JP2017516848A - 液体医薬組成物 - Google Patents

液体医薬組成物 Download PDF

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Publication number
JP2017516848A
JP2017516848A JP2017513324A JP2017513324A JP2017516848A JP 2017516848 A JP2017516848 A JP 2017516848A JP 2017513324 A JP2017513324 A JP 2017513324A JP 2017513324 A JP2017513324 A JP 2017513324A JP 2017516848 A JP2017516848 A JP 2017516848A
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Japan
Prior art keywords
suitably
pharmaceutical composition
liquid pharmaceutical
adalimumab
buffer
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Japanese (ja)
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JP2017516848A5 (cg-RX-API-DMAC7.html
Inventor
リナルディ ジャンルカ
リナルディ ジャンルカ
フラタルカンジェリ シルビア
フラタルカンジェリ シルビア
デル リオ アレッサンドラ
デル リオ アレッサンドラ
Original Assignee
アレス トレーディング ソシエテ アノニム
アレス トレーディング ソシエテ アノニム
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=50774706&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=JP2017516848(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by アレス トレーディング ソシエテ アノニム, アレス トレーディング ソシエテ アノニム filed Critical アレス トレーディング ソシエテ アノニム
Publication of JP2017516848A publication Critical patent/JP2017516848A/ja
Publication of JP2017516848A5 publication Critical patent/JP2017516848A5/ja
Priority to JP2021055560A priority Critical patent/JP2021107399A/ja
Priority to JP2022130994A priority patent/JP2022174082A/ja
Withdrawn legal-status Critical Current

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    • 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
    • A61K47/12—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
    • A61K47/26—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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • 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
    • 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
    • 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
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241—Tumor Necrosis Factors
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • 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
    • C07K2317/90—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

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)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Rheumatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Transplantation (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Hydrogenated Pyridines (AREA)
JP2017513324A 2014-05-23 2015-05-15 液体医薬組成物 Withdrawn JP2017516848A (ja)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2021055560A JP2021107399A (ja) 2014-05-23 2021-03-29 液体医薬組成物
JP2022130994A JP2022174082A (ja) 2014-05-23 2022-08-19 液体医薬組成物

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP14169755.7 2014-05-23
EP14169755.7A EP2946767B1 (en) 2014-05-23 2014-05-23 Liquid pharmaceutical composition
PCT/EP2015/060818 WO2015177059A1 (en) 2014-05-23 2015-05-15 Liquid pharmaceutical composition

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2021055560A Division JP2021107399A (ja) 2014-05-23 2021-03-29 液体医薬組成物

Publications (2)

Publication Number Publication Date
JP2017516848A true JP2017516848A (ja) 2017-06-22
JP2017516848A5 JP2017516848A5 (cg-RX-API-DMAC7.html) 2018-06-21

Family

ID=50774706

Family Applications (3)

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JP2017513324A Withdrawn JP2017516848A (ja) 2014-05-23 2015-05-15 液体医薬組成物
JP2021055560A Withdrawn JP2021107399A (ja) 2014-05-23 2021-03-29 液体医薬組成物
JP2022130994A Pending JP2022174082A (ja) 2014-05-23 2022-08-19 液体医薬組成物

Family Applications After (2)

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JP2021055560A Withdrawn JP2021107399A (ja) 2014-05-23 2021-03-29 液体医薬組成物
JP2022130994A Pending JP2022174082A (ja) 2014-05-23 2022-08-19 液体医薬組成物

Country Status (19)

Country Link
US (2) US10426833B2 (cg-RX-API-DMAC7.html)
EP (4) EP2946767B1 (cg-RX-API-DMAC7.html)
JP (3) JP2017516848A (cg-RX-API-DMAC7.html)
CN (2) CN106535935A (cg-RX-API-DMAC7.html)
AU (3) AU2015263247A1 (cg-RX-API-DMAC7.html)
CA (2) CA2948746C (cg-RX-API-DMAC7.html)
CY (1) CY1124493T1 (cg-RX-API-DMAC7.html)
DK (3) DK3145488T3 (cg-RX-API-DMAC7.html)
ES (2) ES2607489T3 (cg-RX-API-DMAC7.html)
HK (1) HK1231391A1 (cg-RX-API-DMAC7.html)
HR (1) HRP20201242T1 (cg-RX-API-DMAC7.html)
HU (1) HUE050779T2 (cg-RX-API-DMAC7.html)
IL (2) IL277241B (cg-RX-API-DMAC7.html)
LT (1) LT3145488T (cg-RX-API-DMAC7.html)
PT (1) PT3145488T (cg-RX-API-DMAC7.html)
RS (1) RS60801B1 (cg-RX-API-DMAC7.html)
SI (1) SI3145488T1 (cg-RX-API-DMAC7.html)
SM (1) SMT202000479T1 (cg-RX-API-DMAC7.html)
WO (1) WO2015177059A1 (cg-RX-API-DMAC7.html)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2021531346A (ja) * 2018-07-20 2021-11-18 モメンタ ファーマシューティカルズ インコーポレイテッド Ｆｃｒｎ抗体の組成物およびその使用の方法
JP2023510928A (ja) * 2020-01-20 2023-03-15 上海君▲実▼生物医▲薬▼科技股▲分▼有限公司 抗ｂｔｌａ抗体医薬組成物及びその使用

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ES2600488T3 (es) 2014-05-23 2017-02-09 Ares Trading S.A. Composición farmacéutica líquida
EP2946766B1 (en) 2014-05-23 2016-03-02 Ares Trading S.A. Liquid pharmaceutical composition
CN105543204A (zh) * 2015-12-30 2016-05-04 海口奇力制药股份有限公司 一种组合物及其应用、含有该组合物的稳定剂
WO2017177160A1 (en) 2016-04-07 2017-10-12 Nevakar Llc Formulation for use in a method of treatment of pain
EP4467565A3 (en) 2016-12-21 2025-03-12 Amgen Inc. Anti-tnf alpha antibody formulations
BR112019021723A2 (pt) * 2017-04-18 2021-06-29 Dr. Reddy's Laboratories Limited formulação de anticorpo líquida estável, anticorpo na formulação, formulação líquida estável de anticorpo anti-il6r, formulação líquida estável de tocilizumab em sistema de tampão de fosfato-aminoácido, e, formulação líquida estável de tocilizumab
CN111432882A (zh) * 2017-10-03 2020-07-17 内瓦卡公司 对乙酰氨基酚-普瑞巴林组合和治疗疼痛的方法
MX2017016884A (es) * 2017-12-19 2019-06-20 Probiomed S A De C V Formulacion farmaceutica estable de una proteina anti-tnfa.
IL319755A (en) * 2022-10-07 2025-05-01 Annexon Inc Anti-C1Q antibody formulations

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JP2012507553A (ja) * 2008-10-29 2012-03-29 ワイス・エルエルシー 単一ドメイン抗原結合分子の製剤
JP2012526121A (ja) * 2009-05-04 2012-10-25 アボツト・バイオテクノロジー・リミテツド ヒト抗ｔｎｆアルファ抗体の安定した高蛋白質濃度製剤
WO2013164837A1 (en) * 2012-03-07 2013-11-07 Cadila Healthcare Limited Pharmaceutical formulations of tnf-alpha antibodies
WO2014039903A2 (en) * 2012-09-07 2014-03-13 Coherus Biosciences, Inc. Stable aqueous formulations of adalimumab

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2021531346A (ja) * 2018-07-20 2021-11-18 モメンタ ファーマシューティカルズ インコーポレイテッド Ｆｃｒｎ抗体の組成物およびその使用の方法
JP7457704B2 (ja) 2018-07-20 2024-03-28 モメンタ ファーマシューティカルズ インコーポレイテッド Ｆｃｒｎ抗体の組成物およびその使用の方法
JP2023510928A (ja) * 2020-01-20 2023-03-15 上海君▲実▼生物医▲薬▼科技股▲分▼有限公司 抗ｂｔｌａ抗体医薬組成物及びその使用
JP7785677B2 (ja) 2020-01-20 2025-12-15 上海君▲実▼生物医▲薬▼科技股▲分▼有限公司 抗ｂｔｌａ抗体医薬組成物及びその使用

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EP3145488A1 (en) 2017-03-29
HUE050779T2 (hu) 2021-01-28
EP2946767B1 (en) 2016-10-05
IL249116B (en) 2020-09-30
DK202000030U1 (da) 2020-04-28
US20170182162A1 (en) 2017-06-29
DK202000038Y3 (da) 2020-07-10
EP3741358A1 (en) 2020-11-25
CN111939257A (zh) 2020-11-17
SI3145488T1 (sl) 2020-10-30
AU2015263247A1 (en) 2016-12-01
IL277241A (en) 2020-10-29
ES2607489T3 (es) 2017-03-31
JP2022174082A (ja) 2022-11-22
HRP20201242T1 (hr) 2020-11-13
AU2020286276A1 (en) 2021-01-14
EP2946767A1 (en) 2015-11-25
CA3104940A1 (en) 2015-11-26
CN106535935A (zh) 2017-03-22
AU2020204269A1 (en) 2020-07-16
EP3939566A1 (en) 2022-01-19
WO2015177059A1 (en) 2015-11-26
DK202000038U1 (da) 2020-05-18
CA2948746A1 (en) 2015-11-26
US20200155677A1 (en) 2020-05-21
RS60801B1 (sr) 2020-10-30
DK202000030Y3 (da) 2020-05-26
AU2020286276B2 (en) 2023-06-01
DK3145488T3 (da) 2020-08-10
SMT202000479T1 (it) 2020-11-10
HK1231391A1 (zh) 2017-12-22
CY1124493T1 (el) 2022-03-24
CA2948746C (en) 2021-01-12
LT3145488T (lt) 2020-11-25
AU2020204269B2 (en) 2020-09-17
US10426833B2 (en) 2019-10-01
ES2815598T3 (es) 2021-03-30
IL277241B (en) 2022-08-01
EP3145488B1 (en) 2020-07-22
JP2021107399A (ja) 2021-07-29
PT3145488T (pt) 2020-09-01
IL249116A0 (en) 2017-01-31

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