JP2019536761A - 液体医薬組成物 - Google Patents

液体医薬組成物 Download PDF

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Publication number
JP2019536761A
JP2019536761A JP2019522329A JP2019522329A JP2019536761A JP 2019536761 A JP2019536761 A JP 2019536761A JP 2019522329 A JP2019522329 A JP 2019522329A JP 2019522329 A JP2019522329 A JP 2019522329A JP 2019536761 A JP2019536761 A JP 2019536761A
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JP
Japan
Prior art keywords
pharmaceutical composition
liquid pharmaceutical
tocilizumab
concentration
salt
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
JP2019522329A
Other languages
English (en)
Japanese (ja)
Other versions
JP2019536761A5 (enExample
Inventor
イエジェク，ヤン
バディアリ，ルカ
ジェリング，デイビッド
Original Assignee
フレゼニウス カービ ドイチュラント ゲーエムベーハー
フレゼニウス カービ ドイチュラント ゲーエムベーハー
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by フレゼニウス カービ ドイチュラント ゲーエムベーハー, フレゼニウス カービ ドイチュラント ゲーエムベーハー filed Critical フレゼニウス カービ ドイチュラント ゲーエムベーハー
Publication of JP2019536761A publication Critical patent/JP2019536761A/ja
Publication of JP2019536761A5 publication Critical patent/JP2019536761A5/ja
Priority to JP2022117520A priority Critical patent/JP7473603B2/ja
Pending legal-status Critical Current

Links

Classifications

    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • 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
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

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)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Rheumatology (AREA)
  • Inorganic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (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)
JP2019522329A 2016-10-31 2017-10-30 液体医薬組成物 Pending JP2019536761A (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2022117520A JP7473603B2 (ja) 2016-10-31 2022-07-22 液体医薬組成物

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP16196625 2016-10-31
EP16196625.4 2016-10-31
PCT/EP2017/077793 WO2018078162A1 (en) 2016-10-31 2017-10-30 Liquid pharmaceutical composition

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2022117520A Division JP7473603B2 (ja) 2016-10-31 2022-07-22 液体医薬組成物

Publications (2)

Publication Number Publication Date
JP2019536761A true JP2019536761A (ja) 2019-12-19
JP2019536761A5 JP2019536761A5 (enExample) 2020-08-20

Family

ID=57218780

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2019522329A Pending JP2019536761A (ja) 2016-10-31 2017-10-30 液体医薬組成物
JP2022117520A Active JP7473603B2 (ja) 2016-10-31 2022-07-22 液体医薬組成物

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2022117520A Active JP7473603B2 (ja) 2016-10-31 2022-07-22 液体医薬組成物

Country Status (16)

Country Link
US (2) US11291725B2 (enExample)
EP (2) EP3532029B1 (enExample)
JP (2) JP2019536761A (enExample)
KR (1) KR20190078572A (enExample)
CN (1) CN110062620B (enExample)
AU (1) AU2017351805A1 (enExample)
BR (1) BR112019006853B1 (enExample)
CA (1) CA3040342A1 (enExample)
DK (1) DK3532029T3 (enExample)
ES (1) ES2882181T3 (enExample)
HU (1) HUE054858T2 (enExample)
MY (1) MY192532A (enExample)
RU (1) RU2019116756A (enExample)
SG (1) SG11201902531QA (enExample)
WO (1) WO2018078162A1 (enExample)
ZA (1) ZA201901736B (enExample)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2022166006A (ja) * 2016-10-31 2022-11-01 フレゼニウス カービ ドイチュラント ゲーエムベーハー 液体医薬組成物
JP2023540072A (ja) * 2020-08-31 2023-09-21 セルトリオン インク 安定した薬剤学的製剤
JP2024516293A (ja) * 2021-05-07 2024-04-12 ドクター レディズ ラボラトリーズ リミテッド 抗体製剤の安定性を向上させる方法

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PE20091174A1 (es) 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
EP3824906A1 (en) 2016-12-21 2021-05-26 Amgen Inc. Anti-tnf alpha antibody formulations
WO2020088346A1 (en) * 2018-10-31 2020-05-07 Mycenax Biotech Inc. Aqueous pharmaceutical formulations
EP4072512A4 (en) * 2019-12-10 2024-01-10 Mitotech S.A. POLYMER MATRICES FOR VARIOUS COMPOSITIONS OF MITOCHONDRIALLY DIRECTED ANTIOXIDANTS
JP2023517611A (ja) * 2020-03-10 2023-04-26 ティジアーナ ライフ サイエンシズ パブリック リミティド カンパニー Ｉｌ－６／ｉｌ－６ｒ抗体の組成物及びその使用方法
EP3714902B1 (en) * 2020-03-13 2024-08-28 LEK Pharmaceuticals d.d. Stabilization of pharmaceutical compositions comprising polysorbate
WO2022006051A1 (en) * 2020-06-29 2022-01-06 Anovent Pharmaceutical (U.S.), Llc Formulation of tocilizumab and method for treating covid-19 by inhalation
US20230090654A1 (en) * 2021-08-24 2023-03-23 Homology Medicines, Inc. Adeno-associated virus formulations
KR20250075749A (ko) * 2022-08-26 2025-05-28 아슬란 파마슈티컬스 피티이 엘티디 항-il13r 항체의 고농도 제형
KR102554775B1 (ko) 2023-02-07 2023-07-12 한국코러스 주식회사 히알루로니다제의 안정화제 및 이를 포함하는 히알루로니다제 제형
WO2024257040A1 (en) * 2023-06-14 2024-12-19 Enzene Biosciences Limited Composition and stable liquid formulations comprising humanized anti-human interleukin 6 (il-6) receptor monoclonal antibodies

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009034095A (ja) * 2007-07-06 2009-02-19 Sanyo Chem Ind Ltd タンパク質含有水溶液安定化剤、タンパク質含有水溶液の安定化方法及びタンパク質含有水溶液
JP2013541594A (ja) * 2010-11-08 2013-11-14 ジェネンテック， インコーポレイテッド 皮下投与される抗ｉｌ−６受容体抗体

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU668349B2 (en) 1991-04-25 1996-05-02 Chugai Seiyaku Kabushiki Kaisha Reconstituted human antibody against human interleukin 6 receptor
US8632778B2 (en) 2000-08-11 2014-01-21 Chugai Seiyaku Kabushiki Kaisha Stabilized anti-interleukin-6 antibody-containing preparations
WO2003068260A1 (fr) 2002-02-14 2003-08-21 Chugai Seiyaku Kabushiki Kaisha Produits pharmaceutiques en solution contenant des anticorps
GB0700523D0 (en) * 2007-01-11 2007-02-21 Insense Ltd The Stabilisation Of Proteins
UA100245C2 (uk) * 2007-08-27 2012-12-10 Біогенерікс Аг Рідка форма г-ксф
PE20091174A1 (es) 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
JO3417B1 (ar) 2010-01-08 2019-10-20 Regeneron Pharma الصيغ المستقرة التي تحتوي على الأجسام المضادة لمضاد مستقبل( interleukin-6 (il-6r
AU2012328524B2 (en) 2011-10-28 2017-05-18 Excelse Bio, Inc. Protein formulations containing amino acids
CN104520326A (zh) * 2012-06-21 2015-04-15 Ucb医药有限公司 药物制剂
CN102961745B (zh) * 2012-09-27 2015-02-18 苏州康聚生物科技有限公司 抗体组合物制剂及其应用
BR112019006853B1 (pt) * 2016-10-31 2021-08-24 Fresenius Kabi Deutschland Gmbh Composição farmacêutica líquida, seu método de fabricação, seu uso, kit e dispositivo de liberação de fármaco que a compreendem e método de fabricação do dito dispositivo

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009034095A (ja) * 2007-07-06 2009-02-19 Sanyo Chem Ind Ltd タンパク質含有水溶液安定化剤、タンパク質含有水溶液の安定化方法及びタンパク質含有水溶液
JP2013541594A (ja) * 2010-11-08 2013-11-14 ジェネンテック， インコーポレイテッド 皮下投与される抗ｉｌ−６受容体抗体

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2022166006A (ja) * 2016-10-31 2022-11-01 フレゼニウス カービ ドイチュラント ゲーエムベーハー 液体医薬組成物
JP2023540072A (ja) * 2020-08-31 2023-09-21 セルトリオン インク 安定した薬剤学的製剤
JP2024516293A (ja) * 2021-05-07 2024-04-12 ドクター レディズ ラボラトリーズ リミテッド 抗体製剤の安定性を向上させる方法

Also Published As

Publication number Publication date
US20190262450A1 (en) 2019-08-29
BR112019006853A2 (pt) 2019-06-25
RU2019116756A (ru) 2020-11-30
WO2018078162A1 (en) 2018-05-03
CA3040342A1 (en) 2018-05-03
US20220175924A1 (en) 2022-06-09
EP3532029B1 (en) 2021-04-28
AU2017351805A1 (en) 2019-04-11
CN110062620A (zh) 2019-07-26
DK3532029T3 (da) 2021-06-07
EP3964197A1 (en) 2022-03-09
RU2019116756A3 (enExample) 2021-02-26
US11291725B2 (en) 2022-04-05
KR20190078572A (ko) 2019-07-04
ES2882181T3 (es) 2021-12-01
MY192532A (en) 2022-08-26
EP3532029A1 (en) 2019-09-04
SG11201902531QA (en) 2019-05-30
CN110062620B (zh) 2023-12-05
JP7473603B2 (ja) 2024-04-23
JP2022166006A (ja) 2022-11-01
ZA201901736B (en) 2020-11-25
BR112019006853B1 (pt) 2021-08-24
HUE054858T2 (hu) 2021-10-28

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