CN113827704B - 稳定蛋白质组合物 - Google Patents

稳定蛋白质组合物 Download PDF

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Publication number
CN113827704B
CN113827704B CN202111110779.9A CN202111110779A CN113827704B CN 113827704 B CN113827704 B CN 113827704B CN 202111110779 A CN202111110779 A CN 202111110779A CN 113827704 B CN113827704 B CN 113827704B
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China
Prior art keywords
protein
phase
peg
aflibercept
concentration
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CN202111110779.9A
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English (en)
Chinese (zh)
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CN113827704A (zh
Inventor
H·陈
E·施莱辛格
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Regeneron Pharmaceuticals Inc
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Regeneron Pharmaceuticals Inc
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Priority to CN202111110779.9A priority Critical patent/CN113827704B/zh
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/179Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K9/0048Eye, e.g. artificial tears
    • A61K9/0051Ocular inserts, ocular implants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L71/00Compositions of polyethers obtained by reactions forming an ether link in the main chain; Compositions of derivatives of such polymers
    • C08L71/08Polyethers derived from hydroxy compounds or from their metallic derivatives
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L2203/00Applications
    • C08L2203/02Applications for biomedical use

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  • 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)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Polymers & Plastics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Cell Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Peptides Or Proteins (AREA)
CN202111110779.9A 2015-10-16 2016-10-14 稳定蛋白质组合物 Active CN113827704B (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202111110779.9A CN113827704B (zh) 2015-10-16 2016-10-14 稳定蛋白质组合物

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201562242412P 2015-10-16 2015-10-16
US62/242,412 2015-10-16
PCT/US2016/057019 WO2017066554A1 (en) 2015-10-16 2016-10-14 Stable protein compositions
CN202111110779.9A CN113827704B (zh) 2015-10-16 2016-10-14 稳定蛋白质组合物
CN201680067420.9A CN108348462B (zh) 2015-10-16 2016-10-14 稳定蛋白质组合物

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CN201680067420.9A Division CN108348462B (zh) 2015-10-16 2016-10-14 稳定蛋白质组合物

Publications (2)

Publication Number Publication Date
CN113827704A CN113827704A (zh) 2021-12-24
CN113827704B true CN113827704B (zh) 2024-07-12

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CN202111110779.9A Active CN113827704B (zh) 2015-10-16 2016-10-14 稳定蛋白质组合物
CN201680067420.9A Active CN108348462B (zh) 2015-10-16 2016-10-14 稳定蛋白质组合物

Family Applications After (1)

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CN201680067420.9A Active CN108348462B (zh) 2015-10-16 2016-10-14 稳定蛋白质组合物

Country Status (13)

Country Link
US (1) US20180289623A1 (enExample)
EP (1) EP3362041A1 (enExample)
JP (3) JP6853245B2 (enExample)
KR (1) KR102731879B1 (enExample)
CN (2) CN113827704B (enExample)
AU (2) AU2016340072B2 (enExample)
CA (1) CA3001346A1 (enExample)
EA (1) EA036623B1 (enExample)
IL (2) IL258570B2 (enExample)
MX (2) MX390837B (enExample)
MY (2) MY199546A (enExample)
WO (1) WO2017066554A1 (enExample)
ZA (1) ZA201802460B (enExample)

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ES2909777T3 (es) 2011-11-18 2022-05-10 Regeneron Pharma Formulación de liberación prolongada que comprende micropartículas para su uso en el humor vítreo del ojo para tratar trastornos oculares vasculares
IL258570B2 (en) * 2015-10-16 2024-07-01 Regeneron Pharma Stable protein preparations
US12156900B2 (en) 2017-11-17 2024-12-03 Amgen Inc. VEGFR-Fc fusion protein formulations
PT4364724T (pt) 2018-05-10 2025-12-16 Regeneron Pharma Formulações contendo uma proteína de fusão do recetor do vegf de concentração elevada
US20220054586A1 (en) * 2018-09-10 2022-02-24 Samsung Bioepis Co., Ltd. Liquid composition comprising protein
CN112294760B (zh) * 2019-07-26 2025-12-12 宁波新致生物科技有限公司 一种液体制剂及其应用
WO2025235973A1 (en) * 2024-05-09 2025-11-13 Deep Brain Bci Corporation Implantable medical devices for delivering therapeutics and brain-computer interface systems

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US6004549A (en) * 1994-12-14 1999-12-21 Schering Corporation Crystalline protein controlled release compositions
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CA2588449A1 (en) * 2004-11-24 2006-06-01 Therakine Corporation An implant for intraocular drug delivery
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CN101559041B (zh) * 2009-05-19 2014-01-15 中国科学院过程工程研究所 粒径均一的多肽药物缓释微球或微囊制剂及制备方法
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WO2012142318A1 (en) 2011-04-14 2012-10-18 The Regents Of The University Of California Multilayer thin film drug delivery device and methods of making and using the same
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New Insight into the Role of Polyethylene Glycol Acting as Protein Release Modifier in Lipidic Implants;Sandra Herrmann et al;Pharmaceutical Research;第24卷(第8期);第1530页右栏第1段,第1531页左栏图3下数第2段,第1532页左栏图5下数第2段至右栏第1段,第1533页右栏第3段,第1534页左栏倒数第3段,图7,第1534页图9下数第1段,第1528页左栏第3段,第1533页左栏图7下数第1段至右栏第2段,第1529页右栏第2段和图1 *

Also Published As

Publication number Publication date
MX2018004695A (es) 2019-03-14
BR112018007507A2 (pt) 2018-10-23
JP2018538243A (ja) 2018-12-27
JP7179112B2 (ja) 2022-11-28
JP6853245B2 (ja) 2021-03-31
CA3001346A1 (en) 2017-04-20
AU2016340072B2 (en) 2021-10-28
MX2022003376A (es) 2022-04-12
KR102731879B1 (ko) 2024-11-20
JP7547438B2 (ja) 2024-09-09
IL258570B1 (en) 2024-03-01
AU2022200475B2 (en) 2023-09-14
JP2021098742A (ja) 2021-07-01
WO2017066554A1 (en) 2017-04-20
EA201890979A1 (ru) 2018-10-31
CN113827704A (zh) 2021-12-24
ZA201802460B (en) 2024-09-25
MY193964A (en) 2022-11-03
US20180289623A1 (en) 2018-10-11
IL258570A (en) 2018-05-31
IL310557A (en) 2024-03-01
EA036623B1 (ru) 2020-12-01
IL258570B2 (en) 2024-07-01
KR20180063311A (ko) 2018-06-11
JP2023025046A (ja) 2023-02-21
AU2016340072A1 (en) 2018-05-10
CN108348462B (zh) 2021-10-15
MX390837B (es) 2025-03-21
EP3362041A1 (en) 2018-08-22
MY199546A (en) 2023-11-06
AU2022200475A1 (en) 2022-02-17
CN108348462A (zh) 2018-07-31

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