ES2814157T3 - Formulaciones liofilizadas para antídoto del factor Xa - Google Patents

Formulaciones liofilizadas para antídoto del factor Xa Download PDF

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Publication number
ES2814157T3
ES2814157T3 ES15834421T ES15834421T ES2814157T3 ES 2814157 T3 ES2814157 T3 ES 2814157T3 ES 15834421 T ES15834421 T ES 15834421T ES 15834421 T ES15834421 T ES 15834421T ES 2814157 T3 ES2814157 T3 ES 2814157T3
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Spain
Prior art keywords
formulation
mannitol
arginine
sucrose
seq
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Application number
ES15834421T
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English (en)
Spanish (es)
Inventor
Juan Wang
Gregory A Sacha
Phuong M Nguyen
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Portola Pharmaceuticals LLC
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Portola Pharmaceuticals LLC
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Publication of ES2814157T3 publication Critical patent/ES2814157T3/es
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    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14Hydrolases (3)
    • C12N9/48Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6424Serine endopeptidases (3.4.21)
    • C12N9/6432Coagulation factor Xa (3.4.21.6)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36Blood coagulation or fibrinolysis factors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482Serine endopeptidases (3.4.21)
    • A61K38/4846Factor 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)
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • 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
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/08Solutions
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y304/00Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21Serine endopeptidases (3.4.21)
    • C12Y304/21006Coagulation 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)
  • 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)
ES15834421T 2014-08-20 2015-08-20 Formulaciones liofilizadas para antídoto del factor Xa Active ES2814157T3 (es)

Applications Claiming Priority (2)

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

Publications (1)

Publication Number Publication Date
ES2814157T3 true ES2814157T3 (es) 2021-03-26

Family

ID=55351266

Family Applications (1)

Application Number Title Priority Date Filing Date
ES15834421T Active ES2814157T3 (es) 2014-08-20 2015-08-20 Formulaciones liofilizadas para antídoto del factor Xa

Country Status (14)

Country Link
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)
IL (2) IL250413B (enExample)
SG (1) SG11201701247RA (enExample)
WO (1) WO2016029061A1 (enExample)
ZA (1) ZA201701764B (enExample)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3121271B1 (en) * 2009-03-30 2019-07-24 Portola Pharmaceuticals, Inc. Antidotes for factor xa inhibitors and methods of using the same
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
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

Family Cites Families (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
US6586574B1 (en) * 1999-08-17 2003-07-01 Nn A/S Stabilization of freeze-dried cake
AU2001245353A1 (en) 2000-02-29 2001-09-12 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
JP2008500942A (ja) * 2003-01-08 2008-01-17 カイロン コーポレイション 組織因子経路インヒビターまたは組織因子経路インヒビター改変体を含有する安定化凍結乾燥組成物
CN102336702B (zh) 2005-11-08 2015-02-11 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
JO3324B1 (ar) * 2006-04-21 2019-03-13 Amgen Inc مركبات علاجية مجففة بالتبريد تتعلق بالعصارة الهضمية
PL2915564T3 (pl) * 2007-09-28 2021-07-19 Alexion Pharmaceuticals, Inc. Antidota dla inhibitorów czynnika Xa i sposoby ich stosowania
PL2337580T3 (pl) 2008-09-03 2012-08-31 Octapharma Ag Stabilizowane kompozycje czynnika VIII produkowanego metodami rekombinacji genetycznej
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
US20130165459A1 (en) * 2010-01-12 2013-06-27 Norvartis Pharma Ag Pharmaceutical composition and dosage forms of elinogrel and methods of use thereof
DK2561070T3 (en) * 2010-04-20 2015-08-17 Octapharma Ag NEW STABILIZER FOR PHARMACEUTICAL 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
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

Also Published As

Publication number Publication date
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
JP6742986B2 (ja) 2020-08-19
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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