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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JP
Japan
Prior art keywords
suitably
pharmaceutical composition
liquid pharmaceutical
adalimumab
buffer
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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.)
Withdrawn
Application number
JP2017513324A
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English (en)
Japanese (ja)
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JP2017516848A5 (enExample
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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Family has litigation
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Withdrawn legal-status Critical Current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)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Rheumatology (AREA)
  • Transplantation (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Pain & Pain Management (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 (enExample) 2018-06-21

Family

ID=50774706

Family Applications (3)

Application Number Title Priority Date Filing Date
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)

Application Number Title Priority Date Filing Date
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 (enExample)
EP (4) EP2946767B1 (enExample)
JP (3) JP2017516848A (enExample)
CN (2) CN111939257A (enExample)
AU (3) AU2015263247A1 (enExample)
CA (2) CA2948746C (enExample)
CY (1) CY1124493T1 (enExample)
DK (3) DK3145488T3 (enExample)
ES (2) ES2607489T3 (enExample)
HK (1) HK1231391A1 (enExample)
HR (1) HRP20201242T1 (enExample)
HU (1) HUE050779T2 (enExample)
IL (2) IL277241B (enExample)
LT (1) LT3145488T (enExample)
PT (1) PT3145488T (enExample)
RS (1) RS60801B1 (enExample)
SI (1) SI3145488T1 (enExample)
SM (1) SMT202000479T1 (enExample)
WO (1) WO2015177059A1 (enExample)

Cited By (3)

* 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
US12528867B2 (en) 2019-07-19 2026-01-20 Momenta Pharmaceuticals, Inc. FCRN antibody compositions

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LT2946765T (lt) 2014-05-23 2016-11-25 Ares Trading S.A. Skysta farmacinė kompozicija
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
US10052296B2 (en) 2016-04-07 2018-08-21 Nevakar Inc. Formulations for treating pain
EP3824906A1 (en) 2016-12-21 2021-05-26 Amgen Inc. Anti-tnf alpha antibody formulations
WO2018193471A1 (en) * 2017-04-18 2018-10-25 Dr. Reddy's Laboratories Limited Stable liquid pharmaceutical composition
CA3075414A1 (en) * 2017-10-03 2019-04-11 Nevakar Inc. Acetaminophen-pregabalin combinations and methods of treating pain
MX2017016884A (es) * 2017-12-19 2019-06-20 Probiomed S A De C V Formulacion farmaceutica estable de una proteina anti-tnfa.
AU2023355926A1 (en) * 2022-10-07 2025-04-03 Annexon, Inc. Formulations for anti-c1q antibodies

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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

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EP2727602A1 (en) 2012-10-31 2014-05-07 Takeda GmbH Method for preparation of a high concentration liquid formulation of an antibody
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EP2946766B1 (en) 2014-05-23 2016-03-02 Ares Trading S.A. Liquid pharmaceutical composition
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Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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 (5)

* 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
US12528867B2 (en) 2019-07-19 2026-01-20 Momenta Pharmaceuticals, Inc. FCRN antibody compositions
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

Also Published As

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

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