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ECSP13013010A - Preparación de gadobutrol de alta pureza - Google Patents

Preparación de gadobutrol de alta pureza

Info

Publication number
ECSP13013010A
ECSP13013010A ECSP13013010A ECSP13013010A EC SP13013010 A ECSP13013010 A EC SP13013010A EC SP13013010 A ECSP13013010 A EC SP13013010A EC SP13013010 A ECSP13013010 A EC SP13013010A
Authority
EC
Ecuador
Prior art keywords
gadobutrol
high purity
gadovist
magnetic resonance
preparation
Prior art date
Application number
Other languages
English (en)
Inventor
Johannes Platzek
Wilhelm Trentmann
Original Assignee
Bayer Ip Gmbh
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=46208435&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ECSP13013010(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Bayer Ip Gmbh filed Critical Bayer Ip Gmbh
Publication of ECSP13013010A publication Critical patent/ECSP13013010A/es

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • A61K49/06—Nuclear magnetic resonance [NMR] contrast preparations; Magnetic resonance imaging [MRI] contrast preparations
    • A61K49/08—Nuclear magnetic resonance [NMR] contrast preparations; Magnetic resonance imaging [MRI] contrast preparations characterised by the carrier
    • A61K49/10—Organic compounds
    • A61K49/101—Organic compounds the carrier being a complex-forming compound able to form MRI-active complexes with paramagnetic metals
    • A61K49/106—Organic compounds the carrier being a complex-forming compound able to form MRI-active complexes with paramagnetic metals the complex-forming compound being cyclic, e.g. DOTA
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • A61K49/06—Nuclear magnetic resonance [NMR] contrast preparations; Magnetic resonance imaging [MRI] contrast preparations
    • A61K49/08—Nuclear magnetic resonance [NMR] contrast preparations; Magnetic resonance imaging [MRI] contrast preparations characterised by the carrier
    • A61K49/10—Organic compounds
    • A61K49/101—Organic compounds the carrier being a complex-forming compound able to form MRI-active complexes with paramagnetic metals
    • A61K49/106—Organic compounds the carrier being a complex-forming compound able to form MRI-active complexes with paramagnetic metals the complex-forming compound being cyclic, e.g. DOTA
    • A61K49/108—Organic compounds the carrier being a complex-forming compound able to form MRI-active complexes with paramagnetic metals the complex-forming compound being cyclic, e.g. DOTA the metal complex being Gd-DOTA
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D257/00—Heterocyclic compounds containing rings having four nitrogen atoms as the only ring hetero atoms
    • C07D257/02—Heterocyclic compounds containing rings having four nitrogen atoms as the only ring hetero atoms not condensed with other rings
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07F—ACYCLIC, CARBOCYCLIC OR HETEROCYCLIC COMPOUNDS CONTAINING ELEMENTS OTHER THAN CARBON, HYDROGEN, HALOGEN, OXYGEN, NITROGEN, SULFUR, SELENIUM OR TELLURIUM
    • C07F5/00—Compounds containing elements of Groups 3 or 13 of the Periodic Table
    • C07F5/003—Compounds containing elements of Groups 3 or 13 of the Periodic Table without C-Metal linkages
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2123/00—Preparations for testing in vivo

Landscapes

  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Proceso para producir gadobutrol de alta pureza con una pureza (de acuerdo con HPLC) mayor de 99,7 ó 99,8 ó 99,9% y su uso para preparar una formulación farmacéutica para administración parenteral. El proceso se lleva a cabo usando condiciones de cristalización específicamente controladas.Los desarrollos más recientes en el campo de los agentes de contraste de resonancia magnética que contienen gadolinio (EP 0448191 B1, CA Patente 1341176, EP 0643705 B1, EP 0986548 B1, EP 0596586 B1) incluyen el agente de contraste para tomografía de resonancia magnética gadobutrol (Gadovist® 1.0) que ha estado aprobado durante un tiempo relativamente prolongado en Europa y más recientemente también en los EE.UU., con el nombre Gadovist®.
ECSP13013010 2011-04-21 2013-11-05 Preparación de gadobutrol de alta pureza ECSP13013010A (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE102011100128 2011-04-21

Publications (1)

Publication Number Publication Date
ECSP13013010A true ECSP13013010A (es) 2013-12-31

Family

ID=46208435

Family Applications (1)

Application Number Title Priority Date Filing Date
ECSP13013010 ECSP13013010A (es) 2011-04-21 2013-11-05 Preparación de gadobutrol de alta pureza

Country Status (34)

Country Link
US (2) US10072027B2 (es)
EP (2) EP2699556A1 (es)
JP (3) JP6096757B2 (es)
KR (3) KR102003570B1 (es)
CN (1) CN103547573B (es)
AR (1) AR086190A1 (es)
AU (2) AU2012244791B2 (es)
BR (1) BR112013027028B1 (es)
CA (1) CA2833659C (es)
CL (1) CL2013003045A1 (es)
CO (1) CO6801752A2 (es)
CU (2) CU24439B1 (es)
DK (1) DK2896405T3 (es)
DO (1) DOP2013000245A (es)
EA (2) EA201600272A1 (es)
EC (1) ECSP13013010A (es)
ES (1) ES2780599T3 (es)
GT (1) GT201300253A (es)
HR (1) HRP20200336T1 (es)
IL (1) IL228885A (es)
LT (1) LT2896405T (es)
MX (1) MX362133B (es)
MY (1) MY163709A (es)
NZ (1) NZ616637A (es)
PE (1) PE20141325A1 (es)
PH (1) PH12013502168B1 (es)
PL (1) PL2896405T3 (es)
PT (1) PT2896405T (es)
RS (1) RS60001B1 (es)
SG (1) SG194511A1 (es)
SI (1) SI2896405T1 (es)
TW (1) TW201249818A (es)
WO (1) WO2012143355A1 (es)
ZA (1) ZA201308706B (es)

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ES2780599T3 (es) * 2011-04-21 2020-08-26 Bayer Ip Gmbh Preparación de gadobutrol de alta pureza
CN105939994B (zh) * 2014-02-06 2018-05-29 T2医药有限责任公司 纯化1,4,7,10-四氮杂环十二烷-1,4,7,10-四乙酸的方法
KR101693400B1 (ko) * 2014-09-17 2017-01-05 에스티팜 주식회사 칼코부트롤의 제조방법
KR101646211B1 (ko) * 2014-11-12 2016-08-05 (주)디아이테크 자기공명영상용 조영제의 제조방법
KR101653064B1 (ko) * 2014-12-26 2016-09-09 에스티팜 주식회사 가도부트롤의 제조방법
EP3101012A1 (en) 2015-06-04 2016-12-07 Bayer Pharma Aktiengesellschaft New gadolinium chelate compounds for use in magnetic resonance imaging
HUE050553T2 (hu) * 2016-09-27 2020-12-28 Bayer Pharma AG Eljárás A módosulatú kalkobutrol kristályos alakjának elõállítására
CN106543094A (zh) * 2016-11-04 2017-03-29 嘉实（湖南）医药科技有限公司 高纯度钆布醇的制备方法
WO2018096082A1 (en) 2016-11-28 2018-05-31 Bayer Pharma Aktiengesellschaft High relaxivity gadolinium chelate compounds for use in magnetic resonance imaging
GB201703227D0 (en) * 2017-01-20 2017-04-12 Ge Healthcare As Plastic containers
CN109293592A (zh) * 2017-07-24 2019-02-01 天津科伦药物研究有限公司 一种制备钆布醇的方法
KR101971435B1 (ko) 2017-08-29 2019-04-24 주식회사 엔지켐생명과학 가도부트롤 중간체 및 이를 이용한 가도부트롤의 제조 방법
CN108840832A (zh) * 2018-06-29 2018-11-20 广州康瑞泰药业有限公司 一种钆布醇中间体的制备方法
EP3820853A4 (en) * 2018-07-10 2022-08-17 Biophore India Pharmaceuticals Pvt. Ltd. PROCESS FOR THE PREPARATION OF 2,2',2''-(10-((2R,3S)-1,3,4-TRIHYDROXY BUTAN-2-YL)-1,4,7,10-TETRAAZACYCLODODECANE-1 ACID ,4,7-TRIYL) TRIACETIC AND ITS COMPLEXES
KR102167614B1 (ko) * 2018-08-23 2020-10-19 에스티팜 주식회사 가도부트롤의 제조방법
AU2019382881B2 (en) * 2018-11-23 2025-06-12 Bayer Aktiengesellschaft Formulation of contrast media and process of preparation thereof
CA3122681A1 (en) 2018-12-12 2020-06-18 Medibeacon Inc. Uses of transdermal glomerular filtration rate measurement in continuous renal replacement therapy
GB201919073D0 (en) * 2019-12-20 2020-02-05 Ge Healthcare As Novel manufacturing process
CN113087680A (zh) * 2020-01-08 2021-07-09 威智医药有限公司 Dota晶型及其制备方法
CN113105407A (zh) * 2020-01-13 2021-07-13 北京北陆药业股份有限公司 一种钆布醇新型晶型及其制备方法
KR20210114742A (ko) * 2020-03-11 2021-09-24 주식회사 엔지켐생명과학 칼테리돌의 제조방법
CN114539178B (zh) * 2020-11-26 2024-03-15 江苏恒瑞医药股份有限公司 一种钆布醇的纯化方法
CN114573522A (zh) * 2020-11-30 2022-06-03 江苏恒瑞医药股份有限公司 一种考布曲钙的新晶型及其制备方法
EP4284443A4 (en) * 2021-02-01 2025-01-22 Inventure, LLC SYNTHESIS PROCESSES AND COMPOSITIONS WITH LOW INTERMEDIATE AND LOW DICHELATE INTERMEDIATE CONTRAST AGENTS
CN112939806B (zh) * 2021-03-08 2023-05-16 山东新华制药股份有限公司 一种卡比多巴的精制方法
CN113527223B (zh) * 2021-06-22 2023-05-09 安徽普利药业有限公司 一种钆布醇的精制方法
CN114105897B (zh) * 2021-07-29 2023-04-04 安徽普利药业有限公司 一种钆特醇的制备方法
CN116023345A (zh) * 2023-02-16 2023-04-28 渭南瑞联制药有限责任公司 一种钆布醇中间体杂质的制备方法

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ES2780599T3 (es) * 2011-04-21 2020-08-26 Bayer Ip Gmbh Preparación de gadobutrol de alta pureza
KR101653064B1 (ko) 2014-12-26 2016-09-09 에스티팜 주식회사 가도부트롤의 제조방법

Also Published As

Publication number Publication date
AR086190A1 (es) 2013-11-27
ES2780599T3 (es) 2020-08-26
SG194511A1 (en) 2013-12-30
TW201249818A (en) 2012-12-16
JP2014522387A (ja) 2014-09-04
ZA201308706B (en) 2015-08-26
JP2018188477A (ja) 2018-11-29
PT2896405T (pt) 2020-03-31
AU2012244791A1 (en) 2013-10-31
MX2013012290A (es) 2013-11-21
US20140107325A1 (en) 2014-04-17
PL2896405T3 (pl) 2020-06-15
SI2896405T1 (sl) 2020-04-30
EP2896405B1 (en) 2020-02-19
EA201301182A1 (ru) 2014-08-29
EP2896405A1 (en) 2015-07-22
IL228885A0 (en) 2013-12-31
JP2017031220A (ja) 2017-02-09
AU2012244791B2 (en) 2017-04-27
MX362133B (es) 2019-01-07
LT2896405T (lt) 2020-03-25
DOP2013000245A (es) 2013-12-31
US20180105537A1 (en) 2018-04-19
MY163709A (en) 2017-10-13
CL2013003045A1 (es) 2014-05-02
EA201600272A1 (ru) 2016-12-30
RS60001B1 (sr) 2020-04-30
DK2896405T3 (da) 2020-04-06
EP2699556A1 (en) 2014-02-26
KR20140035911A (ko) 2014-03-24
KR20200059319A (ko) 2020-05-28
CU20160163A7 (es) 2017-02-02
HRP20200336T1 (hr) 2020-06-12
WO2012143355A1 (en) 2012-10-26
CA2833659C (en) 2019-12-03
CA2833659A1 (en) 2012-10-26
US10072027B2 (en) 2018-09-11
CN103547573A (zh) 2014-01-29
JP6096757B2 (ja) 2017-03-15
AU2017204495A1 (en) 2017-07-20
CN103547573B (zh) 2016-08-17
KR102003570B1 (ko) 2019-07-24
CU24439B1 (es) 2019-09-04
BR112013027028A2 (pt) 2016-12-27
KR20190079682A (ko) 2019-07-05
NZ616637A (en) 2016-01-29
IL228885A (en) 2016-11-30
PH12013502168B1 (en) 2019-11-27
US10435417B2 (en) 2019-10-08
HK1193817A1 (zh) 2014-10-03
GT201300253A (es) 2015-01-16
CO6801752A2 (es) 2013-11-29
BR112013027028B1 (pt) 2020-08-11
PH12013502168A1 (en) 2014-01-13
CU20130142A7 (es) 2014-02-28
PE20141325A1 (es) 2014-10-08
EA026572B1 (ru) 2017-04-28

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