JP7220664B2 - 液体医薬組成物 - Google Patents

液体医薬組成物 Download PDF

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Publication number
JP7220664B2
JP7220664B2 JP2019548458A JP2019548458A JP7220664B2 JP 7220664 B2 JP7220664 B2 JP 7220664B2 JP 2019548458 A JP2019548458 A JP 2019548458A JP 2019548458 A JP2019548458 A JP 2019548458A JP 7220664 B2 JP7220664 B2 JP 7220664B2
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Prior art keywords
liquid pharmaceutical
adalimumab
pharmaceutical composition
arginine
composition
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Japanese (ja)
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JP2020511443A5 (https=
JP2020511443A (ja
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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    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241—Tumor Necrosis Factors
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins 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)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
JP2019548458A 2017-03-06 2018-03-06 液体医薬組成物 Active JP7220664B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP17159458.3A EP3372241A1 (en) 2017-03-06 2017-03-06 Liquid pharmaceutical composition
EP17159458.3 2017-03-06
PCT/EP2018/055509 WO2018162503A1 (en) 2017-03-06 2018-03-06 Liquid pharmaceutical composition

Publications (3)

Publication Number Publication Date
JP2020511443A JP2020511443A (ja) 2020-04-16
JP2020511443A5 JP2020511443A5 (https=) 2021-04-08
JP7220664B2 true JP7220664B2 (ja) 2023-02-10

Family

ID=58261542

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2019548458A Active JP7220664B2 (ja) 2017-03-06 2018-03-06 液体医薬組成物

Country Status (4)

Country Link
US (2) US11534403B2 (https=)
EP (2) EP3372241A1 (https=)
JP (1) JP7220664B2 (https=)
WO (1) WO2018162503A1 (https=)

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Publication number Priority date Publication date Assignee Title
WO2018119142A1 (en) 2016-12-21 2018-06-28 Amgen Inc. Anti-tnf alpha antibody formulations
US11608357B2 (en) 2018-08-28 2023-03-21 Arecor Limited Stabilized antibody protein solutions
GB201703063D0 (en) * 2017-02-24 2017-04-12 Arecor Ltd 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
CN113727730A (zh) * 2019-03-18 2021-11-30 阿尔沃科技Hf公司 高浓度TNFα抗体的含水制剂
CA3211539A1 (en) * 2021-03-11 2022-09-15 Boris Schwartsburd Liquid formulations comprising mutant fgf-21 peptide pegylated conjugates
CN117120070B (zh) * 2021-03-11 2024-11-15 89生物公司 包含突变型fgf-21肽peg化缀合物的液体制剂
EP4400116A4 (en) * 2021-09-16 2025-09-24 Aprogen Inc PHARMACEUTICAL COMPOSITION CONTAINING AN ANTI-TNF ALPHA ANTIBODY

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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
JP2014524748A (ja) 2011-07-19 2014-09-25 グラクソ グループ リミテッド ＦｃＲｎ結合の増加したＴＮＦ−α抗原結合タンパク質
JP2015509526A (ja) 2012-03-07 2015-03-30 カディラ ヘルスケア リミティド 医薬製剤
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
JP2016505633A (ja) 2013-01-24 2016-02-25 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、ディベロップメント、リミテッドＧｌａｘｏｓｍｉｔｈｋｌｉｎｅ Ｉｎｔｅｌｌｅｃｔｕａｌ Ｐｒｏｐｅｒｔｙ Ｄｅｖｅｌｏｐｍｅｎｔ Ｌｉｍｉｔｅｄ ＴＮＦα抗原結合性タンパク質
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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ME00673B (me) 2000-05-15 2011-12-20 Hoffmann La Roche Nova farmaceutska smjesa
IL161677A0 (en) 2001-11-08 2004-09-27 Protein Design Labs Stable liquid pharmaceutical formulation of igg antibodies
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CN1703233A (zh) 2002-07-12 2005-11-30 米德列斯公司 防止蛋白氧化降解的方法和组合物
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US11608357B2 (en) 2018-08-28 2023-03-21 Arecor Limited Stabilized antibody protein solutions
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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
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Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010505852A (ja) 2006-10-06 2010-02-25 アムジエン・インコーポレーテツド 安定な抗体製剤
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
JP2014524748A (ja) 2011-07-19 2014-09-25 グラクソ グループ リミテッド ＦｃＲｎ結合の増加したＴＮＦ−α抗原結合タンパク質
JP2015509526A (ja) 2012-03-07 2015-03-30 カディラ ヘルスケア リミティド 医薬製剤
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
JP2016505633A (ja) 2013-01-24 2016-02-25 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、ディベロップメント、リミテッドＧｌａｘｏｓｍｉｔｈｋｌｉｎｅ Ｉｎｔｅｌｌｅｃｔｕａｌ Ｐｒｏｐｅｒｔｙ Ｄｅｖｅｌｏｐｍｅｎｔ Ｌｉｍｉｔｅｄ ＴＮＦα抗原結合性タンパク質
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

Also Published As

Publication number Publication date
EP3592385A1 (en) 2020-01-15
JP2020511443A (ja) 2020-04-16
EP3372241A1 (en) 2018-09-12
US20200016075A1 (en) 2020-01-16
US11534403B2 (en) 2022-12-27
WO2018162503A1 (en) 2018-09-13
EP3592385B1 (en) 2022-05-04
US20230233463A1 (en) 2023-07-27

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