KR20190137954A - 안정화된 액체 및 동결건조된 ａｄａｍｔｓ13 제제 - Google Patents

안정화된 액체 및 동결건조된 ａｄａｍｔｓ13 제제 Download PDF

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Publication number
KR20190137954A
KR20190137954A KR1020197035791A KR20197035791A KR20190137954A KR 20190137954 A KR20190137954 A KR 20190137954A KR 1020197035791 A KR1020197035791 A KR 1020197035791A KR 20197035791 A KR20197035791 A KR 20197035791A KR 20190137954 A KR20190137954 A KR 20190137954A
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South Korea
Prior art keywords
adamts13
formulation
stabilized
preferred
units
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Korean (ko)
Inventor
하 페터 마티센
페터 엘 투레섹
한스-페터 슈바르츠
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박스알타 인코퍼레이티드
박스앨타 게엠베하
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Publication of KR20190137954A publication Critical patent/KR20190137954A/ko
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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
    • A61K9/10—Dispersions; Emulsions
    • 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)
    • A61K38/4886—Metalloendopeptidases (3.4.24), e.g. collagenase
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K9/08—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • 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)
    • C12Y304/24—Metalloendopeptidases (3.4.24)
    • C12Y304/24087—ADAMTS13 endopeptidase (3.4.24.87)
    • 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
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Inorganic Chemistry (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • General Engineering & Computer Science (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Genetics & Genomics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Diabetes (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Medicinal Preparation (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Dispersion Chemistry (AREA)
  • Dermatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
KR1020197035791A 2009-09-21 2010-09-21 안정화된 액체 및 동결건조된 ａｄａｍｔｓ13 제제 Ceased KR20190137954A (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US24435309P 2009-09-21 2009-09-21
US61/244,353 2009-09-21
PCT/US2010/049723 WO2011035335A2 (en) 2009-09-21 2010-09-21 Stabilized liquid and lyophilized adamts13 formulations

Related Parent Applications (1)

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KR1020187023806A Division KR20180095738A (ko) 2009-09-21 2010-09-21 안정화된 액체 및 동결건조된 ａｄａｍｔｓ13 제제

Related Child Applications (1)

Application Number Title Priority Date Filing Date
KR1020217013486A Division KR20210054598A (ko) 2009-09-21 2010-09-21 안정화된 액체 및 동결건조된 ａｄａｍｔｓ13 제제

Publications (1)

Publication Number Publication Date
KR20190137954A true KR20190137954A (ko) 2019-12-11

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ID=43598388

Family Applications (6)

Application Number Title Priority Date Filing Date
KR1020197035791A Ceased KR20190137954A (ko) 2009-09-21 2010-09-21 안정화된 액체 및 동결건조된 ａｄａｍｔｓ13 제제
KR1020127009803A Active KR101891646B1 (ko) 2009-09-21 2010-09-21 안정화된 액체 및 동결건조된 ａｄａｍｔｓ13 제제
KR1020187023806A Ceased KR20180095738A (ko) 2009-09-21 2010-09-21 안정화된 액체 및 동결건조된 ａｄａｍｔｓ13 제제
KR1020217013486A Ceased KR20210054598A (ko) 2009-09-21 2010-09-21 안정화된 액체 및 동결건조된 ａｄａｍｔｓ13 제제
KR1020247043292A Pending KR20250008986A (ko) 2009-09-21 2010-09-21 안정화된 액체 및 동결건조된 ａｄａｍｔｓ13 제제
KR1020227034508A Ceased KR20220139456A (ko) 2009-09-21 2010-09-21 안정화된 액체 및 동결건조된 ａｄａｍｔｓ13 제제

Family Applications After (5)

Application Number Title Priority Date Filing Date
KR1020127009803A Active KR101891646B1 (ko) 2009-09-21 2010-09-21 안정화된 액체 및 동결건조된 ａｄａｍｔｓ13 제제
KR1020187023806A Ceased KR20180095738A (ko) 2009-09-21 2010-09-21 안정화된 액체 및 동결건조된 ａｄａｍｔｓ13 제제
KR1020217013486A Ceased KR20210054598A (ko) 2009-09-21 2010-09-21 안정화된 액체 및 동결건조된 ａｄａｍｔｓ13 제제
KR1020247043292A Pending KR20250008986A (ko) 2009-09-21 2010-09-21 안정화된 액체 및 동결건조된 ａｄａｍｔｓ13 제제
KR1020227034508A Ceased KR20220139456A (ko) 2009-09-21 2010-09-21 안정화된 액체 및 동결건조된 ａｄａｍｔｓ13 제제

Country Status (21)

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US (9) US8623352B2 (enExample)
EP (5) EP3167897B1 (enExample)
JP (2) JP5819303B2 (enExample)
KR (6) KR20190137954A (enExample)
CN (2) CN104224705B (enExample)
AU (1) AU2010295299B2 (enExample)
BR (1) BR112012006283B1 (enExample)
CA (1) CA2774556A1 (enExample)
DK (4) DK3834841T3 (enExample)
EA (1) EA024267B1 (enExample)
ES (4) ES2865250T3 (enExample)
FI (2) FI3834841T3 (enExample)
FR (1) FR24C1049I1 (enExample)
HR (1) HRP20160295T1 (enExample)
HU (1) HUE028688T2 (enExample)
IN (1) IN2012DN02645A (enExample)
MX (3) MX362382B (enExample)
NZ (1) NZ598839A (enExample)
PL (4) PL2480198T3 (enExample)
PT (2) PT4218797T (enExample)
WO (1) WO2011035335A2 (enExample)

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NZ750146A (en) * 2016-08-04 2025-10-31 Takeda Pharmaceuticals Co Use of adamts13 for treating, ameliorating and/or preventing vaso-occlusive crisis in sickle cell disease, acute lung injury and/or acute respiratory distress syndrome
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AU2021248679A1 (en) 2020-04-02 2022-10-27 Takeda Pharmaceutical Company Limited ADAMTS13 variant, compositions, and uses thereof
WO2021234458A1 (en) 2020-05-22 2021-11-25 Takeda Pharmaceutical Company Limited Adamts13 compositions and methods for treating and diagnosing complications of coronavirus disease
IL300596A (en) * 2020-08-13 2023-04-01 Hadasit Medical Res Services & Development Limited Mutants of disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (adamts-13), preparations and their uses in therapeutic methods
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WO2024151093A1 (ko) * 2023-01-11 2024-07-18 주식회사 녹십자 혈전성 질환의 예방 또는 치료를 위한 신규한 액상 제형물

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CN104224705B (zh) 2018-02-02
AU2010295299B2 (en) 2015-12-24
NZ598839A (en) 2014-03-28
MX2019000547A (es) 2020-11-12
DK4218797T3 (da) 2024-12-09
CA2774556A1 (en) 2011-03-24
KR20120099646A (ko) 2012-09-11
DK3834841T3 (da) 2023-06-06
FR24C1049I1 (fr) 2025-01-17
US20180207245A1 (en) 2018-07-26
US20230130866A1 (en) 2023-04-27
MX2012003414A (es) 2012-06-19
US9572778B2 (en) 2017-02-21
KR20210054598A (ko) 2021-05-13
HRP20160295T1 (hr) 2016-05-20
HK1173968A1 (zh) 2013-05-31
MX362382B (es) 2019-01-14
DK4218797T5 (da) 2025-07-21
CN104224705A (zh) 2014-12-24
BR112012006283B1 (pt) 2022-03-15
IN2012DN02645A (enExample) 2015-09-11
EP4218797B1 (en) 2024-09-11
PT3834841T (pt) 2023-06-19
ES3001509T3 (en) 2025-03-05
US11564979B2 (en) 2023-01-31
DK2480198T3 (en) 2016-03-29
US9937244B2 (en) 2018-04-10
BR112012006283A2 (pt) 2016-05-31
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