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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viscosity
excipient
protein
concentration
formulation
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Japanese (ja)
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JP2017531682A5 (cg-RX-API-DMAC7.html
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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
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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
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    • 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
    • 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
    • A61K9/0012Galenical 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

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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)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (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)
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 (cg-RX-API-DMAC7.html) 2018-09-27

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Family Applications (3)

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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

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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 (cg-RX-API-DMAC7.html)
EP (2) EP3909611B1 (cg-RX-API-DMAC7.html)
JP (3) JP2017531682A (cg-RX-API-DMAC7.html)
KR (1) KR102534017B1 (cg-RX-API-DMAC7.html)
CN (2) CN114569716A (cg-RX-API-DMAC7.html)
AU (2) AU2015335743B2 (cg-RX-API-DMAC7.html)
BR (1) BR112017008125B1 (cg-RX-API-DMAC7.html)
CA (1) CA2964786C (cg-RX-API-DMAC7.html)
CL (2) CL2017000984A1 (cg-RX-API-DMAC7.html)
EA (3) EA033444B1 (cg-RX-API-DMAC7.html)
ES (1) ES2964713T3 (cg-RX-API-DMAC7.html)
IL (2) IL287947B2 (cg-RX-API-DMAC7.html)
MA (1) MA54716A (cg-RX-API-DMAC7.html)
MX (2) MX388858B (cg-RX-API-DMAC7.html)
SG (1) SG11201703152RA (cg-RX-API-DMAC7.html)
WO (1) WO2016065181A1 (cg-RX-API-DMAC7.html)
ZA (1) ZA201702762B (cg-RX-API-DMAC7.html)

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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AU2015335743B2 (en) 2014-10-23 2020-12-24 Amgen Inc. Reducing viscosity of pharmaceutical formulations
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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
WO2018200533A1 (en) 2017-04-28 2018-11-01 Amgen Inc. Excipients to reduce the viscosity of antibody formulations and formulation compositions
MA48464A (fr) 2017-04-28 2020-03-04 Amgen Inc Dipeptides n-acétylés et non acétylés contenant de l'arginine destinés à réduire la viscosité de compositions visqueuses de polypeptides thérapeutiques
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
WO2018229252A1 (en) 2017-06-16 2018-12-20 Zealand Pharma A/S Dosage regimes for the administration of glucagon-like-peptide-2 (glp-2) analogues
JP6577683B2 (ja) * 2017-09-22 2019-09-18 旭化成ファーマ株式会社 安定性に優れるテリパラチド含有液状医薬組成物
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
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KR20210052389A (ko) 2018-08-27 2021-05-10 리제너론 파마슈티칼스 인코포레이티드 다운스트림 정제에서의 라만 분광법의 사용
EP3628683A1 (en) * 2018-09-28 2020-04-01 Zealand Pharma A/S Formulations of glucagon-like-peptide-2 (glp-2) analogues
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
KR102746418B1 (ko) * 2020-12-03 2024-12-26 동국대학교 산학협력단 N-아세틸-l-아르기닌을 포함하는 단백질 응집 억제용 조성물
PE20240120A1 (es) * 2021-03-09 2024-01-22 Gi Innovation Inc Formulacion de proteina de fusion que incluye el dominio extracelular de la subunidad alfa del receptor ige fc
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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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
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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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CL2019002190A1 (es) 2019-11-22
ZA201702762B (en) 2022-12-21
SG11201703152RA (en) 2017-05-30
US11813328B2 (en) 2023-11-14
CL2017000984A1 (es) 2018-01-05
KR102534017B1 (ko) 2023-05-19
CA2964786A1 (en) 2016-04-28
US12318447B2 (en) 2025-06-03
US20170333559A1 (en) 2017-11-23
IL287947B1 (en) 2024-04-01
CN114569716A (zh) 2022-06-03
ES2964713T3 (es) 2024-04-09
JP2020037559A (ja) 2020-03-12
KR20170071518A (ko) 2017-06-23
IL251726A0 (en) 2017-06-29
US20240066124A1 (en) 2024-02-29
MX2021015789A (es) 2022-01-27
BR112017008125B1 (pt) 2023-11-21
EA202191513A1 (ru) 2021-11-30
AU2021200990B2 (en) 2023-02-16
EA201991447A1 (ru) 2019-11-29
IL251726B (en) 2021-12-01
JP2022009223A (ja) 2022-01-14
WO2016065181A1 (en) 2016-04-28
EA038462B1 (ru) 2021-08-31
EP3209332B1 (en) 2021-05-26
CN107206070A (zh) 2017-09-26
MX388858B (es) 2025-03-20
EP3209332A1 (en) 2017-08-30
EA033444B1 (ru) 2019-10-31
IL287947B2 (en) 2024-08-01
CN107206070B (zh) 2022-01-18
AU2015335743B2 (en) 2020-12-24
EP3909611A1 (en) 2021-11-17
AU2021200990A1 (en) 2021-03-11
CA2964786C (en) 2023-10-17
AU2015335743A1 (en) 2017-05-04
US20250345421A1 (en) 2025-11-13
JP7411615B2 (ja) 2024-01-11
BR112017008125A2 (pt) 2018-06-19
JP6965321B2 (ja) 2021-11-10
EA201790787A1 (ru) 2017-08-31
EP3909611B1 (en) 2023-08-30
MX2017005243A (es) 2017-08-18
MA54716A (fr) 2021-11-17
IL287947A (en) 2022-01-01

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