FR24C1049I2 - Formulations liquides et lyophilisées stabilisées de adamts13 - Google Patents

Formulations liquides et lyophilisées stabilisées de adamts13

Info

Publication number
FR24C1049I2
FR24C1049I2 FR24C1049C FR24C1049C FR24C1049I2 FR 24C1049 I2 FR24C1049 I2 FR 24C1049I2 FR 24C1049 C FR24C1049 C FR 24C1049C FR 24C1049 C FR24C1049 C FR 24C1049C FR 24C1049 I2 FR24C1049 I2 FR 24C1049I2
Authority
FR
France
Prior art keywords
adamts13
freeze
stabilized liquid
dried formulations
formulations
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.)
Active
Application number
FR24C1049C
Other languages
English (en)
French (fr)
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Takeda Pharmaceutical Co Ltd
Original Assignee
Takeda Pharmaceutical Co Ltd
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 Co Ltd filed Critical Takeda Pharmaceutical Co Ltd
Publication of FR24C1049I1 publication Critical patent/FR24C1049I1/fr
Application granted granted Critical
Publication of FR24C1049I2 publication Critical patent/FR24C1049I2/fr
Active legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • 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
    • 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
    • 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)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (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)
  • Immunology (AREA)
  • Inorganic Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Molecular Biology (AREA)
  • Wood Science & Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Zoology (AREA)
  • Genetics & Genomics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Hematology (AREA)
  • Cardiology (AREA)
  • Diabetes (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Medicinal Preparation (AREA)
  • Dispersion Chemistry (AREA)
  • Dermatology (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)
FR24C1049C 2009-09-21 2024-12-10 Formulations liquides et lyophilisées stabilisées de adamts13 Active FR24C1049I2 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US24435309P 2009-09-21 2009-09-21
EP10759786.6A EP2480198B9 (en) 2009-09-21 2010-09-21 Stabilized liquid and lyophilized adamts13 formulations
PCT/US2010/049723 WO2011035335A2 (en) 2009-09-21 2010-09-21 Stabilized liquid and lyophilized adamts13 formulations
EP15203085.4A EP3167897B1 (en) 2009-09-21 2010-09-21 Stabilized liquid and lyophilized adamts13 formulations

Publications (2)

Publication Number Publication Date
FR24C1049I1 FR24C1049I1 (fr) 2025-01-17
FR24C1049I2 true FR24C1049I2 (fr) 2025-12-12

Family

ID=43598388

Family Applications (1)

Application Number Title Priority Date Filing Date
FR24C1049C Active FR24C1049I2 (fr) 2009-09-21 2024-12-10 Formulations liquides et lyophilisées stabilisées de adamts13

Country Status (21)

Country Link
US (9) US8623352B2 (en:Method)
EP (5) EP3834841B1 (en:Method)
JP (2) JP5819303B2 (en:Method)
KR (6) KR20220139456A (en:Method)
CN (2) CN104224705B (en:Method)
AU (1) AU2010295299B2 (en:Method)
BR (1) BR112012006283B1 (en:Method)
CA (1) CA2774556A1 (en:Method)
DK (4) DK3834841T3 (en:Method)
EA (1) EA024267B1 (en:Method)
ES (4) ES3001509T3 (en:Method)
FI (2) FI4218797T3 (en:Method)
FR (1) FR24C1049I2 (en:Method)
HR (1) HRP20160295T1 (en:Method)
HU (1) HUE028688T2 (en:Method)
IN (1) IN2012DN02645A (en:Method)
MX (3) MX362382B (en:Method)
NZ (1) NZ598839A (en:Method)
PL (4) PL3167897T3 (en:Method)
PT (2) PT4218797T (en:Method)
WO (1) WO2011035335A2 (en:Method)

Families Citing this family (21)

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WO2010065742A1 (en) 2008-12-05 2010-06-10 Baxter International Inc. Methods of measuring adamts13-mediated in vivo cleavage of von willebrand factor and uses thereof
JP5819303B2 (ja) 2009-09-21 2015-11-24 バクスター・インターナショナル・インコーポレイテッドBaxter International Incorp0Rated 安定化された液体および凍結乾燥adamts13製剤
EP3311847A1 (en) * 2012-02-16 2018-04-25 Atyr Pharma, Inc. Histidyl-trna synthetases for treating autoimmune and inflammatory diseases
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
WO2014075033A2 (en) 2012-11-09 2014-05-15 Puget Sound Blood Center Protein stabilizing factors
EP2970921B1 (en) 2013-03-15 2018-09-19 aTyr Pharma, Inc. Histidyl-trna synthetase-fc conjugates
AU2013203062C1 (en) 2013-03-15 2018-06-28 Takeda Pharmaceutical Company Limited Subcutaneous administration of adamts13
US20170209582A1 (en) * 2014-06-26 2017-07-27 Amgen Inc. Protein formulations
GB201510870D0 (en) * 2015-05-26 2015-08-05 Baxalta Inc And Katholieke Universiteit Leuven And Baxalta Gmbh Treatment of infarction
ES2983978T3 (es) 2016-01-08 2024-10-28 Univ Kyoto Medicina que comprende ADAMTS13 como ingrediente principal
MX2019001255A (es) 2016-08-04 2019-05-20 Baxalta Inc Uso de una desintegrina y metaloproteinasa con motivo tipo 1 de trombospondina, miembro-13 (adamts13) para tratar, mejorar y/o prevenir crisis vaso-oclusiva en enfermedad de celulas falciformes, lesion pulmonar aguda y/o sindrome de insuficiencia respiratoria aguda.
AU2017391165B2 (en) 2016-11-04 2023-02-02 Takeda Pharmaceutical Company Limited Adeno-associated virus formulations
US11767520B2 (en) 2017-04-20 2023-09-26 Atyr Pharma, Inc. Compositions and methods for treating lung inflammation
US11273205B2 (en) * 2017-07-25 2022-03-15 Jiangsu Hengrui Medicine Co., Ltd. IL-15 protein complex pharmaceutical composition
CN112469427A (zh) * 2018-07-11 2021-03-09 百特奥尔塔公司 Aav组合物
US20220339266A1 (en) 2019-10-04 2022-10-27 The Children's Medical Center Corporation Adamts13 treatment to enhance graft survival
KR20230005192A (ko) 2020-04-02 2023-01-09 다케다 야쿠힌 고교 가부시키가이샤 Adamts13 변이체, 조성물 및 그의 용도
US20230201319A1 (en) 2020-05-22 2023-06-29 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
EP4490042A1 (en) 2022-03-08 2025-01-15 Equashield Medical Ltd. Fluid transfer station in a robotic pharmaceutical preparation system
KR20240112755A (ko) * 2023-01-11 2024-07-19 주식회사 녹십자 혈전성 질환의 예방 또는 치료를 위한 신규한 액상 제형물

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KR100472006B1 (ko) 2002-10-09 2005-03-10 동부아남반도체 주식회사 모스 트랜지스터 제조 방법
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
GB0404693D0 (en) * 2004-03-02 2004-04-07 Univ London Pharmaceutical preparations for the treatment of ocular surface and other disorders
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JP4880997B2 (ja) * 2005-12-28 2012-02-22 アルフレッサファーマ株式会社 Adamts13の安定化方法
KR101422435B1 (ko) 2006-01-04 2014-07-22 박스터 헬쓰케어 에스에이 올리고펩티드-무함유 세포 배양 배지
JP5819303B2 (ja) * 2009-09-21 2015-11-24 バクスター・インターナショナル・インコーポレイテッドBaxter International Incorp0Rated 安定化された液体および凍結乾燥adamts13製剤
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
PT4218797T (pt) 2024-12-09
KR20120099646A (ko) 2012-09-11
WO2011035335A2 (en) 2011-03-24
US20200376098A1 (en) 2020-12-03
DK3167897T3 (da) 2021-04-19
CN102573792A (zh) 2012-07-11
NZ598839A (en) 2014-03-28
KR20180095738A (ko) 2018-08-27
US20110229455A1 (en) 2011-09-22
US10758599B2 (en) 2020-09-01
EP2480198B9 (en) 2016-11-23
CN104224705A (zh) 2014-12-24
MX362382B (es) 2019-01-14
JP2013505270A (ja) 2013-02-14
KR20210054598A (ko) 2021-05-13
FR24C1049I1 (fr) 2025-01-17
KR101891646B1 (ko) 2018-08-27
US10238720B2 (en) 2019-03-26
PL4218797T3 (pl) 2025-02-10
US11564979B2 (en) 2023-01-31
EP4467160A2 (en) 2024-11-27
MX2019000547A (es) 2020-11-12
CA2774556A1 (en) 2011-03-24
AU2010295299B2 (en) 2015-12-24
US20140178357A1 (en) 2014-06-26
EP2480198A2 (en) 2012-08-01
CN102573792B (zh) 2014-10-15
BR112012006283A2 (pt) 2016-05-31
US20190247475A1 (en) 2019-08-15
KR20190137954A (ko) 2019-12-11
ES2865250T3 (es) 2021-10-15
IN2012DN02645A (en:Method) 2015-09-11
MX339205B (es) 2016-05-16
EA201200519A1 (ru) 2012-09-28
EP3834841B1 (en) 2023-05-17
US20250099559A1 (en) 2025-03-27
DK3834841T3 (da) 2023-06-06
AU2010295299A1 (en) 2012-04-12
US9937244B2 (en) 2018-04-10
ES2579906T3 (es) 2016-08-17
EP3167897A1 (en) 2017-05-17
KR20220139456A (ko) 2022-10-14
FI3834841T3 (fi) 2023-06-05
US12178861B2 (en) 2024-12-31
JP2015063556A (ja) 2015-04-09
US8623352B2 (en) 2014-01-07
US20170112906A1 (en) 2017-04-27
HK1173968A1 (zh) 2013-05-31
US20230130866A1 (en) 2023-04-27
US20180207245A1 (en) 2018-07-26
CN104224705B (zh) 2018-02-02
DK4218797T5 (da) 2025-07-21
EP2480198B1 (en) 2016-03-09
DK4218797T3 (da) 2024-12-09
PL2480198T3 (pl) 2016-09-30
EA024267B1 (ru) 2016-09-30
PL3834841T3 (pl) 2023-07-24
HRP20160295T1 (hr) 2016-05-20
PL3167897T3 (pl) 2021-09-27
JP5819303B2 (ja) 2015-11-24
ES2948612T3 (es) 2023-09-14
US20160375111A1 (en) 2016-12-29
WO2011035335A3 (en) 2011-12-01
ES3001509T3 (en) 2025-03-05
FI4218797T3 (fi) 2024-12-07
BR112012006283B1 (pt) 2022-03-15
MX2012003414A (es) 2012-06-19
EP4218797B1 (en) 2024-09-11
EP3167897B1 (en) 2021-01-27
EP4218797A1 (en) 2023-08-02
PT3834841T (pt) 2023-06-19
HUE028688T2 (en) 2017-01-30
EP4467160A3 (en) 2025-01-15
US9351935B2 (en) 2016-05-31
KR20250008986A (ko) 2025-01-16
EP4218797B9 (en) 2025-04-30
US9572778B2 (en) 2017-02-21
DK2480198T3 (en) 2016-03-29
EP3834841A1 (en) 2021-06-16

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