KR20250150675A - 인자 xa 해독제용 동결건조된 제형 - Google Patents

인자 xa 해독제용 동결건조된 제형

Info

Publication number
KR20250150675A
KR20250150675A KR1020257032508A KR20257032508A KR20250150675A KR 20250150675 A KR20250150675 A KR 20250150675A KR 1020257032508 A KR1020257032508 A KR 1020257032508A KR 20257032508 A KR20257032508 A KR 20257032508A KR 20250150675 A KR20250150675 A KR 20250150675A
Authority
KR
South Korea
Prior art keywords
formulation
mannitol
arginine
gly
glu
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
KR1020257032508A
Other languages
English (en)
Korean (ko)
Inventor
쥐안 왕
그레고리 에이 사샤
푸옹 엠 응우옌
Original Assignee
포톨라 파마슈티컬스, 인코포레이티드
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
Application filed by 포톨라 파마슈티컬스, 인코포레이티드 filed Critical 포톨라 파마슈티컬스, 인코포레이티드
Publication of KR20250150675A publication Critical patent/KR20250150675A/ko
Pending legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • 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)

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (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)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biomedical Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Biotechnology (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)
KR1020257032508A 2014-08-20 2015-08-20 인자 xa 해독제용 동결건조된 제형 Pending KR20250150675A (ko)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201462039809P 2014-08-20 2014-08-20
US62/039,809 2014-08-20
KR1020227045749A KR102867491B1 (ko) 2014-08-20 2015-08-20 인자 xa 해독제용 동결건조된 제형
PCT/US2015/046173 WO2016029061A1 (en) 2014-08-20 2015-08-20 Lyophilized formulations for factor xa antidote

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
KR1020227045749A Division KR102867491B1 (ko) 2014-08-20 2015-08-20 인자 xa 해독제용 동결건조된 제형

Publications (1)

Publication Number Publication Date
KR20250150675A true KR20250150675A (ko) 2025-10-20

Family

ID=55351266

Family Applications (3)

Application Number Title Priority Date Filing Date
KR1020257032508A Pending KR20250150675A (ko) 2014-08-20 2015-08-20 인자 xa 해독제용 동결건조된 제형
KR1020227045749A Active KR102867491B1 (ko) 2014-08-20 2015-08-20 인자 xa 해독제용 동결건조된 제형
KR1020177007503A Active KR102482517B1 (ko) 2014-08-20 2015-08-20 인자 xa 해독제용 동결건조된 제형

Family Applications After (2)

Application Number Title Priority Date Filing Date
KR1020227045749A Active KR102867491B1 (ko) 2014-08-20 2015-08-20 인자 xa 해독제용 동결건조된 제형
KR1020177007503A Active KR102482517B1 (ko) 2014-08-20 2015-08-20 인자 xa 해독제용 동결건조된 제형

Country Status (14)

Country Link
US (6) US20160237420A1 (enExample)
EP (2) EP3750556A1 (enExample)
JP (4) JP6742986B2 (enExample)
KR (3) KR20250150675A (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)
IL (2) IL250413B (enExample)
SG (1) SG11201701247RA (enExample)
WO (1) WO2016029061A1 (enExample)
ZA (1) ZA201701764B (enExample)

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PL3604510T3 (pl) * 2009-03-30 2025-07-28 Alexion Pharmaceuticals, Inc. Antidota na inhibitory czynnika xa i sposoby ich stosowania
KR20250150675A (ko) * 2014-08-20 2025-10-20 포톨라 파마슈티컬스, 인코포레이티드 인자 xa 해독제용 동결건조된 제형
CN108883160B (zh) 2016-02-24 2022-06-28 博尔托拉制药公司 因子xa解毒剂的冻干制剂
EP3926044B1 (en) 2016-06-17 2025-06-04 Alexion Pharmaceuticals, Inc. Preparation of factor xa derivatives
EP3624828B1 (en) * 2017-05-18 2024-08-07 Merck Sharp & Dohme LLC Pharmaceutical formulation comprising incretin-insulin conjugates
JP7549530B2 (ja) * 2018-05-21 2024-09-11 中外製薬株式会社 ガラス容器に封入された凍結乾燥製剤
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

Citations (2)

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WO2009042962A2 (en) 2007-09-28 2009-04-02 Portola Pharmaceuticals, Inc. Antidotes for factor xa inhibitors and methods of using the same
WO2011008885A1 (en) 2009-07-15 2011-01-20 Portola Pharmaceuticals, Inc. Unit dose formulation of antidotes for factor xa inhibitors and methods of using the same

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JPH08504769A (ja) 1992-12-15 1996-05-21 コルバス・インターナショナル、インコーポレイテッド 因子Ｘａの新規インヒビター
EP1820516B1 (en) * 1999-02-22 2013-07-24 University of Connecticut Novel albumin-free factor VIII formulations
US6586574B1 (en) * 1999-08-17 2003-07-01 Nn A/S Stabilization of freeze-dried cake
WO2001064642A2 (en) 2000-02-29 2001-09-07 Cor Therapeutics, Inc. Benzamides and related inhibitors of factor xa
US6586584B2 (en) * 2001-01-29 2003-07-01 Becton, Dickinson And Company Sequences and methods for detection of Hepatitis C virus
PT1589949E (pt) * 2003-01-08 2008-11-06 Novartis Vaccines & Diagnostic Composições liofilizadas estabilizadas compreendendo inibidor da coagulação por factores tecidulares ou variante de inibidor da coagulação por factores tecidulares
CN101304971B (zh) 2005-11-08 2011-09-07 米伦纽姆医药公司 Xa因子抑制剂n-(5-氯-2-吡啶基)-2-[[4-[(二甲氨基)亚氨基甲基]苯甲酰基]氨基]-5-甲氧基-苯甲酰胺的医药盐和多晶型
US9283260B2 (en) * 2006-04-21 2016-03-15 Amgen Inc. Lyophilized therapeutic peptibody formulations
KR101691070B1 (ko) 2008-09-03 2016-12-29 옥타파마 아게 재조합에 의해 제조된 인자 ⅷ을 위한 신규한 보호 조성물
CA2743496C (en) * 2008-11-14 2018-03-27 Portola Pharmaceuticals, Inc. Antidotes for factor xa inhibitors and methods of using the same in combination with blood coagulating agents
PL3604510T3 (pl) * 2009-03-30 2025-07-28 Alexion Pharmaceuticals, Inc. Antidota na inhibitory czynnika xa i sposoby ich stosowania
WO2011017070A1 (en) * 2009-07-28 2011-02-10 Merck Sharp & Dohme Corp. Methods for producing high concentration lyophilized pharmaceutical formulations
WO2011088152A1 (en) * 2010-01-12 2011-07-21 Portola Pharmaceuticals, Inc. Pharmaceutical composition and dosage forms of elinogrel and methods of use thereof
CA2796729C (en) * 2010-04-20 2020-06-23 Octapharma Ag Melezitose for stabilizing human blood plasma proteins
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
US9683020B2 (en) * 2011-08-01 2017-06-20 Emory University VLPS containing ligands and methods related thereto
JP6514893B2 (ja) * 2011-09-30 2019-05-15 ザ・チルドレンズ・ホスピタル・オブ・フィラデルフィアＴｈｅ Ｃｈｉｌｄｒｅｎ’Ｓ Ｈｏｓｐｉｔａｌ Ｏｆ Ｐｈｉｌａｄｅｌｐｈｉａ 止血を調節するための組成物および方法
GB201310946D0 (en) * 2013-06-19 2013-07-31 Cambridge Entpr Ltd Antidote
KR20250150675A (ko) * 2014-08-20 2025-10-20 포톨라 파마슈티컬스, 인코포레이티드 인자 xa 해독제용 동결건조된 제형

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009042962A2 (en) 2007-09-28 2009-04-02 Portola Pharmaceuticals, Inc. Antidotes for factor xa inhibitors and methods of using the same
WO2011008885A1 (en) 2009-07-15 2011-01-20 Portola Pharmaceuticals, Inc. Unit dose formulation of antidotes for factor xa inhibitors and methods of using the same

Also Published As

Publication number Publication date
KR20170042776A (ko) 2017-04-19
EA201790415A1 (ru) 2017-08-31
ZA201701764B (en) 2020-10-28
AU2020289768A1 (en) 2021-01-21
EA202091385A3 (ru) 2021-06-30
IL276960B (en) 2022-04-01
EA202091385A2 (ru) 2021-03-31
EP3182993A1 (en) 2017-06-28
CN107073082A (zh) 2017-08-18
IL250413A0 (en) 2017-03-30
US20210284986A1 (en) 2021-09-16
KR102482517B1 (ko) 2022-12-28
SG11201701247RA (en) 2017-03-30
IL250413B (en) 2020-09-30
DK3182993T3 (da) 2020-09-21
JP2023158199A (ja) 2023-10-26
US20180320160A1 (en) 2018-11-08
CA2961739A1 (en) 2016-02-25
JP2022003101A (ja) 2022-01-11
AU2020289768B2 (en) 2024-06-13
EP3182993A4 (en) 2018-01-17
EA036091B1 (ru) 2020-09-25
US11028382B2 (en) 2021-06-08
US20250163399A1 (en) 2025-05-22
CN113171447B (zh) 2024-05-17
US20200299667A1 (en) 2020-09-24
EP3182993B1 (en) 2020-07-01
AU2015305413B2 (en) 2020-09-24
JP2019206595A (ja) 2019-12-05
AU2015305413A1 (en) 2017-03-23
CA2961739C (en) 2024-04-30
JP2017525704A (ja) 2017-09-07
KR20230007550A (ko) 2023-01-12
US20160237420A1 (en) 2016-08-18
CN107073082B (zh) 2021-04-30
JP6742986B2 (ja) 2020-08-19
AU2024219698A1 (en) 2024-10-03
WO2016029061A1 (en) 2016-02-25
KR102867491B1 (ko) 2025-10-01
JP7416549B2 (ja) 2024-01-17
ES2814157T3 (es) 2021-03-26
CN113171447A (zh) 2021-07-27
EP3750556A1 (en) 2020-12-16
IL276960A (en) 2020-10-29
US20200299668A1 (en) 2020-09-24

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