JP7220664B2 - 液体医薬組成物 - Google Patents

液体医薬組成物 Download PDF

Info

Publication number
JP7220664B2
JP7220664B2 JP2019548458A JP2019548458A JP7220664B2 JP 7220664 B2 JP7220664 B2 JP 7220664B2 JP 2019548458 A JP2019548458 A JP 2019548458A JP 2019548458 A JP2019548458 A JP 2019548458A JP 7220664 B2 JP7220664 B2 JP 7220664B2
Authority
JP
Japan
Prior art keywords
liquid pharmaceutical
adalimumab
pharmaceutical composition
arginine
composition
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.)
Active
Application number
JP2019548458A
Other languages
English (en)
Japanese (ja)
Other versions
JP2020511443A5 (enExample
JP2020511443A (ja
Inventor
バディアリ ルカ
ジェリング デビッド
ジェゼク ジャン
Original Assignee
アレコル リミテッド
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 アレコル リミテッド filed Critical アレコル リミテッド
Publication of JP2020511443A publication Critical patent/JP2020511443A/ja
Publication of JP2020511443A5 publication Critical patent/JP2020511443A5/ja
Application granted granted Critical
Publication of JP7220664B2 publication Critical patent/JP7220664B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241Tumor Necrosis Factors
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man

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)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
JP2019548458A 2017-03-06 2018-03-06 液体医薬組成物 Active JP7220664B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP17159458.3 2017-03-06
EP17159458.3A EP3372241A1 (en) 2017-03-06 2017-03-06 Liquid pharmaceutical composition
PCT/EP2018/055509 WO2018162503A1 (en) 2017-03-06 2018-03-06 Liquid pharmaceutical composition

Publications (3)

Publication Number Publication Date
JP2020511443A JP2020511443A (ja) 2020-04-16
JP2020511443A5 JP2020511443A5 (enExample) 2021-04-08
JP7220664B2 true JP7220664B2 (ja) 2023-02-10

Family

ID=58261542

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2019548458A Active JP7220664B2 (ja) 2017-03-06 2018-03-06 液体医薬組成物

Country Status (4)

Country Link
US (2) US11534403B2 (enExample)
EP (2) EP3372241A1 (enExample)
JP (1) JP7220664B2 (enExample)
WO (1) WO2018162503A1 (enExample)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018119142A1 (en) 2016-12-21 2018-06-28 Amgen Inc. Anti-tnf alpha antibody formulations
GB201703063D0 (en) * 2017-02-24 2017-04-12 Arecor Ltd Stabilized antibody protein solutions
US11608357B2 (en) 2018-08-28 2023-03-21 Arecor Limited Stabilized antibody protein solutions
EP3372242A1 (en) 2017-03-06 2018-09-12 Ares Trading S.A. Liquid pharmaceutical composition
EP3372241A1 (en) 2017-03-06 2018-09-12 Ares Trading S.A. Liquid pharmaceutical composition
WO2020187760A1 (en) * 2019-03-18 2020-09-24 Alvotech Hf Aqueous formulations of tnf-alpha antibodies in high concentrations
CN117120070B (zh) * 2021-03-11 2024-11-15 89生物公司 包含突变型fgf-21肽peg化缀合物的液体制剂
CA3211539A1 (en) 2021-03-11 2022-09-15 Boris Schwartsburd Liquid formulations comprising mutant fgf-21 peptide pegylated conjugates
WO2023043232A1 (ko) * 2021-09-16 2023-03-23 주식회사 에이프로젠 항-TNFα 항체를 포함하는 약제학적 조성물

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010505852A (ja) 2006-10-06 2010-02-25 アムジエン・インコーポレーテツド 安定な抗体製剤
JP2010529999A (ja) 2007-06-14 2010-09-02 バイオジェン・アイデック・エムエイ・インコーポレイテッド 抗体製剤
JP2014524748A (ja) 2011-07-19 2014-09-25 グラクソ グループ リミテッド FcRn結合の増加したTNF−α抗原結合タンパク質
JP2015509526A (ja) 2012-03-07 2015-03-30 カディラ ヘルスケア リミティド 医薬製剤
JP2015527402A (ja) 2012-09-07 2015-09-17 コヒラス・バイオサイエンシズ・インコーポレイテッド 安定水性アダリムマブ製剤
JP2016505633A (ja) 2013-01-24 2016-02-25 グラクソスミスクライン、インテレクチュアル、プロパティー、ディベロップメント、リミテッドGlaxosmithkline Intellectual Property Development Limited TNFα抗原結合性タンパク質
JP2016117732A (ja) 2014-12-23 2016-06-30 ファイザー・インク 安定な水性抗体製剤

Family Cites Families (30)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BRPI9707379C8 (pt) 1996-02-09 2017-12-12 Abbott Biotech Ltd composições farmacêuticas compreendendo anticorpo humano recombinante geneticamente engenheirado, e anticorpo humano recombinante geneticamente engenheirado.
EP1525889A1 (en) 2000-05-15 2005-04-27 F. Hoffmann-La Roche Ag Liquid pharmaceutical composition containing an erythropoietin derivative
EP1441589B1 (en) 2001-11-08 2012-05-09 Abbott Biotherapeutics Corp. Stable liquid pharmaceutical formulation of igg antibodies
PL215168B1 (pl) 2002-02-27 2013-10-31 Immunex Corp Formulacja polipeptydowa
EP1539212A4 (en) 2002-07-12 2007-05-02 Medarex Inc METHOD AND COMPOSITIONS FOR PREVENTING OXIDATIVE DEGRADATION OF PROTEINS
US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
BRPI0606867A2 (pt) 2005-01-28 2009-07-21 Wyeth Corp formulação lìquida; forma de dosagem unitária farmacêutica; kit; recipiente; método para aumentar a estabilidade de um polipeptìdeo de ligação a antìgeno numa formulação; método para preparar uma forma de dosagem unitária farmacêutica; formulação estável; formulação; e produto terapêutico
NZ560844A (en) 2005-03-08 2008-08-29 Pharmacia & Upjohn Co Llc Anti-MAdCAM antibody compositions
TW200806317A (en) 2006-03-20 2008-02-01 Wyeth Corp Methods for reducing protein aggregation
US7705132B2 (en) 2006-10-20 2010-04-27 Amgen Inc. Stable polypeptide formulations
GB0700523D0 (en) 2007-01-11 2007-02-21 Insense Ltd The Stabilisation Of Proteins
PE20091174A1 (es) 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
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
WO2010129469A1 (en) * 2009-05-04 2010-11-11 Abbott Biotechnology Ltd. Stable high protein concentration formulations of human anti-tnf-alpha-antibodies
US20130209465A1 (en) 2010-07-30 2013-08-15 Arecor Ltd. Stabilized Aqueous Antibody Compositions
CN104998254A (zh) 2010-11-08 2015-10-28 基因技术公司 皮下施用的抗-il-6受体抗体
JP2015506369A (ja) 2012-01-30 2015-03-02 アレコー リミテッド 安定化された水性抗体組成物
HUP1400510A1 (hu) * 2014-10-28 2016-05-30 Richter Gedeon Nyrt Gyógyászati TNFalfa ellenes antitest készítmény
WO2016109822A1 (en) 2014-12-31 2016-07-07 Novelmed Therapeutics, Inc. Formulation of aglycosylated therapeutic antibodies
TW201636047A (zh) * 2015-01-28 2016-10-16 麥博賽恩斯有限公司 抗-TNF-α抗體之醫藥調配物
WO2016162819A1 (en) 2015-04-07 2016-10-13 Lupin Limited Stable aqueous pharmaceutical composition of anti-tnf alpha antibody
GB201612317D0 (en) 2016-07-15 2016-08-31 Philogen Spa Antibody compositions
US20200069799A1 (en) 2018-08-28 2020-03-05 Arecor Limited Stabilized antibody protein solutions
GB201703062D0 (en) 2017-02-24 2017-04-12 Arecor Ltd Stabilized antibody protein solutions
US11608357B2 (en) 2018-08-28 2023-03-21 Arecor Limited Stabilized antibody protein solutions
GB201703063D0 (en) 2017-02-24 2017-04-12 Arecor Ltd Stabilized antibody protein solutions
EP3372241A1 (en) 2017-03-06 2018-09-12 Ares Trading S.A. Liquid pharmaceutical composition
EP3372242A1 (en) 2017-03-06 2018-09-12 Ares Trading S.A. Liquid pharmaceutical composition
WO2018184692A1 (en) 2017-04-07 2018-10-11 Ares Trading S.A. Liquid pharmaceutical composition
WO2018184693A1 (en) 2017-04-07 2018-10-11 Ares Trading S.A. Liquid pharmaceutical composition

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010505852A (ja) 2006-10-06 2010-02-25 アムジエン・インコーポレーテツド 安定な抗体製剤
JP2010529999A (ja) 2007-06-14 2010-09-02 バイオジェン・アイデック・エムエイ・インコーポレイテッド 抗体製剤
JP2014524748A (ja) 2011-07-19 2014-09-25 グラクソ グループ リミテッド FcRn結合の増加したTNF−α抗原結合タンパク質
JP2015509526A (ja) 2012-03-07 2015-03-30 カディラ ヘルスケア リミティド 医薬製剤
JP2015527402A (ja) 2012-09-07 2015-09-17 コヒラス・バイオサイエンシズ・インコーポレイテッド 安定水性アダリムマブ製剤
JP2016505633A (ja) 2013-01-24 2016-02-25 グラクソスミスクライン、インテレクチュアル、プロパティー、ディベロップメント、リミテッドGlaxosmithkline Intellectual Property Development Limited TNFα抗原結合性タンパク質
JP2016117732A (ja) 2014-12-23 2016-06-30 ファイザー・インク 安定な水性抗体製剤

Also Published As

Publication number Publication date
WO2018162503A1 (en) 2018-09-13
US20230233463A1 (en) 2023-07-27
JP2020511443A (ja) 2020-04-16
US20200016075A1 (en) 2020-01-16
EP3592385B1 (en) 2022-05-04
EP3592385A1 (en) 2020-01-15
EP3372241A1 (en) 2018-09-12
US11534403B2 (en) 2022-12-27

Similar Documents

Publication Publication Date Title
JP7220664B2 (ja) 液体医薬組成物
JP7357540B2 (ja) 液体医薬組成物
JP7473603B2 (ja) 液体医薬組成物
AU2013255413C1 (en) Pharmaceutical formulations of TNF-alpha antibodies
JP2022547162A (ja) 抗IL-23p19抗体製剤
AU2019407063B2 (en) Protein solution formulation containing high concentration of an anti-VEGF antibody
WO2018184692A1 (en) Liquid pharmaceutical composition
WO2018184693A1 (en) Liquid pharmaceutical composition
AU2006222233A1 (en) Formulation for aviptadil
JP2024507347A (ja) Fcドメインを含む操作されたタンパク質コンストラクトの水性組成物
HK40005809B (en) Liquid pharmaceutical composition
OA17126A (en) Pharmaceutical formulations of TNF-alpha antibodies

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20210217

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20210217

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20220308

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20220606

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20221206

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20221208

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20230131

R150 Certificate of patent or registration of utility model

Ref document number: 7220664

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150