B2 (ja) 2023-10-06

Family

ID=58261543

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2019548380A Active JP7357540B2 (ja) 2017-03-06 2018-03-06 液体医薬組成物
JP2023018934A Pending JP2023058632A (ja) 2017-03-06 2023-02-10 液体医薬組成物

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2023018934A Pending JP2023058632A (ja) 2017-03-06 2023-02-10 液体医薬組成物

Country Status (4)

Country Link
US (2) US11534402B2 (enExample)
EP (2) EP3372242A1 (enExample)
JP (2) JP7357540B2 (enExample)
WO (1) WO2018162500A1 (enExample)

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US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
EP4467565A3 (en) 2016-12-21 2025-03-12 Amgen Inc. Anti-tnf alpha antibody formulations
US11608357B2 (en) 2018-08-28 2023-03-21 Arecor Limited Stabilized antibody protein solutions
EP3372241A1 (en) 2017-03-06 2018-09-12 Ares Trading S.A. Liquid pharmaceutical composition
EP3372242A1 (en) 2017-03-06 2018-09-12 Ares Trading S.A. Liquid pharmaceutical composition
MA55033A (fr) * 2019-02-18 2021-12-29 Lilly Co Eli Formulation d'anticorps thérapeutique
US20230203147A1 (en) * 2019-03-18 2023-06-29 Alvotech Hf Aqueous formulations of tnf-alpha antibodies in high concentrations

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2015506369A (ja) 2012-01-30 2015-03-02 アレコー リミテッド 安定化された水性抗体組成物
JP2015527402A (ja) 2012-09-07 2015-09-17 コヒラス・バイオサイエンシズ・インコーポレイテッド 安定水性アダリムマブ製剤
WO2016066688A1 (en) 2014-10-28 2016-05-06 Richter Gedeon Nyrt. Pharmaceutical anti-tnf-alpha antibody formulation
JP2016117732A (ja) 2014-12-23 2016-06-30 ファイザー・インク 安定な水性抗体製剤

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BRPI9707379B8 (pt) 1996-02-09 2015-07-07 Abbvie Biotechnology Ltd Composições farmacêuticas compreendendo anticorpo humano recombinante geneticamente engenheirado, e anticorpo humano recombinante geneticamente engenheirado.
ATE291436T2 (de) 2000-05-15 2005-04-15 Hoffmann La Roche Flüssige arzneizubereitung enthaltend ein erythropoietin derivat
CA2466034C (en) 2001-11-08 2012-12-18 Protein Design Labs, Inc. Stable aqueous pharmaceutical formulations of daclizumab antibodies
PT1946776T (pt) 2002-02-27 2017-03-17 Immunex Corp Composição de tnfr-fc estabilizada compreendendo arginina
WO2004007520A2 (en) 2002-07-12 2004-01-22 Medarex, Inc. Methods and compositions for preventing oxidative degradation of proteins
US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
PA8661401A1 (es) 2005-01-28 2006-09-08 Wyeth Corp Formulaciones del liquido polipeptido estabilizado
AR054233A1 (es) 2005-03-08 2007-06-13 Pharmacia & Upjohn Co Llc Composiciones de anticuerpos igg2
TW200806317A (en) 2006-03-20 2008-02-01 Wyeth Corp Methods for reducing protein aggregation
JP5631591B2 (ja) 2006-10-06 2014-11-26 アムジエン・インコーポレーテツド 安定な抗体製剤
MX2009003982A (es) 2006-10-20 2009-04-27 Amgen Inc Formulaciones de polipeptido estables.
GB0700523D0 (en) 2007-01-11 2007-02-21 Insense Ltd The Stabilisation Of Proteins
JP2010529999A (ja) 2007-06-14 2010-09-02 バイオジェン・アイデック・エムエイ・インコーポレイテッド 抗体製剤
PE20091174A1 (es) 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
WO2010062896A1 (en) 2008-11-28 2010-06-03 Abbott Laboratories Stable antibody compositions and methods for stabilizing same
CN104490767A (zh) * 2009-05-04 2015-04-08 艾伯维生物技术有限公司 人抗TNF-α抗体的稳定高蛋白质浓度制剂
EP2598167B1 (en) 2010-07-30 2015-04-01 Arecor Limited Stabilized aqueous antibody compositions
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GB201703062D0 (en) 2017-02-24 2017-04-12 Arecor Ltd Stabilized antibody protein solutions
US20200069799A1 (en) 2018-08-28 2020-03-05 Arecor Limited Stabilized antibody protein solutions
GB201703063D0 (en) 2017-02-24 2017-04-12 Arecor Ltd Stabilized antibody protein solutions
EP3372242A1 (en) 2017-03-06 2018-09-12 Ares Trading S.A. Liquid pharmaceutical composition
EP3372241A1 (en) 2017-03-06 2018-09-12 Ares Trading S.A. Liquid pharmaceutical composition
WO2018184692A1 (en) 2017-04-07 2018-10-11 Ares Trading S.A. Liquid pharmaceutical composition
WO2018184693A1 (en) 2017-04-07 2018-10-11 Ares Trading S.A. Liquid pharmaceutical composition

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2015506369A (ja) 2012-01-30 2015-03-02 アレコー リミテッド 安定化された水性抗体組成物
JP2015527402A (ja) 2012-09-07 2015-09-17 コヒラス・バイオサイエンシズ・インコーポレイテッド 安定水性アダリムマブ製剤
WO2016066688A1 (en) 2014-10-28 2016-05-06 Richter Gedeon Nyrt. Pharmaceutical anti-tnf-alpha antibody formulation
JP2016117732A (ja) 2014-12-23 2016-06-30 ファイザー・インク 安定な水性抗体製剤

Non-Patent Citations (2)

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Int.J.Pharm.,1999年,Vol.185,No.2,pp.129-188
Pharm.Res.,2010年,Vol.27,No.4,544-575

Also Published As

Publication number Publication date
WO2018162500A1 (en) 2018-09-13
JP2020511440A (ja) 2020-04-16
US20230330014A1 (en) 2023-10-19
JP2023058632A (ja) 2023-04-25
EP3372242A1 (en) 2018-09-12
EP3592383A1 (en) 2020-01-15
US11534402B2 (en) 2022-12-27
EP3592383B1 (en) 2022-05-04
US20200016074A1 (en) 2020-01-16

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