JP7739182B2 - 高濃度タンパク質製剤の粘度を低減させるための低分子量ポリビニルピロリドン（ｐｖｐ）の使用 - Google Patents

高濃度タンパク質製剤の粘度を低減させるための低分子量ポリビニルピロリドン（ｐｖｐ）の使用

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Publication number
JP7739182B2
JP7739182B2 JP2021562350A JP2021562350A JP7739182B2 JP 7739182 B2 JP7739182 B2 JP 7739182B2 JP 2021562350 A JP2021562350 A JP 2021562350A JP 2021562350 A JP2021562350 A JP 2021562350A JP 7739182 B2 JP7739182 B2 JP 7739182B2
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Prior art keywords
pvp
viscosity
composition
antibody
concentration
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JP2021562350A
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Japanese (ja)
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JP2022529996A (ja
JP2022529996A5 (https=
Inventor
スローイー，クリストファー・ジェームズ
Original Assignee
アムジエン・インコーポレーテツド
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Classifications

    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K9/14—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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
JP2021562350A 2019-04-23 2020-04-22 高濃度タンパク質製剤の粘度を低減させるための低分子量ポリビニルピロリドン（ｐｖｐ）の使用 Active JP7739182B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962837647P 2019-04-23 2019-04-23
US62/837,647 2019-04-23
PCT/US2020/029328 WO2020219550A1 (en) 2019-04-23 2020-04-22 The use of low molecular weight polyvinylpyrrolidone (pvp) to reduce viscosity of high concentration protein formulations

Publications (3)

Publication Number Publication Date
JP2022529996A JP2022529996A (ja) 2022-06-27
JP2022529996A5 JP2022529996A5 (https=) 2023-05-01
JP7739182B2 true JP7739182B2 (ja) 2025-09-16

Family

ID=70614677

Family Applications (1)

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JP2021562350A Active JP7739182B2 (ja) 2019-04-23 2020-04-22 高濃度タンパク質製剤の粘度を低減させるための低分子量ポリビニルピロリドン（ｐｖｐ）の使用

Country Status (8)

Country Link
US (1) US12599669B2 (https=)
EP (1) EP3958840A1 (https=)
JP (1) JP7739182B2 (https=)
CN (1) CN113660927A (https=)
AU (1) AU2020263318B2 (https=)
CA (1) CA3141857A1 (https=)
MX (1) MX2021012782A (https=)
WO (1) WO2020219550A1 (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK4364724T3 (da) 2018-05-10 2025-12-22 Regeneron Pharma Formuleringer med høj koncentration af VEGF-receptorfusionsprotein
WO2022217021A1 (en) * 2021-04-09 2022-10-13 Avantor Performance Materials, Llc Performance-enhancing excipients and methods of reducing viscosity and increasing stability of biologic formulations

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002516612A (ja) 1997-06-03 2002-06-04 コールター ファーマシューティカル，インコーポレイティド 放射性同位体によって標識されたペプチドのための放射線保護剤
JP2005516971A (ja) 2001-12-21 2005-06-09 ジンマー オーソバイオロジクス，インコーポレイティド ポリペプチド増殖因子のためのポビドン含有担体
JP2010524948A (ja) 2007-04-17 2010-07-22 バクスター・インターナショナル・インコーポレイテッド 球形インスリン微小粒子の肺送達
JP2010248271A (ja) 2002-03-13 2010-11-04 Novartis Ag 医薬微粒子
JP2012512162A (ja) 2008-12-10 2012-05-31 アラーガン、インコーポレイテッド クロストリジウム毒素医薬組成物
US20170209587A1 (en) 2014-07-21 2017-07-27 Board Of Regents, The University Of Texas Sytem Formulations of intraarticular pharmaceutical agents and methods for preparing and using the same

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EA201391489A1 (ru) * 2011-04-07 2014-02-28 ГЛЭКСОСМИТКЛАЙН ЭлЭлСи Композиции со сниженной вязкостью
WO2016065181A1 (en) * 2014-10-23 2016-04-28 Amgen Inc. Reducing viscosity of pharmaceutical formulations
JP7377596B2 (ja) * 2017-02-22 2023-11-10 アムジエン・インコーポレーテツド 低粘度、高濃度エボロクマブ製剤及びそれらの製造方法
WO2018201064A1 (en) * 2017-04-28 2018-11-01 Amgen Inc. N-acetylated and non-acetylated dipeptides containing arginine to reduce the viscosity of viscous compositions of therapeutic polypeptides

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002516612A (ja) 1997-06-03 2002-06-04 コールター ファーマシューティカル，インコーポレイティド 放射性同位体によって標識されたペプチドのための放射線保護剤
JP2005516971A (ja) 2001-12-21 2005-06-09 ジンマー オーソバイオロジクス，インコーポレイティド ポリペプチド増殖因子のためのポビドン含有担体
JP2010248271A (ja) 2002-03-13 2010-11-04 Novartis Ag 医薬微粒子
JP2010524948A (ja) 2007-04-17 2010-07-22 バクスター・インターナショナル・インコーポレイテッド 球形インスリン微小粒子の肺送達
JP2012512162A (ja) 2008-12-10 2012-05-31 アラーガン、インコーポレイテッド クロストリジウム毒素医薬組成物
US20170209587A1 (en) 2014-07-21 2017-07-27 Board Of Regents, The University Of Texas Sytem Formulations of intraarticular pharmaceutical agents and methods for preparing and using the same

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
Pharmaceutical Research，1994年，Vol.11,No.5，pp.624-632

Also Published As

Publication number Publication date
US12599669B2 (en) 2026-04-14
AU2020263318B2 (en) 2025-10-23
CA3141857A1 (en) 2020-10-29
JP2022529996A (ja) 2022-06-27
EP3958840A1 (en) 2022-03-02
WO2020219550A1 (en) 2020-10-29
MX2021012782A (es) 2021-11-25
US20220226477A1 (en) 2022-07-21
CN113660927A (zh) 2021-11-16
AU2020263318A1 (en) 2021-10-21

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