EA038462B1 - Снижение вязкости фармацевтических составов - Google Patents

Снижение вязкости фармацевтических составов Download PDF

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Publication number
EA038462B1
EA038462B1 EA201991447A EA201991447A EA038462B1 EA 038462 B1 EA038462 B1 EA 038462B1 EA 201991447 A EA201991447 A EA 201991447A EA 201991447 A EA201991447 A EA 201991447A EA 038462 B1 EA038462 B1 EA 038462B1
Authority
EA
Eurasian Patent Office
Prior art keywords
viscosity
excipient
protein
antibody
acetyl
Prior art date
Application number
EA201991447A
Other languages
English (en)
Russian (ru)
Other versions
EA201991447A1 (ru
Inventor
Кристофер Джеймс Слоуи
Секхар Канапурам
Original Assignee
Эмджен Инк.
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=54427875&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EA038462(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Эмджен Инк. filed Critical Эмджен Инк.
Publication of EA201991447A1 publication Critical patent/EA201991447A1/ru
Publication of EA038462B1 publication Critical patent/EA038462B1/ru

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Mycology (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Endocrinology (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
EA201991447A 2014-10-23 2015-10-22 Снижение вязкости фармацевтических составов EA038462B1 (ru)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201462067637P 2014-10-23 2014-10-23

Publications (2)

Publication Number Publication Date
EA201991447A1 EA201991447A1 (ru) 2019-11-29
EA038462B1 true EA038462B1 (ru) 2021-08-31

Family

ID=54427875

Family Applications (3)

Application Number Title Priority Date Filing Date
EA202191513A EA202191513A1 (ru) 2014-10-23 2015-10-22 Снижение вязкости фармацевтических составов
EA201790787A EA033444B1 (ru) 2014-10-23 2015-10-22 Снижение вязкости фармацевтических составов
EA201991447A EA038462B1 (ru) 2014-10-23 2015-10-22 Снижение вязкости фармацевтических составов

Family Applications Before (2)

Application Number Title Priority Date Filing Date
EA202191513A EA202191513A1 (ru) 2014-10-23 2015-10-22 Снижение вязкости фармацевтических составов
EA201790787A EA033444B1 (ru) 2014-10-23 2015-10-22 Снижение вязкости фармацевтических составов

Country Status (17)

Country Link
US (3) US11813328B2 (enExample)
EP (2) EP3909611B1 (enExample)
JP (3) JP2017531682A (enExample)
KR (1) KR102534017B1 (enExample)
CN (2) CN114569716A (enExample)
AU (2) AU2015335743B2 (enExample)
BR (1) BR112017008125B1 (enExample)
CA (1) CA2964786C (enExample)
CL (2) CL2017000984A1 (enExample)
EA (3) EA202191513A1 (enExample)
ES (1) ES2964713T3 (enExample)
IL (2) IL287947B2 (enExample)
MA (1) MA54716A (enExample)
MX (2) MX388858B (enExample)
SG (1) SG11201703152RA (enExample)
WO (1) WO2016065181A1 (enExample)
ZA (1) ZA201702762B (enExample)

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JP2017531682A (ja) 2014-10-23 2017-10-26 アムジエン・インコーポレーテツド 医薬製剤の粘度低下
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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
AU2018258676B2 (en) * 2017-04-28 2024-09-19 Amgen Inc. N-acetylated and non-acetylated dipeptides containing arginine to reduce the viscosity of viscous compositions of therapeutic polypeptides
EP3615065A1 (en) 2017-04-28 2020-03-04 Amgen Inc. Excipients to reduce the viscosity of antibody formulations and formulation compositions
US10646569B2 (en) 2017-05-16 2020-05-12 Bhami's Research Laboratory, Pvt. Ltd. High concentration protein formulations with reduced viscosity
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AU2019297498A1 (en) 2018-07-05 2021-01-21 Bayer Aktiengesellschaft Method for the production of freeze-dried pellets comprising an anti-coagulation factor xia (FXIa) antibody
EP3774841A1 (en) 2018-08-27 2021-02-17 Regeneron Pharmaceuticals, Inc. Use of raman spectroscopy in downstream purification
EP3628683A1 (en) * 2018-09-28 2020-04-01 Zealand Pharma A/S Formulations of glucagon-like-peptide-2 (glp-2) analogues
JP7739182B2 (ja) * 2019-04-23 2025-09-16 アムジエン・インコーポレーテツド 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
CA3166964A1 (en) * 2020-02-13 2021-08-19 Alexis Lueras Formulations of human anti-tslp antibodies and methods of treating inflammatory disease
KR102746418B1 (ko) * 2020-12-03 2024-12-26 동국대학교 산학협력단 N-아세틸-l-아르기닌을 포함하는 단백질 응집 억제용 조성물
MX2023010457A (es) * 2021-03-09 2023-09-14 Gi Innovation Inc Formulacion de proteina de fusion que incluye el dominio extracelular de la subunidad alfa del receptor fc de ige.
EP4319795A4 (en) * 2021-04-09 2025-03-05 Avantor Performance Materials, LLC Performance-enhancing excipients and methods of reducing viscosity and increasing stability of biologic formulations
WO2025175164A1 (en) * 2024-02-16 2025-08-21 Regeneron Pharmaceuticals, Inc. Methods of producing concentrated formulated drug substances comprising proteins, and concentrated formulated drug substance made by the methods

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Publication number Priority date Publication date Assignee Title
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Also Published As

Publication number Publication date
WO2016065181A1 (en) 2016-04-28
KR20170071518A (ko) 2017-06-23
EP3209332A1 (en) 2017-08-30
IL251726B (en) 2021-12-01
CN107206070A (zh) 2017-09-26
EP3909611B1 (en) 2023-08-30
JP2020037559A (ja) 2020-03-12
AU2015335743A1 (en) 2017-05-04
CN114569716A (zh) 2022-06-03
JP6965321B2 (ja) 2021-11-10
AU2021200990B2 (en) 2023-02-16
BR112017008125A2 (pt) 2018-06-19
CL2017000984A1 (es) 2018-01-05
AU2015335743B2 (en) 2020-12-24
US11813328B2 (en) 2023-11-14
EP3209332B1 (en) 2021-05-26
JP7411615B2 (ja) 2024-01-11
IL251726A0 (en) 2017-06-29
US20240066124A1 (en) 2024-02-29
MA54716A (fr) 2021-11-17
IL287947A (en) 2022-01-01
KR102534017B1 (ko) 2023-05-19
EA033444B1 (ru) 2019-10-31
US12318447B2 (en) 2025-06-03
US20250345421A1 (en) 2025-11-13
CL2019002190A1 (es) 2019-11-22
BR112017008125B1 (pt) 2023-11-21
ES2964713T3 (es) 2024-04-09
ZA201702762B (en) 2022-12-21
IL287947B2 (en) 2024-08-01
JP2017531682A (ja) 2017-10-26
IL287947B1 (en) 2024-04-01
SG11201703152RA (en) 2017-05-30
MX2017005243A (es) 2017-08-18
EA201991447A1 (ru) 2019-11-29
MX2021015789A (es) 2022-01-27
CA2964786A1 (en) 2016-04-28
EP3909611A1 (en) 2021-11-17
AU2021200990A1 (en) 2021-03-11
EA202191513A1 (ru) 2021-11-30
US20170333559A1 (en) 2017-11-23
JP2022009223A (ja) 2022-01-14
CN107206070B (zh) 2022-01-18
CA2964786C (en) 2023-10-17
EA201790787A1 (ru) 2017-08-31
MX388858B (es) 2025-03-20

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