CN113660927A - 使用低分子量聚乙烯吡咯烷酮（pvp）降低高浓度蛋白质配制品的黏度 - Google Patents

使用低分子量聚乙烯吡咯烷酮（pvp）降低高浓度蛋白质配制品的黏度 Download PDF

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Publication number
CN113660927A
CN113660927A CN202080026162.6A CN202080026162A CN113660927A CN 113660927 A CN113660927 A CN 113660927A CN 202080026162 A CN202080026162 A CN 202080026162A CN 113660927 A CN113660927 A CN 113660927A
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CN
China
Prior art keywords
composition
pvp
viscosity
arginine
lyophilized powder
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.)
Pending
Application number
CN202080026162.6A
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English (en)
Chinese (zh)
Inventor
C·J·史罗埃
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Amgen Inc
Original Assignee
Amgen Inc
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Publication date
Application filed by Amgen Inc filed Critical Amgen Inc
Publication of CN113660927A publication Critical patent/CN113660927A/zh
Pending 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
    • 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
    • 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
    • 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)
CN202080026162.6A 2019-04-23 2020-04-22 使用低分子量聚乙烯吡咯烷酮（pvp）降低高浓度蛋白质配制品的黏度 Pending CN113660927A (zh)

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 (1)

Publication Number Publication Date
CN113660927A true CN113660927A (zh) 2021-11-16

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
CN202080026162.6A Pending CN113660927A (zh) 2019-04-23 2020-04-22 使用低分子量聚乙烯吡咯烷酮（pvp）降低高浓度蛋白质配制品的黏度

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 (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140044727A1 (en) * 2011-04-07 2014-02-13 Glaxosmithkline Llc Formulations with reduced viscosity
US20180237501A1 (en) * 2017-02-22 2018-08-23 Amgen Inc. Low-viscosity, high concentration evolocumab formulations and methods of making the same
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

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5961955A (en) 1997-06-03 1999-10-05 Coulter Pharmaceutical, Inc. Radioprotectant for peptides labeled with radioisotope
US6992066B2 (en) 1998-10-16 2006-01-31 Zimmer Orthobiologics, Inc. Povidone-containing carriers for polypeptide growth factors
US20080026068A1 (en) 2001-08-16 2008-01-31 Baxter Healthcare S.A. Pulmonary delivery of spherical insulin microparticles
US20050152980A1 (en) 2002-03-13 2005-07-14 Michael Ausborn Pharmeutical microparticles
CN105833254A (zh) 2008-12-10 2016-08-10 阿勒根公司 梭菌毒素药物组合物
US10646574B2 (en) 2014-07-21 2020-05-12 Board Of Regents, The University Of Texas System Formulations of intraarticular pharmaceutical agents and methods for preparing and using the same
WO2016065181A1 (en) * 2014-10-23 2016-04-28 Amgen Inc. Reducing viscosity of pharmaceutical formulations

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140044727A1 (en) * 2011-04-07 2014-02-13 Glaxosmithkline Llc Formulations with reduced viscosity
US20180237501A1 (en) * 2017-02-22 2018-08-23 Amgen Inc. Low-viscosity, high concentration evolocumab formulations and methods of making the same
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

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
VOLKER BUHLER: "Polyvinylpyrrolidone Excipients for Pharmaceuticals", 31 December 2005, SPRING, pages: 10 - 11 *
WAYNE R. GOMBOTZ ET AL.: "The Stabilization of a Human IgM Monoclonal Antibody with Poly(vinylpyrrolidone)", PHARMACEUTICAL RESEARCH, vol. 11, no. 5, pages 625 *

Also Published As

Publication number Publication date
JP7739182B2 (ja) 2025-09-16
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
AU2020263318A1 (en) 2021-10-21

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