JP2017531682A - 医薬製剤の粘度低下 - Google Patents

医薬製剤の粘度低下 Download PDF

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Publication number
JP2017531682A
JP2017531682A JP2017522169A JP2017522169A JP2017531682A JP 2017531682 A JP2017531682 A JP 2017531682A JP 2017522169 A JP2017522169 A JP 2017522169A JP 2017522169 A JP2017522169 A JP 2017522169A JP 2017531682 A JP2017531682 A JP 2017531682A
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Prior art keywords
viscosity
excipient
protein
concentration
formulation
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Pending
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JP2017522169A
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English (en)
Japanese (ja)
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JP2017531682A5 (enExample
Inventor
スローイー，クリストファー・ジェイムズ
カナプラン，セカール
Original Assignee
アムジエン・インコーポレーテツド
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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=JP2017531682(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by アムジエン・インコーポレーテツド filed Critical アムジエン・インコーポレーテツド
Publication of JP2017531682A publication Critical patent/JP2017531682A/ja
Publication of JP2017531682A5 publication Critical patent/JP2017531682A5/ja
Priority to JP2019191701A priority Critical patent/JP6965321B2/ja
Priority to JP2021170676A priority patent/JP7411615B2/ja
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
    • 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (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)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (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)
JP2017522169A 2014-10-23 2015-10-22 医薬製剤の粘度低下 Pending JP2017531682A (ja)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2019191701A JP6965321B2 (ja) 2014-10-23 2019-10-21 医薬製剤の粘度低下
JP2021170676A JP7411615B2 (ja) 2014-10-23 2021-10-19 医薬製剤の粘度低下

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

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2019191701A Division JP6965321B2 (ja) 2014-10-23 2019-10-21 医薬製剤の粘度低下

Publications (2)

Publication Number Publication Date
JP2017531682A true JP2017531682A (ja) 2017-10-26
JP2017531682A5 JP2017531682A5 (enExample) 2018-09-27

Family

ID=54427875

Family Applications (3)

Application Number Title Priority Date Filing Date
JP2017522169A Pending JP2017531682A (ja) 2014-10-23 2015-10-22 医薬製剤の粘度低下
JP2019191701A Active JP6965321B2 (ja) 2014-10-23 2019-10-21 医薬製剤の粘度低下
JP2021170676A Active JP7411615B2 (ja) 2014-10-23 2021-10-19 医薬製剤の粘度低下

Family Applications After (2)

Application Number Title Priority Date Filing Date
JP2019191701A Active JP6965321B2 (ja) 2014-10-23 2019-10-21 医薬製剤の粘度低下
JP2021170676A Active JP7411615B2 (ja) 2014-10-23 2021-10-19 医薬製剤の粘度低下

Country Status (17)

Country Link
US (3) US11813328B2 (enExample)
EP (2) EP3209332B1 (enExample)
JP (3) JP2017531682A (enExample)
KR (1) KR102534017B1 (enExample)
CN (2) CN107206070B (enExample)
AU (2) AU2015335743B2 (enExample)
BR (1) BR112017008125B1 (enExample)
CA (1) CA2964786C (enExample)
CL (2) CL2017000984A1 (enExample)
EA (3) EA038462B1 (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)

Cited By (1)

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JP2023513312A (ja) * 2020-02-13 2023-03-30 アムジェン インコーポレイテッド ヒト抗ｔｓｌｐ抗体の製剤及び炎症性疾患を治療する方法

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WO2018067987A1 (en) * 2016-10-06 2018-04-12 Amgen Inc. Reduced viscosity protein pharmaceutical formulations
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
WO2018200533A1 (en) 2017-04-28 2018-11-01 Amgen Inc. Excipients to reduce the viscosity of antibody formulations and formulation compositions
ES3036143T3 (en) * 2017-04-28 2025-09-15 Amgen Inc N-acetylated and non-acetylated dipeptides containing arginine to reduce the viscosity of viscous compositions of therapeutic polypeptides
WO2018211517A1 (en) 2017-05-16 2018-11-22 Bhami's Research Laboratory, Pvt. Ltd. High concentration protein formulations with reduced viscosity
ES2894629T3 (es) 2017-06-16 2022-02-15 Zealand Pharma As Pautas posológicas para la administración de análogos del péptido 2 similar al glucagón (GLP-2)
US20200289621A1 (en) * 2017-09-22 2020-09-17 Asahi Kasei Pharma Corporation Teriparatide-containing liquid pharmaceutical composition having excellent stability
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
US20210290534A1 (en) 2018-07-05 2021-09-23 Bayer Aktiengesellschaft METHOD FOR THE PRODUCTION OF FREEZE-DRIED PELLETS COMPRISING AN ANTI-COAGULATION FACTOR XIa (FXIa) ANTIBODY
CN120795059A (zh) 2018-08-27 2025-10-17 瑞泽恩制药公司 拉曼光谱在下游纯化中的应用
EP3628683A1 (en) * 2018-09-28 2020-04-01 Zealand Pharma A/S Formulations of glucagon-like-peptide-2 (glp-2) analogues
US12599669B2 (en) 2019-04-23 2026-04-14 Amgen Inc. Use of low molecular weight polyvinylpyrrolidone (PVP) to reduce viscosity of high concentration protein formulations
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
CN117355321A (zh) * 2021-04-09 2024-01-05 安万托特性材料股份有限公司 增强性能的赋形剂以及降低生物制剂的粘度和提高生物制剂的稳定性的方法
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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Patent Citations (5)

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Publication number Priority date Publication date Assignee Title
JP2001522814A (ja) * 1997-11-07 2001-11-20 カイロン コーポレイション 増大されたｉｇｆ−ｉ溶解性を提供する組成物
WO2007074880A1 (ja) * 2005-12-28 2007-07-05 Chugai Seiyaku Kabushiki Kaisha 抗体含有安定化製剤
JP2011067202A (ja) * 2009-08-31 2011-04-07 Sanyo Chem Ind Ltd タンパク質水溶液の安定化剤、この安定化剤を含有するタンパク質水溶液及びタンパク質の安定化方法
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JP2013525484A (ja) * 2010-05-03 2013-06-20 ジェネンテック， インコーポレイテッド タンパク質含有製剤の粘度を低減させるために有用な組成物及び方法

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2023513312A (ja) * 2020-02-13 2023-03-30 アムジェン インコーポレイテッド ヒト抗ｔｓｌｐ抗体の製剤及び炎症性疾患を治療する方法

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KR20170071518A (ko) 2017-06-23
IL251726B (en) 2021-12-01
MX2021015789A (es) 2022-01-27
EA033444B1 (ru) 2019-10-31
CA2964786C (en) 2023-10-17
US12318447B2 (en) 2025-06-03
ZA201702762B (en) 2022-12-21
JP7411615B2 (ja) 2024-01-11
BR112017008125B1 (pt) 2023-11-21
KR102534017B1 (ko) 2023-05-19
MA54716A (fr) 2021-11-17
CL2017000984A1 (es) 2018-01-05
EA201790787A1 (ru) 2017-08-31
AU2015335743B2 (en) 2020-12-24
MX388858B (es) 2025-03-20
US20170333559A1 (en) 2017-11-23
EP3909611A1 (en) 2021-11-17
EP3209332A1 (en) 2017-08-30
CA2964786A1 (en) 2016-04-28
AU2021200990B2 (en) 2023-02-16
EA201991447A1 (ru) 2019-11-29
CN107206070B (zh) 2022-01-18
MX2017005243A (es) 2017-08-18
BR112017008125A2 (pt) 2018-06-19
EP3209332B1 (en) 2021-05-26
CL2019002190A1 (es) 2019-11-22
JP6965321B2 (ja) 2021-11-10
IL287947B1 (en) 2024-04-01
JP2020037559A (ja) 2020-03-12
CN114569716A (zh) 2022-06-03
AU2015335743A1 (en) 2017-05-04
IL287947B2 (en) 2024-08-01
US11813328B2 (en) 2023-11-14
JP2022009223A (ja) 2022-01-14
EA038462B1 (ru) 2021-08-31
AU2021200990A1 (en) 2021-03-11
US20250345421A1 (en) 2025-11-13
ES2964713T3 (es) 2024-04-09
IL287947A (en) 2022-01-01
EP3909611B1 (en) 2023-08-30
EA202191513A1 (ru) 2021-11-30
US20240066124A1 (en) 2024-02-29
CN107206070A (zh) 2017-09-26
IL251726A0 (en) 2017-06-29
WO2016065181A1 (en) 2016-04-28
SG11201703152RA (en) 2017-05-30

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