EA201301182A1 - Получение гадобутрола высокой чистоты - Google Patents

Получение гадобутрола высокой чистоты

Info

Publication number
EA201301182A1
EA201301182A1 EA201301182A EA201301182A EA201301182A1 EA 201301182 A1 EA201301182 A1 EA 201301182A1 EA 201301182 A EA201301182 A EA 201301182A EA 201301182 A EA201301182 A EA 201301182A EA 201301182 A1 EA201301182 A1 EA 201301182A1
Authority
EA
Eurasian Patent Office
Prior art keywords
hadobutrol
getting
purity
high purity
gadobutrol
Prior art date
Application number
EA201301182A
Other languages
English (en)
Other versions
EA026572B1 (ru
Inventor
Иоганнес Платцек
Вильхельм Трентманн
Original Assignee
Байер Интеллектчуал Проперти Гмбх
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=EA201301182(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Байер Интеллектчуал Проперти Гмбх filed Critical Байер Интеллектчуал Проперти Гмбх
Publication of EA201301182A1 publication Critical patent/EA201301182A1/ru
Publication of EA026572B1 publication Critical patent/EA026572B1/ru

Links

Classifications

    • 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 System
    • C07F5/003—Compounds containing elements of Groups 3 or 13 of the Periodic System without C-Metal linkages
    • 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
    • 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

Описан способ получения гадобутрола высокой чистоты с чистотой (согласно ВЭЖХ) более чем 99.7, или 99.8, или 99.9% и применение для получения фармацевтического препарата для парентерального введения. Способ осуществляли, применяя определенно контролируемые условия кристаллизации. Самые последние достижения в области гадолинийсодержащих МР контрастных агентов (ЕР 0448191 В1, патент СА 1341176, ЕР 0643705 В1, ЕР 0986548 В1, ЕР 0596586 В1) включают МРТ контрастный агент гадобутрол (Gadovist® 1.0), который одобрялся в течение долгого времени в Европе и позже также в США под названием Gadavist®.
EA201301182A 2011-04-21 2012-04-17 Получение гадобутрола высокой чистоты EA026572B1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102011100128 2011-04-21
PCT/EP2012/057013 WO2012143355A1 (en) 2011-04-21 2012-04-17 Preparation of high-purity gadobutrol

Publications (2)

Publication Number Publication Date
EA201301182A1 true EA201301182A1 (ru) 2014-08-29
EA026572B1 EA026572B1 (ru) 2017-04-28

Family

ID=46208435

Family Applications (2)

Application Number Title Priority Date Filing Date
EA201301182A EA026572B1 (ru) 2011-04-21 2012-04-17 Получение гадобутрола высокой чистоты
EA201600272A EA201600272A1 (ru) 2011-04-21 2012-04-17 Получение гадобутрола высокой чистоты

Family Applications After (1)

Application Number Title Priority Date Filing Date
EA201600272A EA201600272A1 (ru) 2011-04-21 2012-04-17 Получение гадобутрола высокой чистоты

Country Status (34)

Country Link
US (2) US10072027B2 (ru)
EP (2) EP2896405B1 (ru)
JP (3) JP6096757B2 (ru)
KR (3) KR20190079682A (ru)
CN (1) CN103547573B (ru)
AR (1) AR086190A1 (ru)
AU (2) AU2012244791B2 (ru)
BR (1) BR112013027028B1 (ru)
CA (1) CA2833659C (ru)
CL (1) CL2013003045A1 (ru)
CO (1) CO6801752A2 (ru)
CU (2) CU24439B1 (ru)
DK (1) DK2896405T3 (ru)
DO (1) DOP2013000245A (ru)
EA (2) EA026572B1 (ru)
EC (1) ECSP13013010A (ru)
ES (1) ES2780599T3 (ru)
GT (1) GT201300253A (ru)
HK (1) HK1193817A1 (ru)
HR (1) HRP20200336T1 (ru)
IL (1) IL228885A (ru)
LT (1) LT2896405T (ru)
MX (1) MX362133B (ru)
MY (1) MY163709A (ru)
NZ (1) NZ616637A (ru)
PE (1) PE20141325A1 (ru)
PL (1) PL2896405T3 (ru)
PT (1) PT2896405T (ru)
RS (1) RS60001B1 (ru)
SG (1) SG194511A1 (ru)
SI (1) SI2896405T1 (ru)
TW (1) TW201249818A (ru)
WO (1) WO2012143355A1 (ru)
ZA (1) ZA201308706B (ru)

Families Citing this family (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RS60001B1 (sr) * 2011-04-21 2020-04-30 Bayer Ip Gmbh Pripremanje gadobutrola visoke čistoće
US10195295B2 (en) * 2014-02-06 2019-02-05 T2Pharma Gmbh Process for purifying 1,4,7,10-tetra-azacyclododecane-1,4,7,10-tetraacetic acid
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
PL3519394T3 (pl) 2016-09-27 2020-11-30 Bayer Pharma Aktiengesellschaft Sposób wytwarzania krystalicznej postaci o modyfikacji a kalkobutrolu
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
EP3544964B1 (en) 2016-11-28 2020-06-17 Bayer Pharma Aktiengesellschaft High relaxivity gadolinium chelate compounds for use in magnetic resonance imaging
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-TETRAAZACYCLODODECAN-1,4 ,7-TRIYL)-TRIACETIC ACID AND THEIR COMPLEXES
KR102167614B1 (ko) * 2018-08-23 2020-10-19 에스티팜 주식회사 가도부트롤의 제조방법
AU2019382881A1 (en) 2018-11-23 2021-05-20 Bayer Aktiengesellschaft Formulation of contrast media and process of preparation thereof
JP2022513195A (ja) * 2018-12-12 2022-02-07 メディビーコン，インク． 持続的腎代替療法における経皮的糸球体濾過量測定の使用
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
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

Family Cites Families (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4957939A (en) 1981-07-24 1990-09-18 Schering Aktiengesellschaft Sterile pharmaceutical compositions of gadolinium chelates useful enhancing NMR imaging
NL194579C (nl) 1983-01-21 2002-08-05 Schering Ag Diagnostisch middel.
US4885363A (en) 1987-04-24 1989-12-05 E. R. Squibb & Sons, Inc. 1-substituted-1,4,7-triscarboxymethyl-1,4,7,10-tetraazacyclododecane and analogs
DE3625417C2 (de) 1986-07-28 1998-10-08 Schering Ag Tetraazacyclododecan-Derivate
DE3640708C2 (de) 1986-11-28 1995-05-18 Schering Ag Verbesserte metallhaltige Pharmazeutika
DE4009119A1 (de) 1990-03-19 1991-09-26 Schering Ag 1,4,7,10-tetraazacyclododecan-butyltriole, verfahren zu ihrer herstellung und diese enthaltende pharmazeutische mittel
US7385041B2 (en) 1990-04-25 2008-06-10 Bracco International B.V. Dual functioning excipient for metal chelate contrast agents
DE4035760A1 (de) 1990-11-08 1992-05-14 Schering Ag Mono-n-substituierte 1,4,7,10-tetraazacyclododecan-derivate, verfahren zu ihrer herstellung und diese enthaltende pharmazeutische mittel
US5410043A (en) 1991-12-06 1995-04-25 Schering Aktiengesellschaft Process for the production of mono-N-substituted tetraaza macrocycles
DE4237943C2 (de) 1992-11-06 1997-10-23 Schering Ag Verfahren zur Herstellung von Metallkomplexen der N-beta-Hydroxyalkyl-tri-N-carboxyalkyl-1,4,7,10-tetraazacyclododecan- und N-beta-Hydroxyalkyl-tri-N-carboxyalkyl-1,4,8,11-tetraazacyclotetradecan-Derivate
DE4140779A1 (de) 1991-12-06 1993-06-09 Schering Ag Berlin Und Bergkamen, 1000 Berlin, De Verfahren zur herstellung von mono-n-substituierten tetraazamakrocyclen
DE4218744C2 (de) 1992-06-04 1997-11-06 Schering Ag Verfahren zur Herstellung von N-ß-Hxdroxyalkyl-tri-N-carboxylalkyl-1,4,7,10-tetraazacyclododecan- und N-ß-Hydroxyalkyl-tri-N-carboxyalkyl-1,4,8,11-tetraazacyclotetradecan-Derivaten und deren Metallkomplexe
IT1275426B (it) 1995-05-16 1997-08-07 Bracco Spa Recupero del gadolinio e dei suoi agenti complessanti da soluzioni acquose contenenti i loro complessi
US5744616A (en) 1996-02-26 1998-04-28 Schering Aktiengesellschaft Process for the production of 1,4,7,10-tetraazacyclododecane and its derivatives
DE19608307C1 (de) * 1996-02-26 1997-08-28 Schering Ag Verfahren zur Herstellung von 1,4,7,10-Tetraazacyclododecan und dessen Derivaten
DE19724186C2 (de) 1997-06-02 2002-07-18 Schering Ag Verfahren zur Mono- und 1,7-Bis-N-ß-Hydroxyalkylierung von Cyclen und die entsprechenden N-ß-Hydroxyalkyl-1,4,7,10-tetraazacyclododecan-Li-Salz-Komplexe
IT1292127B1 (it) 1997-06-11 1999-01-25 Bracco Spa Processo per la dissalazione di sostanze instabili a ph acidi
IT1292128B1 (it) * 1997-06-11 1999-01-25 Bracco Spa Processo per la preparazione di chelanti macrociclici e loro chelati con ioni metallici paramagnetici
DE69903603T2 (de) 1998-09-08 2003-08-14 Kba Giori Sa Sicherheitsdruckmaschine für Wertpapiere
DE10064467C2 (de) * 2000-12-15 2002-10-31 Schering Ag Lithium-Komplexe von N-(1-Hydroxymethyl-2,3-dihydroxypropyl)-1,4,7-triscarboxymethyl-1,4,7,10-tetraazacyclododecan, deren Herstellung und Verwendung
DE102009053171B4 (de) 2009-11-04 2011-07-21 Bayer Schering Pharma Aktiengesellschaft, 13353 Verfahren zur Herstellung des Calcium-Komplexes von Dihydroxy-hydroxy-methylpropyl-tetraazacyclododecan-triessigsäure (Calcobutrol)
WO2011054480A1 (de) 2009-11-09 2011-05-12 Bayer Schering Pharma Aktiengesellschaft Gadobutrolherstellung mittels keramischer membran
DE102010013833A1 (de) 2010-03-29 2011-09-29 Bayer Schering Pharma Aktiengesellschaft Herstellung von Gadobutrol mittels Dimethylformamiddimethylacetal
DE102010023105A1 (de) 2010-06-04 2011-12-08 Bayer Schering Pharma Aktiengesellschaft Gadobutrolherstellung im Eintopfverfahren mittels DMF-acetal und N-Methylimidazol
RS60001B1 (sr) * 2011-04-21 2020-04-30 Bayer Ip Gmbh Pripremanje gadobutrola visoke čistoće
KR101653064B1 (ko) 2014-12-26 2016-09-09 에스티팜 주식회사 가도부트롤의 제조방법

Also Published As

Publication number Publication date
KR102003570B1 (ko) 2019-07-24
KR20200059319A (ko) 2020-05-28
EP2896405A1 (en) 2015-07-22
US20140107325A1 (en) 2014-04-17
MX2013012290A (es) 2013-11-21
ZA201308706B (en) 2015-08-26
PE20141325A1 (es) 2014-10-08
WO2012143355A1 (en) 2012-10-26
PL2896405T3 (pl) 2020-06-15
AR086190A1 (es) 2013-11-27
RS60001B1 (sr) 2020-04-30
IL228885A0 (en) 2013-12-31
AU2017204495A1 (en) 2017-07-20
CN103547573A (zh) 2014-01-29
MY163709A (en) 2017-10-13
CL2013003045A1 (es) 2014-05-02
AU2012244791B2 (en) 2017-04-27
JP2018188477A (ja) 2018-11-29
TW201249818A (en) 2012-12-16
US10072027B2 (en) 2018-09-11
DK2896405T3 (da) 2020-04-06
KR20140035911A (ko) 2014-03-24
EP2896405B1 (en) 2020-02-19
EA026572B1 (ru) 2017-04-28
CU20130142A7 (es) 2014-02-28
AU2012244791A1 (en) 2013-10-31
CN103547573B (zh) 2016-08-17
CA2833659C (en) 2019-12-03
JP2014522387A (ja) 2014-09-04
KR20190079682A (ko) 2019-07-05
NZ616637A (en) 2016-01-29
PT2896405T (pt) 2020-03-31
EA201600272A1 (ru) 2016-12-30
CO6801752A2 (es) 2013-11-29
GT201300253A (es) 2015-01-16
IL228885A (en) 2016-11-30
CU24439B1 (es) 2019-09-04
JP2017031220A (ja) 2017-02-09
ES2780599T3 (es) 2020-08-26
LT2896405T (lt) 2020-03-25
SI2896405T1 (sl) 2020-04-30
BR112013027028A2 (pt) 2016-12-27
HRP20200336T1 (hr) 2020-06-12
EP2699556A1 (en) 2014-02-26
CU20160163A7 (es) 2017-02-02
MX362133B (es) 2019-01-07
US20180105537A1 (en) 2018-04-19
DOP2013000245A (es) 2013-12-31
HK1193817A1 (zh) 2014-10-03
CA2833659A1 (en) 2012-10-26
US10435417B2 (en) 2019-10-08
ECSP13013010A (es) 2013-12-31
SG194511A1 (en) 2013-12-30
BR112013027028B1 (pt) 2020-08-11
JP6096757B2 (ja) 2017-03-15

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