JP7796646B2 - 抗体ニモツズマブの安定で高濃度の製剤 - Google Patents

抗体ニモツズマブの安定で高濃度の製剤

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Publication number
JP7796646B2
JP7796646B2 JP2022536924A JP2022536924A JP7796646B2 JP 7796646 B2 JP7796646 B2 JP 7796646B2 JP 2022536924 A JP2022536924 A JP 2022536924A JP 2022536924 A JP2022536924 A JP 2022536924A JP 7796646 B2 JP7796646 B2 JP 7796646B2
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JP
Japan
Prior art keywords
mab
formulation
concentration
nimotuzumab
range
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
JP2022536924A
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English (en)
Japanese (ja)
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JP2023509354A (ja
JP2023509354A5 (https=
Inventor
テレーロ、ヤイコ サッダン ヘルナンデス
サエス オルガ リデア フェルナンデス
トマス ポムパ、フリオ フェリペ サント
アリアス、メルセデス セデーニョ
デ ラ ルス ヘルナンデス、カティヤ ラシダ
アヨ、タミー ボッジアーノ
モンソン、カレット レオン
ヴィトロク、アドルフォ カスティージョ
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Centro de Immunologia Molecular
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Centro de Immunologia Molecular
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Publication date
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Publication of JP2023509354A publication Critical patent/JP2023509354A/ja
Publication of JP2023509354A5 publication Critical patent/JP2023509354A5/ja
Application granted granted Critical
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Classifications

    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • A61K9/0012—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
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays or needleless injectors
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61P35/00—Antineoplastic agents
    • 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
    • C07K16/2863—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 growth factors, growth regulators
    • 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
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • 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)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Inorganic Chemistry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
JP2022536924A 2019-12-17 2020-12-10 抗体ニモツズマブの安定で高濃度の製剤 Active JP7796646B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CU2019000104A CU20190104A7 (es) 2019-12-17 2019-12-17 Formulación estable del anticuerpo nimotuzumab
CUCU-2019-0104 2019-12-17
PCT/CU2020/050007 WO2021121444A2 (es) 2019-12-17 2020-12-10 Formulación estable y de alta concentración del anticuerpo nimotuzumab

Publications (3)

Publication Number Publication Date
JP2023509354A JP2023509354A (ja) 2023-03-08
JP2023509354A5 JP2023509354A5 (https=) 2023-12-12
JP7796646B2 true JP7796646B2 (ja) 2026-01-09

Family

ID=76478863

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2022536924A Active JP7796646B2 (ja) 2019-12-17 2020-12-10 抗体ニモツズマブの安定で高濃度の製剤

Country Status (12)

Country Link
US (1) US20230018364A1 (https=)
EP (1) EP4079294A2 (https=)
JP (1) JP7796646B2 (https=)
KR (1) KR20220119091A (https=)
CN (1) CN114867468A (https=)
AU (1) AU2020409887B2 (https=)
BR (1) BR112022010488A2 (https=)
CA (1) CA3163630A1 (https=)
CO (1) CO2022009693A2 (https=)
CU (1) CU20190104A7 (https=)
MX (1) MX2022007509A (https=)
WO (1) WO2021121444A2 (https=)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005063291A1 (ja) 2003-12-25 2005-07-14 Kirin Beer Kabushiki Kaisha 抗体を含有する安定な水性医薬製剤
JP2013515754A (ja) 2009-12-29 2013-05-09 エフ・ホフマン−ラ・ロシュ・アクチェンゲゼルシャフト 新規な抗体製剤
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
JP2015528464A (ja) 2012-08-31 2015-09-28 バイエル・ヘルスケア・エルエルシーＢａｙｅｒ ＨｅａｌｔｈＣａｒｅＬＬＣ 抗体およびタンパク質製剤
CN107898756A (zh) 2017-12-22 2018-04-13 东曜药业有限公司 一种用于皮下或肌肉注射的高浓度尼妥珠单抗制剂及其制备方法和应用

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JO3000B1 (ar) * 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
CA2654794A1 (en) * 2006-06-14 2007-12-21 Imclone Systems Incorporated Lyophilized formulations of anti-egfr antibodies
US9345661B2 (en) 2009-07-31 2016-05-24 Genentech, Inc. Subcutaneous anti-HER2 antibody formulations and uses thereof
AR078161A1 (es) 2009-09-11 2011-10-19 Hoffmann La Roche Formulaciones farmaceuticas muy concentradas de un anticuerpo anti cd20. uso de la formulacion. metodo de tratamiento.
EP3541413A2 (en) * 2016-11-21 2019-09-25 Polpharma Biologics S.A. Aqueous pharmaceutical formulations

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005063291A1 (ja) 2003-12-25 2005-07-14 Kirin Beer Kabushiki Kaisha 抗体を含有する安定な水性医薬製剤
JP2013515754A (ja) 2009-12-29 2013-05-09 エフ・ホフマン−ラ・ロシュ・アクチェンゲゼルシャフト 新規な抗体製剤
JP2015528464A (ja) 2012-08-31 2015-09-28 バイエル・ヘルスケア・エルエルシーＢａｙｅｒ ＨｅａｌｔｈＣａｒｅＬＬＣ 抗体およびタンパク質製剤
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
CN107898756A (zh) 2017-12-22 2018-04-13 东曜药业有限公司 一种用于皮下或肌肉注射的高浓度尼妥珠单抗制剂及其制备方法和应用

Also Published As

Publication number Publication date
JP2023509354A (ja) 2023-03-08
AU2020409887A1 (en) 2022-08-11
CA3163630A1 (en) 2021-06-24
MX2022007509A (es) 2022-07-01
WO2021121444A2 (es) 2021-06-24
CN114867468A (zh) 2022-08-05
CU20190104A7 (es) 2021-08-06
EP4079294A2 (en) 2022-10-26
BR112022010488A2 (pt) 2022-09-06
US20230018364A1 (en) 2023-01-19
CO2022009693A2 (es) 2022-07-19
WO2021121444A3 (es) 2022-02-24
KR20220119091A (ko) 2022-08-26
AU2020409887B2 (en) 2024-08-08

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