KR20210054598A - 안정화된 액체 및 동결건조된 ａｄａｍｔｓ13 제제 - Google Patents

안정화된 액체 및 동결건조된 ａｄａｍｔｓ13 제제 Download PDF

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Publication number
KR20210054598A
KR20210054598A KR1020217013486A KR20217013486A KR20210054598A KR 20210054598 A KR20210054598 A KR 20210054598A KR 1020217013486 A KR1020217013486 A KR 1020217013486A KR 20217013486 A KR20217013486 A KR 20217013486A KR 20210054598 A KR20210054598 A KR 20210054598A
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South Korea
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adamts13
formulation
approximately
stabilized
preferred
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Ceased
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KR1020217013486A
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English (en)
Korean (ko)
Inventor
하 페터 마티센
페터 엘 투레섹
한스-페터 슈바르츠
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다케다 야쿠힌 고교 가부시키가이샤
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Priority to KR1020227034508A priority Critical patent/KR20220139456A/ko
Publication of KR20210054598A publication Critical patent/KR20210054598A/ko
Ceased legal-status Critical Current

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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
    • 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
    • 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
    • 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)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Inorganic Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • General Engineering & Computer Science (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Diabetes (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Medicinal Preparation (AREA)
  • Dermatology (AREA)
  • Dispersion Chemistry (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
KR1020217013486A 2009-09-21 2010-09-21 안정화된 액체 및 동결건조된 ａｄａｍｔｓ13 제제 Ceased KR20210054598A (ko)

Priority Applications (1)

Application Number Priority Date Filing Date Title
KR1020227034508A KR20220139456A (ko) 2009-09-21 2010-09-21 안정화된 액체 및 동결건조된 ａｄａｍｔｓ13 제제

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)

Application Number Title Priority Date Filing Date
KR1020197035791A Division KR20190137954A (ko) 2009-09-21 2010-09-21 안정화된 액체 및 동결건조된 ａｄａｍｔｓ13 제제

Related Child Applications (1)

Application Number Title Priority Date Filing Date
KR1020227034508A Division KR20220139456A (ko) 2009-09-21 2010-09-21 안정화된 액체 및 동결건조된 ａｄａｍｔｓ13 제제

Publications (1)

Publication Number Publication Date
KR20210054598A true KR20210054598A (ko) 2021-05-13

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Family Applications (6)

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

Country Link
US (9) US8623352B2 (cg-RX-API-DMAC7.html)
EP (5) EP4218797B9 (cg-RX-API-DMAC7.html)
JP (2) JP5819303B2 (cg-RX-API-DMAC7.html)
KR (6) KR20210054598A (cg-RX-API-DMAC7.html)
CN (2) CN102573792B (cg-RX-API-DMAC7.html)
AU (1) AU2010295299B2 (cg-RX-API-DMAC7.html)
BR (1) BR112012006283B1 (cg-RX-API-DMAC7.html)
CA (1) CA2774556A1 (cg-RX-API-DMAC7.html)
DK (4) DK2480198T3 (cg-RX-API-DMAC7.html)
EA (1) EA024267B1 (cg-RX-API-DMAC7.html)
ES (4) ES2948612T3 (cg-RX-API-DMAC7.html)
FI (2) FI3834841T3 (cg-RX-API-DMAC7.html)
FR (1) FR24C1049I2 (cg-RX-API-DMAC7.html)
HR (1) HRP20160295T1 (cg-RX-API-DMAC7.html)
HU (1) HUE028688T2 (cg-RX-API-DMAC7.html)
IN (1) IN2012DN02645A (cg-RX-API-DMAC7.html)
MX (3) MX362382B (cg-RX-API-DMAC7.html)
NZ (1) NZ598839A (cg-RX-API-DMAC7.html)
PL (4) PL4218797T3 (cg-RX-API-DMAC7.html)
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CN104224705B (zh) 2018-02-02
US20160375111A1 (en) 2016-12-29
US9937244B2 (en) 2018-04-10
KR20220139456A (ko) 2022-10-14
US8623352B2 (en) 2014-01-07
CA2774556A1 (en) 2011-03-24
MX2019000547A (es) 2020-11-12
EP2480198B1 (en) 2016-03-09
DK4218797T5 (da) 2025-07-21
FR24C1049I2 (fr) 2025-12-12
EP4467160A3 (en) 2025-01-15
PL3167897T3 (pl) 2021-09-27
CN102573792A (zh) 2012-07-11
EA201200519A1 (ru) 2012-09-28
EP3834841B1 (en) 2023-05-17
US20200376098A1 (en) 2020-12-03
PL2480198T3 (pl) 2016-09-30
EP2480198A2 (en) 2012-08-01
PL3834841T3 (pl) 2023-07-24
US20140178357A1 (en) 2014-06-26
US20190247475A1 (en) 2019-08-15
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US11564979B2 (en) 2023-01-31
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US20170112906A1 (en) 2017-04-27
BR112012006283A2 (pt) 2016-05-31
NZ598839A (en) 2014-03-28
KR101891646B1 (ko) 2018-08-27
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US10238720B2 (en) 2019-03-26
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