JP2019534863A - 液体医薬組成物 - Google Patents

液体医薬組成物 Download PDF

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Publication number
JP2019534863A
JP2019534863A JP2019515630A JP2019515630A JP2019534863A JP 2019534863 A JP2019534863 A JP 2019534863A JP 2019515630 A JP2019515630 A JP 2019515630A JP 2019515630 A JP2019515630 A JP 2019515630A JP 2019534863 A JP2019534863 A JP 2019534863A
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Prior art keywords
pharmaceutical composition
liquid pharmaceutical
antibody
concentration
buffer
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Pending
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JP2019515630A
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Japanese (ja)
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JP2019534863A5 (https=
Inventor
リオ，アレッサンドラ デル
リオ，アレッサンドラ デル
サビーナ，カルメラ
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
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Publication of JP2019534863A publication Critical patent/JP2019534863A/ja
Publication of JP2019534863A5 publication Critical patent/JP2019534863A5/ja
Priority to JP2022146770A priority Critical patent/JP2022188075A/ja
Priority to JP2024148123A priority patent/JP2024178197A/ja
Pending legal-status Critical Current

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    • 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
    • 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
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K47/16—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
    • A61K9/0012—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
    • 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
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A61P21/02—Muscle relaxants, e.g. for tetanus or cramps
    • 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
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • 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
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/569—Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody®
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Rheumatology (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Inorganic Chemistry (AREA)
  • Endocrinology (AREA)
  • Neurology (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
JP2019515630A 2016-09-27 2017-09-26 液体医薬組成物 Pending JP2019534863A (ja)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2022146770A JP2022188075A (ja) 2016-09-27 2022-09-15 液体医薬組成物
JP2024148123A JP2024178197A (ja) 2016-09-27 2024-08-30 液体医薬組成物

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP16190957 2016-09-27
EP16190957.7 2016-09-27
PCT/EP2017/074413 WO2018060210A1 (en) 2016-09-27 2017-09-26 Liquid pharmaceutical composition

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2022146770A Division JP2022188075A (ja) 2016-09-27 2022-09-15 液体医薬組成物

Publications (2)

Publication Number Publication Date
JP2019534863A true JP2019534863A (ja) 2019-12-05
JP2019534863A5 JP2019534863A5 (https=) 2020-08-20

Family

ID=57047015

Family Applications (3)

Application Number Title Priority Date Filing Date
JP2019515630A Pending JP2019534863A (ja) 2016-09-27 2017-09-26 液体医薬組成物
JP2022146770A Pending JP2022188075A (ja) 2016-09-27 2022-09-15 液体医薬組成物
JP2024148123A Pending JP2024178197A (ja) 2016-09-27 2024-08-30 液体医薬組成物

Family Applications After (2)

Application Number Title Priority Date Filing Date
JP2022146770A Pending JP2022188075A (ja) 2016-09-27 2022-09-15 液体医薬組成物
JP2024148123A Pending JP2024178197A (ja) 2016-09-27 2024-08-30 液体医薬組成物

Country Status (12)

Country Link
US (3) US10961314B2 (https=)
EP (1) EP3518891A1 (https=)
JP (3) JP2019534863A (https=)
KR (1) KR102546471B1 (https=)
CN (1) CN109862880A (https=)
AU (1) AU2017333367A1 (https=)
BR (1) BR112019005328A2 (https=)
CA (1) CA3037440A1 (https=)
MA (1) MA46334A (https=)
RU (1) RU2019112680A (https=)
WO (1) WO2018060210A1 (https=)
ZA (1) ZA201901590B (https=)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2023528068A (ja) * 2020-06-05 2023-07-03 ジョイント・ストック・カンパニー “バイオキャド” レビリマブの水性医薬組成物
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
JP2024178197A (ja) * 2016-09-27 2024-12-24 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

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PE20091174A1 (es) 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
KR20190120439A (ko) 2010-11-08 2019-10-23 제넨테크, 인크. 피하 투여용 항―ｉｌ―6 수용체 항체
WO2018119142A1 (en) 2016-12-21 2018-06-28 Amgen Inc. Anti-tnf alpha antibody formulations
RU2020121415A (ru) * 2017-11-30 2021-12-30 Био-Тера Солюшнз, Лтд. Жидкий препарат гуманизированного антитела для лечения заболеваний, опосредованных ил-6
US11427639B2 (en) * 2018-04-02 2022-08-30 Richter Gedeon Nyrt. Antibody-containing aqueous formulation and use thereof
MA54095A (fr) * 2018-10-31 2022-02-09 Richter Gedeon Nyrt Formulations pharmaceutiques aqueuses
WO2020160156A2 (en) 2019-01-30 2020-08-06 Immutics, Inc. Anti-gal3 antibodies and uses thereof
CN110179746A (zh) * 2019-05-17 2019-08-30 通化东宝生物科技有限公司 一种稳定的苏金单抗注射剂及其制备方法
EP3714902B1 (en) * 2020-03-13 2024-08-28 LEK Pharmaceuticals d.d. Stabilization of pharmaceutical compositions comprising polysorbate
CN113456582B (zh) * 2020-03-30 2024-06-14 鲁南制药集团股份有限公司 重组人源化抗pd-1单克隆抗体的液体制剂
CN115605184A (zh) * 2020-05-15 2023-01-13 豪夫迈·罗氏有限公司（Ch） 防止胃肠外蛋白质溶液中的可见颗粒形成
EP4157338A4 (en) * 2020-05-26 2024-11-13 TrueBinding, Inc. METHOD FOR TREATING INFLAMMATORY DISEASES BY GALECTIN-3 BLOCKING
WO2022006051A1 (en) * 2020-06-29 2022-01-06 Anovent Pharmaceutical (U.S.), Llc Formulation of tocilizumab and method for treating covid-19 by inhalation
CN116261448A (zh) * 2020-08-19 2023-06-13 百奥泰生物制药股份有限公司 用于治疗il-6相关疾病的包含高浓度人源化抗体的液体制剂
WO2022139457A1 (ko) * 2020-12-24 2022-06-30 이니스트에스티 주식회사 봉독 추출물로부터 bvPLA2를 50~99% 함량으로 포함하는 봉독 주사제 조성물 및 이의 제조방법
CN121240883A (zh) * 2023-05-26 2025-12-30 百奥泰生物制药股份有限公司 用于治疗il-6相关疾病的包含高浓度人源化抗体的液体制剂

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JP2012510468A (ja) * 2008-11-28 2012-05-10 アボット・ラボラトリーズ 安定な抗体組成物およびこれを安定させるための方法
JP2013516481A (ja) * 2010-01-08 2013-05-13 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 抗インターロイキン６受容体（ｉｌ−６ｒ）抗体を含有する安定化製剤
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
JP2015536934A (ja) * 2012-10-25 2015-12-24 メディミューン，エルエルシー 安定した低粘度の抗体製剤

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PE20091174A1 (es) 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
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CN116261448A (zh) * 2020-08-19 2023-06-13 百奥泰生物制药股份有限公司 用于治疗il-6相关疾病的包含高浓度人源化抗体的液体制剂
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JP2012510468A (ja) * 2008-11-28 2012-05-10 アボット・ラボラトリーズ 安定な抗体組成物およびこれを安定させるための方法
JP2013516481A (ja) * 2010-01-08 2013-05-13 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 抗インターロイキン６受容体（ｉｌ−６ｒ）抗体を含有する安定化製剤
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
JP2015536934A (ja) * 2012-10-25 2015-12-24 メディミューン，エルエルシー 安定した低粘度の抗体製剤

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2024178197A (ja) * 2016-09-27 2024-12-24 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
JP2023528068A (ja) * 2020-06-05 2023-07-03 ジョイント・ストック・カンパニー “バイオキャド” レビリマブの水性医薬組成物
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

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Publication number Publication date
US20240150479A1 (en) 2024-05-09
BR112019005328A2 (pt) 2019-06-18
RU2019112680A (ru) 2020-10-29
US10961314B2 (en) 2021-03-30
WO2018060210A1 (en) 2018-04-05
US20190218300A1 (en) 2019-07-18
AU2017333367A1 (en) 2019-04-04
CN109862880A (zh) 2019-06-07
JP2022188075A (ja) 2022-12-20
EP3518891A1 (en) 2019-08-07
JP2024178197A (ja) 2024-12-24
RU2019112680A3 (https=) 2020-12-15
CA3037440A1 (en) 2018-04-05
KR102546471B1 (ko) 2023-06-21
MA46334A (fr) 2019-08-07
ZA201901590B (en) 2020-10-28
KR20190062440A (ko) 2019-06-05
US20210261673A1 (en) 2021-08-26

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