KR102534017B1 - 약제학적 제형의 점도 감소 - Google Patents

약제학적 제형의 점도 감소 Download PDF

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Publication number
KR102534017B1
KR102534017B1 KR1020177011706A KR20177011706A KR102534017B1 KR 102534017 B1 KR102534017 B1 KR 102534017B1 KR 1020177011706 A KR1020177011706 A KR 1020177011706A KR 20177011706 A KR20177011706 A KR 20177011706A KR 102534017 B1 KR102534017 B1 KR 102534017B1
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acetyl
viscosity
excipient
antibody
concentration
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Korean (ko)
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KR20170071518A (ko
Inventor
크리스토퍼 제임스 슬로에이
세카 카나푸람
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암젠 인크
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    • 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
    • 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
    • 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
    • A61K9/0012Galenical 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
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Mycology (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (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)
KR1020177011706A 2014-10-23 2015-10-22 약제학적 제형의 점도 감소 Active KR102534017B1 (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201462067637P 2014-10-23 2014-10-23
US62/067,637 2014-10-23
PCT/US2015/056972 WO2016065181A1 (en) 2014-10-23 2015-10-22 Reducing viscosity of pharmaceutical formulations

Publications (2)

Publication Number Publication Date
KR20170071518A KR20170071518A (ko) 2017-06-23
KR102534017B1 true KR102534017B1 (ko) 2023-05-19

Family

ID=54427875

Family Applications (1)

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KR1020177011706A Active KR102534017B1 (ko) 2014-10-23 2015-10-22 약제학적 제형의 점도 감소

Country Status (17)

Country Link
US (3) US11813328B2 (enExample)
EP (2) EP3209332B1 (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) EA033444B1 (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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MA46466A (fr) 2016-10-06 2019-08-14 Amgen Inc Formulations pharmaceutiques de protéines à viscosité réduite
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
US12257343B2 (en) 2017-04-28 2025-03-25 Amgen Inc. Excipients to reduce the viscosity of antibody formulations and formulation compositions
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
EP3624846B1 (en) 2017-05-16 2024-08-07 Bhami's Research Laboratory, Pvt. Ltd. High concentration protein formulations with reduced viscosity including a combination of nicotinic acid and tryoptophan
EP4424362A3 (en) 2017-06-16 2024-11-27 Zealand Pharma A/S Dosage regimes for the administration of glucagon-like-peptide-2 (glp-2) analogues
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WO2019106206A1 (en) 2017-12-01 2019-06-06 Fyb 202 Project Gmbh Stable, low viscosity, high concentration liquid formulations of an anti-il-12/23p40 antibody
JP2021529800A (ja) 2018-07-05 2021-11-04 バイエル アクチェンゲゼルシャフトBayer Aktiengesellschaft 抗FXIa抗体のための新規な安定した高濃度製剤
IL280880B2 (en) 2018-08-27 2025-04-01 Regeneron Pharma Using 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
WO2020219550A1 (en) * 2019-04-23 2020-10-29 Amgen Inc. The use of low molecular weight polyvinylpyrrolidone (pvp) to reduce viscosity of high concentration protein formulations
IL295042A (en) * 2020-02-13 2022-09-01 Amgen Inc 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
KR20220126654A (ko) * 2021-03-09 2022-09-16 (주)지아이이노베이션 IgE Fc 수용체의 알파 서브유닛의 세포외 도메인을 포함하는 융합단백질의 제형
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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Also Published As

Publication number Publication date
MX388858B (es) 2025-03-20
JP2020037559A (ja) 2020-03-12
IL287947B1 (en) 2024-04-01
MX2017005243A (es) 2017-08-18
CA2964786C (en) 2023-10-17
AU2015335743A1 (en) 2017-05-04
EP3909611B1 (en) 2023-08-30
CN107206070B (zh) 2022-01-18
IL251726A0 (en) 2017-06-29
MX2021015789A (es) 2022-01-27
IL287947A (en) 2022-01-01
EP3209332B1 (en) 2021-05-26
WO2016065181A1 (en) 2016-04-28
CN107206070A (zh) 2017-09-26
ZA201702762B (en) 2022-12-21
SG11201703152RA (en) 2017-05-30
IL251726B (en) 2021-12-01
JP2017531682A (ja) 2017-10-26
BR112017008125B1 (pt) 2023-11-21
US20250345421A1 (en) 2025-11-13
AU2021200990B2 (en) 2023-02-16
EA201991447A1 (ru) 2019-11-29
EA202191513A1 (ru) 2021-11-30
MA54716A (fr) 2021-11-17
US12318447B2 (en) 2025-06-03
US11813328B2 (en) 2023-11-14
EA033444B1 (ru) 2019-10-31
AU2021200990A1 (en) 2021-03-11
CN114569716A (zh) 2022-06-03
EP3209332A1 (en) 2017-08-30
EA038462B1 (ru) 2021-08-31
JP2022009223A (ja) 2022-01-14
US20240066124A1 (en) 2024-02-29
IL287947B2 (en) 2024-08-01
AU2015335743B2 (en) 2020-12-24
JP7411615B2 (ja) 2024-01-11
KR20170071518A (ko) 2017-06-23
CA2964786A1 (en) 2016-04-28
BR112017008125A2 (pt) 2018-06-19
CL2017000984A1 (es) 2018-01-05
CL2019002190A1 (es) 2019-11-22
JP6965321B2 (ja) 2021-11-10
US20170333559A1 (en) 2017-11-23
EP3909611A1 (en) 2021-11-17
ES2964713T3 (es) 2024-04-09
EA201790787A1 (ru) 2017-08-31

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