AU2020263318B2 - The use of low molecular weight polyvinylpyrrolidone (PVP) to reduce viscosity of high concentration protein formulations - Google Patents

The use of low molecular weight polyvinylpyrrolidone (PVP) to reduce viscosity of high concentration protein formulations

Info

Publication number
AU2020263318B2
AU2020263318B2 AU2020263318A AU2020263318A AU2020263318B2 AU 2020263318 B2 AU2020263318 B2 AU 2020263318B2 AU 2020263318 A AU2020263318 A AU 2020263318A AU 2020263318 A AU2020263318 A AU 2020263318A AU 2020263318 B2 AU2020263318 B2 AU 2020263318B2
Authority
AU
Australia
Prior art keywords
pvp
viscosity
antibody
composition
concentration
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
AU2020263318A
Other languages
English (en)
Other versions
AU2020263318A1 (en
Inventor
Christopher James Sloey
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
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 Amgen Inc filed Critical Amgen Inc
Publication of AU2020263318A1 publication Critical patent/AU2020263318A1/en
Application granted granted Critical
Publication of AU2020263318B2 publication Critical patent/AU2020263318B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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

Landscapes

  • 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)
AU2020263318A 2019-04-23 2020-04-22 The use of low molecular weight polyvinylpyrrolidone (PVP) to reduce viscosity of high concentration protein formulations Active AU2020263318B2 (en)

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 (2)

Publication Number Publication Date
AU2020263318A1 AU2020263318A1 (en) 2021-10-21
AU2020263318B2 true AU2020263318B2 (en) 2025-10-23

Family

ID=70614677

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2020263318A Active AU2020263318B2 (en) 2019-04-23 2020-04-22 The use of low molecular weight polyvinylpyrrolidone (PVP) to reduce viscosity of high concentration protein formulations

Country Status (8)

Country Link
US (2) US12599669B2 (enExample)
EP (1) EP3958840A1 (enExample)
JP (1) JP7739182B2 (enExample)
CN (1) CN113660927A (enExample)
AU (1) AU2020263318B2 (enExample)
CA (1) CA3141857A1 (enExample)
MX (1) MX2021012782A (enExample)
WO (1) WO2020219550A1 (enExample)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RS67656B1 (sr) 2018-05-10 2026-02-27 Regeneron Pharma Formulacije koje sadrže visoke koncentracije fuzionog proteina vegf receptora
CN113660927A (zh) 2019-04-23 2021-11-16 安进公司 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
CA3214867A1 (en) * 2021-04-09 2022-10-13 Courtney O'DELL Performance-enhancing excipients and methods of reducing viscosity and increasing stability of biologic formulations

Citations (2)

* 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
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 (12)

* 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
JP4679822B2 (ja) 2002-03-13 2011-05-11 ノバルティス アーゲー 医薬微粒子
KR20110097772A (ko) 2008-11-17 2011-08-31 제넨테크, 인크. 생리적 조건하에 거대분자의 응집을 감소시키는 방법 및 제제
AU2009339292B2 (en) 2008-12-10 2016-01-21 Allergan, Inc. Clostridial toxin pharmaceutical compositions
WO2016014408A1 (en) 2014-07-21 2016-01-28 Board Of Regents, The University Of Texas System Formulations of intraarticular pharmaceutical agents and methods for preparing and using the same
ES2964713T3 (es) * 2014-10-23 2024-04-09 Amgen Inc Reducción de la viscosidad de formulaciones farmacéuticas
CN106511997A (zh) 2015-09-15 2017-03-22 上海抗体药物国家工程研究中心有限公司 一种稳定的蛋白制剂
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
MA48461A (fr) 2017-04-28 2020-03-04 Amgen Inc Excipients pour réduire la viscosité de formulations d'anticorps et compositions de formulation
CN113660927A (zh) 2019-04-23 2021-11-16 安进公司 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

Patent Citations (2)

* 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
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 (1)

* Cited by examiner, † Cited by third party
Title
GOMBOTZ W R ET AL: "The stabilization of a human IgM monoclonal antibody with poly(vinylpyrrolidone)", PHARMACEUTICAL RESEARCH, SPRINGER NEW YORK LLC, US, vol. 11, no. 5, 1994, pages 624 - 632. *

Also Published As

Publication number Publication date
US20220226477A1 (en) 2022-07-21
EP3958840A1 (en) 2022-03-02
WO2020219550A1 (en) 2020-10-29
CN113660927A (zh) 2021-11-16
CA3141857A1 (en) 2020-10-29
JP7739182B2 (ja) 2025-09-16
JP2022529996A (ja) 2022-06-27
US12599669B2 (en) 2026-04-14
US20260199478A1 (en) 2026-07-16
MX2021012782A (es) 2021-11-25
AU2020263318A1 (en) 2021-10-21

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