JP6742986B2 - 第Ｘａ因子解毒剤の凍結乾燥製剤 - Google Patents

第Ｘａ因子解毒剤の凍結乾燥製剤 Download PDF

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JP6742986B2
JP6742986B2 JP2017509739A JP2017509739A JP6742986B2 JP 6742986 B2 JP6742986 B2 JP 6742986B2 JP 2017509739 A JP2017509739 A JP 2017509739A JP 2017509739 A JP2017509739 A JP 2017509739A JP 6742986 B2 JP6742986 B2 JP 6742986B2
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mannitol
formulation
arginine
sucrose
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JP2017525704A5 (enExample
JP2017525704A (ja
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フアン ワン，
フアン ワン，
グレゴリー エー． サチャ，
グレゴリー エー． サチャ，
フォン エム． グエン，
フォン エム． グエン，
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ポートラ ファーマシューティカルズ， インコーポレイテッド
ポートラ ファーマシューティカルズ， インコーポレイテッド
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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
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482—Serine endopeptidases (3.4.21)
    • A61K38/4846—Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • 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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6424—Serine endopeptidases (3.4.21)
    • C12N9/6432—Coagulation factor Xa (3.4.21.6)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21—Serine endopeptidases (3.4.21)
    • C12Y304/21006—Coagulation factor Xa (3.4.21.6)

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  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Molecular Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biomedical Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Dermatology (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
JP2017509739A 2014-08-20 2015-08-20 第Ｘａ因子解毒剤の凍結乾燥製剤 Active JP6742986B2 (ja)

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Application Number Priority Date Filing Date Title
US201462039809P 2014-08-20 2014-08-20
US62/039,809 2014-08-20
PCT/US2015/046173 WO2016029061A1 (en) 2014-08-20 2015-08-20 Lyophilized formulations for factor xa antidote

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JP2017525704A JP2017525704A (ja) 2017-09-07
JP2017525704A5 JP2017525704A5 (enExample) 2018-09-13
JP6742986B2 true JP6742986B2 (ja) 2020-08-19

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JP2017509739A Active JP6742986B2 (ja) 2014-08-20 2015-08-20 第Ｘａ因子解毒剤の凍結乾燥製剤
JP2019165981A Withdrawn JP2019206595A (ja) 2014-08-20 2019-09-12 第Ｘａ因子解毒剤の凍結乾燥製剤
JP2021172975A Active JP7416549B2 (ja) 2014-08-20 2021-10-22 第Ｘａ因子解毒剤の凍結乾燥製剤
JP2023146769A Pending JP2023158199A (ja) 2014-08-20 2023-09-11 第Ｘａ因子解毒剤の凍結乾燥製剤

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JP2021172975A Active JP7416549B2 (ja) 2014-08-20 2021-10-22 第Ｘａ因子解毒剤の凍結乾燥製剤
JP2023146769A Pending JP2023158199A (ja) 2014-08-20 2023-09-11 第Ｘａ因子解毒剤の凍結乾燥製剤

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US (6) US20160237420A1 (enExample)
EP (2) EP3750556A1 (enExample)
JP (4) JP6742986B2 (enExample)
KR (3) KR102867491B1 (enExample)
CN (2) CN113171447B (enExample)
AU (3) AU2015305413B2 (enExample)
CA (1) CA2961739C (enExample)
DK (1) DK3182993T3 (enExample)
EA (2) EA036091B1 (enExample)
ES (1) ES2814157T3 (enExample)
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Cited By (1)

* Cited by examiner, † Cited by third party
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JP2022003101A (ja) * 2014-08-20 2022-01-11 ポートラ ファーマシューティカルズ， インコーポレイテッド 第Ｘａ因子解毒剤の凍結乾燥製剤

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EP3121271B1 (en) * 2009-03-30 2019-07-24 Portola Pharmaceuticals, Inc. Antidotes for factor xa inhibitors and methods of using the same
WO2017147522A1 (en) 2016-02-24 2017-08-31 Portola Pharmaceuticals, Inc. Lyophilized formulations for factor xa antidote
CN110167575B (zh) * 2016-06-17 2024-03-15 阿雷克森制药公司 因子xa衍生物的制备
US11590237B2 (en) * 2017-05-18 2023-02-28 Merck Sharp & Dohme Llc Pharmaceutical formulation comprising incretin-insulin conjugates
TWI840360B (zh) * 2018-05-21 2024-05-01 日商中外製藥股份有限公司 密封於玻璃容器之凍結乾燥的製劑、套組、製造凍結乾燥製劑的方法、防止或減低凍結乾燥製劑的玻璃容器成霧的方法、及容器內面經過硫酸銨處理或ｖｉｓｔ處理之玻璃容器
CN110760479A (zh) * 2019-05-17 2020-02-07 上海交通大学医学院附属瑞金医院 靶向血小板表达的凝血因子Xa及其应用

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EP0675899B1 (en) 1992-12-15 1999-03-17 Corvas International, Inc. NOVEL INHIBITORS OF FACTOR Xa
CZ307715B6 (cs) * 1999-02-22 2019-03-06 University Of Connecticut Způsob lyofilizace vodné farmaceutické formulace faktoru VIII prosté albuminu
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WO2010056765A2 (en) 2008-11-14 2010-05-20 Portola Pharmaceuticals, Inc. Antidotes for factor xa inhibitors and methods of using the same in combination with blood coagulating agents
EP3121271B1 (en) * 2009-03-30 2019-07-24 Portola Pharmaceuticals, Inc. Antidotes for factor xa inhibitors and methods of using the same
JP6163304B2 (ja) * 2009-07-15 2017-07-12 ポートラ ファーマシューティカルズ， インコーポレイテッド 第Ｘａ因子インヒビターの解毒剤の単位用量処方物およびその使用方法
EP2458990B1 (en) * 2009-07-28 2016-03-30 Merck Sharp & Dohme Corp. Methods for producing high concentration lyophilized pharmaceutical formulations
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JP2013544271A (ja) * 2010-12-03 2013-12-12 ポートラ ファーマシューティカルズ， インコーポレイテッド 式（ｉ）の化合物の薬学的組成物、投薬形態、および新規の形態、ならびにその使用方法
CN103945863A (zh) * 2011-08-01 2014-07-23 爱默蕾大学 包含配体的vlp及其相关方法
WO2013049804A1 (en) * 2011-09-30 2013-04-04 The Children's Hospital Of Philadelphia Compositions and methods for modulating hemostasis
GB201310946D0 (en) * 2013-06-19 2013-07-31 Cambridge Entpr Ltd Antidote
EA036091B1 (ru) * 2014-08-20 2020-09-25 Портола Фармасьютикалз, Инк. ВОДНЫЕ СОСТАВЫ АНТИДОТОВ ФАКТОРА Xa (fXa) ДЛЯ ПРЕДУПРЕЖДЕНИЯ ИЛИ УМЕНЬШЕНИЯ КРОВОТЕЧЕНИЯ И ИХ ПРИМЕНЕНИЕ

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2022003101A (ja) * 2014-08-20 2022-01-11 ポートラ ファーマシューティカルズ， インコーポレイテッド 第Ｘａ因子解毒剤の凍結乾燥製剤
JP7416549B2 (ja) 2014-08-20 2024-01-17 ポートラ ファーマシューティカルズ， エルエルシー 第Ｘａ因子解毒剤の凍結乾燥製剤

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ES2814157T3 (es) 2021-03-26
EP3182993A1 (en) 2017-06-28
EA202091385A3 (ru) 2021-06-30
CN107073082B (zh) 2021-04-30
EA201790415A1 (ru) 2017-08-31
KR102867491B1 (ko) 2025-10-01
EP3182993B1 (en) 2020-07-01
EP3750556A1 (en) 2020-12-16
US20160237420A1 (en) 2016-08-18
IL250413A0 (en) 2017-03-30
CN113171447B (zh) 2024-05-17
US20180320160A1 (en) 2018-11-08
CN113171447A (zh) 2021-07-27
AU2015305413A1 (en) 2017-03-23
JP2023158199A (ja) 2023-10-26
AU2020289768B2 (en) 2024-06-13
JP7416549B2 (ja) 2024-01-17
CN107073082A (zh) 2017-08-18
US20250163399A1 (en) 2025-05-22
CA2961739C (en) 2024-04-30
ZA201701764B (en) 2020-10-28
IL250413B (en) 2020-09-30
US11028382B2 (en) 2021-06-08
KR20230007550A (ko) 2023-01-12
IL276960A (en) 2020-10-29
WO2016029061A1 (en) 2016-02-25
EP3182993A4 (en) 2018-01-17
JP2022003101A (ja) 2022-01-11
JP2019206595A (ja) 2019-12-05
KR20170042776A (ko) 2017-04-19
AU2015305413B2 (en) 2020-09-24
KR20250150675A (ko) 2025-10-20
US20210284986A1 (en) 2021-09-16
SG11201701247RA (en) 2017-03-30
DK3182993T3 (da) 2020-09-21
JP2017525704A (ja) 2017-09-07
AU2020289768A1 (en) 2021-01-21
IL276960B (en) 2022-04-01
KR102482517B1 (ko) 2022-12-28
CA2961739A1 (en) 2016-02-25
US20200299667A1 (en) 2020-09-24
US20200299668A1 (en) 2020-09-24
EA202091385A2 (ru) 2021-03-31
AU2024219698A1 (en) 2024-10-03
EA036091B1 (ru) 2020-09-25

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