JP2017516847A - 液体医薬組成物 - Google Patents

液体医薬組成物 Download PDF

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Publication number
JP2017516847A
JP2017516847A JP2017513323A JP2017513323A JP2017516847A JP 2017516847 A JP2017516847 A JP 2017516847A JP 2017513323 A JP2017513323 A JP 2017513323A JP 2017513323 A JP2017513323 A JP 2017513323A JP 2017516847 A JP2017516847 A JP 2017516847A
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suitably
histidine
pharmaceutical composition
liquid pharmaceutical
adalimumab
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Japanese (ja)
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JP2017516847A5 (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
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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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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 JP2017516847A publication Critical patent/JP2017516847A/ja
Publication of JP2017516847A5 publication Critical patent/JP2017516847A5/ja
Priority to JP2019187090A priority Critical patent/JP6962984B2/ja
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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
    • 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
    • A61K38/00—Medicinal preparations containing peptides
    • 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
    • A61K47/26—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
    • 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
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A61P27/14—Decongestants or antiallergics
    • 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
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding

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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)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Dermatology (AREA)
  • Rheumatology (AREA)
  • Mycology (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Genetics & Genomics (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Transplantation (AREA)
  • Hematology (AREA)
  • Inorganic Chemistry (AREA)
  • Diabetes (AREA)
  • Ophthalmology & Optometry (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2017513323A 2014-05-23 2015-05-15 液体医薬組成物 Withdrawn JP2017516847A (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2019187090A JP6962984B2 (ja) 2014-05-23 2019-10-10 液体医薬組成物

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP14169754.0A EP2946766B1 (en) 2014-05-23 2014-05-23 Liquid pharmaceutical composition
EP14169754.0 2014-05-23
PCT/EP2015/060817 WO2015177058A1 (en) 2014-05-23 2015-05-15 Liquid pharmaceutical composition

Related Child Applications (1)

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JP2019187090A Division JP6962984B2 (ja) 2014-05-23 2019-10-10 液体医薬組成物

Publications (2)

Publication Number Publication Date
JP2017516847A true JP2017516847A (ja) 2017-06-22
JP2017516847A5 JP2017516847A5 (enExample) 2018-06-28

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JP2017513323A Withdrawn JP2017516847A (ja) 2014-05-23 2015-05-15 液体医薬組成物
JP2019187090A Active JP6962984B2 (ja) 2014-05-23 2019-10-10 液体医薬組成物
JP2021167297A Pending JP2022003091A (ja) 2014-05-23 2021-10-12 液体医薬組成物

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JP2019187090A Active JP6962984B2 (ja) 2014-05-23 2019-10-10 液体医薬組成物
JP2021167297A Pending JP2022003091A (ja) 2014-05-23 2021-10-12 液体医薬組成物

Country Status (21)

Country Link
US (5) US10493152B2 (enExample)
EP (6) EP2946766B1 (enExample)
JP (3) JP2017516847A (enExample)
CN (2) CN108785670A (enExample)
AU (4) AU2015263246B2 (enExample)
CA (2) CA3050875A1 (enExample)
CY (1) CY1120488T1 (enExample)
DE (2) DE25179059T1 (enExample)
DK (3) DK3148510T3 (enExample)
ES (5) ES2572919T3 (enExample)
HK (1) HK1257026A1 (enExample)
HR (1) HRP20181226T1 (enExample)
HU (1) HUE040097T2 (enExample)
IL (1) IL249117B2 (enExample)
LT (1) LT3148510T (enExample)
PL (1) PL3148510T3 (enExample)
PT (1) PT3148510T (enExample)
RS (1) RS57772B1 (enExample)
SI (1) SI3148510T1 (enExample)
SM (1) SMT201800413T1 (enExample)
WO (1) WO2015177058A1 (enExample)

Cited By (1)

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WO2020138517A1 (ko) * 2018-12-24 2020-07-02 삼성바이오에피스 주식회사 항-TNFα 항체를 포함하는 약제학적 조성물

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EP2946767B1 (en) 2014-05-23 2016-10-05 Ares Trading S.A. Liquid pharmaceutical composition
PL2946765T3 (pl) 2014-05-23 2017-08-31 Ares Trading S.A. Ciekła kompozycja farmaceutyczna
EP2946766B1 (en) 2014-05-23 2016-03-02 Ares Trading S.A. Liquid pharmaceutical composition
EP3824906A1 (en) 2016-12-21 2021-05-26 Amgen Inc. Anti-tnf alpha antibody formulations
EP3459527B1 (en) * 2017-09-20 2022-11-23 Tillotts Pharma Ag Method for preparing a solid dosage form comprising antibodies by wet granulation, extrusion and spheronization
RU2020131642A (ru) * 2018-03-29 2022-04-29 Эйрвэй Терапьютикс, Инк. Способы и композиции, содержащие сурфактантный белок d (sp-d)
MX2020010031A (es) 2018-03-29 2021-01-08 Airway Therapeutics Inc Sistemas y metodos para caracterizar oligomeros de proteina surfactante d (sp-d).
AU2020207124A1 (en) * 2019-01-11 2021-07-29 Samsung Bioepis Co., Ltd. Pharmaceutical composition comprising antibody, device comprising same, and use thereof
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
CN115429751B (zh) * 2022-09-21 2023-11-17 景泽生物医药(合肥)股份有限公司 一种人重组卵泡刺激素注射剂及其制备方法
WO2025038671A2 (en) * 2023-08-15 2025-02-20 Amgen Inc. Acidic buffered intravenous solution stabilizers for use in methods of treatment

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EP2946766B1 (en) * 2014-05-23 2016-03-02 Ares Trading S.A. Liquid pharmaceutical composition
EP2946767B1 (en) 2014-05-23 2016-10-05 Ares Trading S.A. Liquid pharmaceutical composition
PL2946765T3 (pl) 2014-05-23 2017-08-31 Ares Trading S.A. Ciekła kompozycja farmaceutyczna
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Patent Citations (7)

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Publication number Priority date Publication date Assignee Title
JPS6388197A (ja) * 1986-09-30 1988-04-19 Tosoh Corp モノクロナル抗体の安定化方法
JP2007524602A (ja) * 2003-04-04 2007-08-30 ジェネンテック・インコーポレーテッド 高濃度抗体及びタンパク質製剤
JP2008507554A (ja) * 2004-07-23 2008-03-13 ジェネンテック・インコーポレーテッド 抗体又はその断片の結晶化
WO2013164837A1 (en) * 2012-03-07 2013-11-07 Cadila Healthcare Limited Pharmaceutical formulations of tnf-alpha antibodies
WO2013186230A1 (en) * 2012-06-12 2013-12-19 Boehringer Ingelheim International Gmbh Pharmaceutical formulation for a therapeutic antibody
WO2014039903A2 (en) * 2012-09-07 2014-03-13 Coherus Biosciences, Inc. Stable aqueous formulations of adalimumab
WO2014068026A1 (en) * 2012-10-31 2014-05-08 Amgen Research (Munich) Gmbh Liquid formulation comprising gm-csf neutralizing compound

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020138517A1 (ko) * 2018-12-24 2020-07-02 삼성바이오에피스 주식회사 항-TNFα 항체를 포함하는 약제학적 조성물

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ES3053508T2 (en) 2026-01-22
EP4249060A3 (en) 2024-01-03
CA2947487A1 (en) 2015-11-26
US12109267B2 (en) 2024-10-08
EP3659582B1 (en) 2023-08-16
AU2015263246A1 (en) 2016-11-17
EP2946766B1 (en) 2016-03-02
EP3403646A1 (en) 2018-11-21
US11752208B2 (en) 2023-09-12
PT3148510T (pt) 2018-09-28
DK3148510T3 (en) 2018-07-16
CN108785670A (zh) 2018-11-13
AU2022203863A1 (en) 2022-06-23
EP3148510B1 (en) 2018-06-27
SI3148510T1 (sl) 2018-10-30
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DK201800071Y4 (da) 2018-12-13
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EP4249060A2 (en) 2023-09-27
JP2022003091A (ja) 2022-01-11
AU2015263246B2 (en) 2018-06-21
JP6962984B2 (ja) 2021-11-05
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