PL3834841T3 - Stabilizowane ciekłe i liofilizowane preparaty adamts13 - Google Patents

Stabilizowane ciekłe i liofilizowane preparaty adamts13

Info

Publication number
PL3834841T3
PL3834841T3 PL20211228.0T PL20211228T PL3834841T3 PL 3834841 T3 PL3834841 T3 PL 3834841T3 PL 20211228 T PL20211228 T PL 20211228T PL 3834841 T3 PL3834841 T3 PL 3834841T3
Authority
PL
Poland
Prior art keywords
stabilized liquid
adamts13 formulations
lyophilized adamts13
lyophilized
formulations
Prior art date
Application number
PL20211228.0T
Other languages
English (en)
Polish (pl)
Inventor
H. Peter Matthiessen
Peter Turecek
Hans-Peter Schwarz
Original Assignee
Takeda Pharmaceutical Company Limited
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 Takeda Pharmaceutical Company Limited filed Critical Takeda Pharmaceutical Company Limited
Publication of PL3834841T3 publication Critical patent/PL3834841T3/pl

Links

Classifications

    • 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
    • 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)
    • A61K38/4886Metalloendopeptidases (3.4.24), e.g. collagenase
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K9/08Solutions
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs 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
    • 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)
    • C12Y304/24Metalloendopeptidases (3.4.24)
    • C12Y304/24087ADAMTS13 endopeptidase (3.4.24.87)
    • 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
    • YGENERAL 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
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (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)
  • Immunology (AREA)
  • Inorganic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • General Engineering & Computer Science (AREA)
  • Zoology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (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)
  • Peptides Or Proteins (AREA)
PL20211228.0T 2009-09-21 2010-09-21 Stabilizowane ciekłe i liofilizowane preparaty adamts13 PL3834841T3 (pl)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US24435309P 2009-09-21 2009-09-21

Publications (1)

Publication Number Publication Date
PL3834841T3 true PL3834841T3 (pl) 2023-07-24

Family

ID=43598388

Family Applications (4)

Application Number Title Priority Date Filing Date
PL20211228.0T PL3834841T3 (pl) 2009-09-21 2010-09-21 Stabilizowane ciekłe i liofilizowane preparaty adamts13
PL10759786.6T PL2480198T3 (pl) 2009-09-21 2010-09-21 Stabilizowane płynne i liofilizowane preparaty adamts13
PL23172759.5T PL4218797T3 (pl) 2009-09-21 2010-09-21 Stabilizowane płynne i liofilizowane preparaty adamts13
PL15203085T PL3167897T3 (pl) 2009-09-21 2010-09-21 Stabilizowane płynne i liofilizowane preparaty adamts13

Family Applications After (3)

Application Number Title Priority Date Filing Date
PL10759786.6T PL2480198T3 (pl) 2009-09-21 2010-09-21 Stabilizowane płynne i liofilizowane preparaty adamts13
PL23172759.5T PL4218797T3 (pl) 2009-09-21 2010-09-21 Stabilizowane płynne i liofilizowane preparaty adamts13
PL15203085T PL3167897T3 (pl) 2009-09-21 2010-09-21 Stabilizowane płynne i liofilizowane preparaty adamts13

Country Status (21)

Country Link
US (9) US8623352B2 (instruction)
EP (5) EP4467160A3 (instruction)
JP (2) JP5819303B2 (instruction)
KR (6) KR20220139456A (instruction)
CN (2) CN102573792B (instruction)
AU (1) AU2010295299B2 (instruction)
BR (1) BR112012006283B1 (instruction)
CA (1) CA2774556A1 (instruction)
DK (4) DK2480198T3 (instruction)
EA (1) EA024267B1 (instruction)
ES (4) ES2579906T3 (instruction)
FI (2) FI4218797T3 (instruction)
FR (1) FR24C1049I1 (instruction)
HR (1) HRP20160295T1 (instruction)
HU (1) HUE028688T2 (instruction)
IN (1) IN2012DN02645A (instruction)
MX (3) MX339205B (instruction)
NZ (1) NZ598839A (instruction)
PL (4) PL3834841T3 (instruction)
PT (2) PT3834841T (instruction)
WO (1) WO2011035335A2 (instruction)

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US8415114B2 (en) 2008-12-05 2013-04-09 Baxter International Inc. Methods of measuring ADAMTS13-mediated in vivo cleavage of von Willebrand factor and uses thereof
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IN2014MN01642A (instruction) * 2012-02-16 2015-07-03 Atyr Pharma Inc
CN103566362B (zh) * 2012-07-21 2015-07-29 复旦大学 重组adamts13在制备脑出血药物中的用途
US10441531B2 (en) * 2012-11-09 2019-10-15 Bloodworks Protein stabilizing factors
EP3460054B1 (en) 2013-03-15 2020-10-21 aTyr Pharma, Inc. Histidyl-trna synthetase-fc conjugates
AU2013203062C1 (en) * 2013-03-15 2018-06-28 Takeda Pharmaceutical Company Limited Subcutaneous administration of adamts13
AU2015280480A1 (en) * 2014-06-26 2017-01-05 Amgen Inc. Protein formulations
GB201510870D0 (en) * 2015-05-26 2015-08-05 Baxalta Inc And Katholieke Universiteit Leuven And Baxalta Gmbh Treatment of infarction
US11567080B2 (en) 2016-01-08 2023-01-31 Kyoto University Diagnostic agent and medicine comprising ADAMTS13 as main ingredient
KR102537083B1 (ko) 2016-08-04 2023-05-25 다케다 파머수티컬 컴패니 리미티드 겸상적혈구병, 급성 폐 손상 및/또는 급성 호흡 곤란 증후군에서 혈관폐색 위기의 치료, 개선, 및/또는 예방을 위한 adamts13의 용도
PT3534922T (pt) 2016-11-04 2024-06-07 Takeda Pharmaceuticals Co Formulações de vírus adenoassociado
EP3612215B1 (en) 2017-04-20 2024-08-28 aTyr Pharma, Inc. Compositions for treating lung inflammation
PL3639845T3 (pl) * 2017-07-25 2023-10-23 Jiangsu Hengrui Medicine Co., Ltd. Kompozycja farmaceutyczna zawierająca kompleks białka il-15 i jej zastosowania
BR112021000327A2 (pt) * 2018-07-11 2021-04-06 Baxalta Incorporated Composições de aav
WO2021067668A1 (en) 2019-10-04 2021-04-08 The Children's Medical Center Corporation Adamts13 treatment to enhance graft survival
AU2021248679A1 (en) 2020-04-02 2022-10-27 Takeda Pharmaceutical Company Limited ADAMTS13 variant, compositions, and uses thereof
EP4153215A1 (en) 2020-05-22 2023-03-29 Takeda Pharmaceutical Company Limited Adamts13 compositions and methods for treating and diagnosing complications of coronavirus disease
EP4196147A4 (en) * 2020-08-13 2024-08-21 Hadasit Medical Research Services and Development Ltd. DISINTEGRIN AND METALLOPROTEINASE WITH THROMBOSPONDIN TYPE 1 MOTIF, MUTANTS OF ELEMENT 13 (ADAMTS-13), COMPOSITIONS AND THERAPEUTIC METHODS THEREFOR
CN119173446A (zh) 2022-03-08 2024-12-20 赤盾医疗有限公司 机器人药物制备系统中的流体转移站
KR20240112755A (ko) * 2023-01-11 2024-07-19 주식회사 녹십자 혈전성 질환의 예방 또는 치료를 위한 신규한 액상 제형물

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US7780831B2 (en) * 2003-07-07 2010-08-24 The University Of North Carolina At Chapel Hill Assays for detection of von willebrand factor (vWF) multimers and for degradation of vWF by agents such as ADAMTS13 and related methods
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US8823352B2 (en) 2011-07-11 2014-09-02 Linear Technology Corporation Switching power supply having separate AC and DC current sensing paths

Also Published As

Publication number Publication date
KR20210054598A (ko) 2021-05-13
JP2013505270A (ja) 2013-02-14
IN2012DN02645A (instruction) 2015-09-11
PL3167897T3 (pl) 2021-09-27
JP5819303B2 (ja) 2015-11-24
PL4218797T3 (pl) 2025-02-10
US20140178357A1 (en) 2014-06-26
ES2579906T3 (es) 2016-08-17
KR20220139456A (ko) 2022-10-14
FI4218797T3 (fi) 2024-12-07
US9351935B2 (en) 2016-05-31
EP3834841B1 (en) 2023-05-17
HUE028688T2 (en) 2017-01-30
DK3834841T3 (da) 2023-06-06
EA024267B1 (ru) 2016-09-30
HK1173968A1 (zh) 2013-05-31
EP4467160A3 (en) 2025-01-15
KR20120099646A (ko) 2012-09-11
US10758599B2 (en) 2020-09-01
MX362382B (es) 2019-01-14
HRP20160295T1 (hr) 2016-05-20
EP2480198B9 (en) 2016-11-23
US20180207245A1 (en) 2018-07-26
PT4218797T (pt) 2024-12-09
US20250099559A1 (en) 2025-03-27
NZ598839A (en) 2014-03-28
US20190247475A1 (en) 2019-08-15
MX2019000547A (es) 2020-11-12
US8623352B2 (en) 2014-01-07
DK3167897T3 (da) 2021-04-19
EP3167897B1 (en) 2021-01-27
WO2011035335A3 (en) 2011-12-01
MX339205B (es) 2016-05-16
KR20250008986A (ko) 2025-01-16
US20170112906A1 (en) 2017-04-27
JP2015063556A (ja) 2015-04-09
CN102573792A (zh) 2012-07-11
US9572778B2 (en) 2017-02-21
KR20180095738A (ko) 2018-08-27
US20200376098A1 (en) 2020-12-03
EP2480198A2 (en) 2012-08-01
DK2480198T3 (en) 2016-03-29
AU2010295299A1 (en) 2012-04-12
PL2480198T3 (pl) 2016-09-30
EP4218797B9 (en) 2025-04-30
CN102573792B (zh) 2014-10-15
US10238720B2 (en) 2019-03-26
FI3834841T3 (fi) 2023-06-05
KR101891646B1 (ko) 2018-08-27
EP4467160A2 (en) 2024-11-27
EP3834841A1 (en) 2021-06-16
CN104224705B (zh) 2018-02-02
ES2865250T3 (es) 2021-10-15
KR20190137954A (ko) 2019-12-11
EP2480198B1 (en) 2016-03-09
DK4218797T3 (da) 2024-12-09
EP4218797B1 (en) 2024-09-11
WO2011035335A2 (en) 2011-03-24
ES3001509T3 (en) 2025-03-05
CA2774556A1 (en) 2011-03-24
EA201200519A1 (ru) 2012-09-28
ES2948612T3 (es) 2023-09-14
US20110229455A1 (en) 2011-09-22
US11564979B2 (en) 2023-01-31
FR24C1049I1 (fr) 2025-01-17
BR112012006283B1 (pt) 2022-03-15
CN104224705A (zh) 2014-12-24
US20160375111A1 (en) 2016-12-29
US12178861B2 (en) 2024-12-31
EP3167897A1 (en) 2017-05-17
US9937244B2 (en) 2018-04-10
EP4218797A1 (en) 2023-08-02
MX2012003414A (es) 2012-06-19
US20230130866A1 (en) 2023-04-27
BR112012006283A2 (pt) 2016-05-31
PT3834841T (pt) 2023-06-19
AU2010295299B2 (en) 2015-12-24
DK4218797T5 (da) 2025-07-21

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