MX2013012290A - Preparacion de gadobutrol de alta pureza. - Google Patents

Preparacion de gadobutrol de alta pureza.

Info

Publication number
MX2013012290A
MX2013012290A MX2013012290A MX2013012290A MX2013012290A MX 2013012290 A MX2013012290 A MX 2013012290A MX 2013012290 A MX2013012290 A MX 2013012290A MX 2013012290 A MX2013012290 A MX 2013012290A MX 2013012290 A MX2013012290 A MX 2013012290A
Authority
MX
Mexico
Prior art keywords
purity
gadobutrol
preparation
purity gadobutrol
gadovistâ
Prior art date
Application number
MX2013012290A
Other languages
English (en)
Other versions
MX362133B (es
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=MX2013012290(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 MX2013012290A publication Critical patent/MX2013012290A/es
Publication of MX362133B publication Critical patent/MX362133B/es

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

Proceso para producir gadobutrol de alta pureza con una pureza (de acuerdo con HPLC) mayor de 99,7 6 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(r) 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(r).
MX2013012290A 2011-04-21 2012-04-17 Preparacion de gadobutrol de alta pureza. MX362133B (es)

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
MX2013012290A true MX2013012290A (es) 2013-11-21
MX362133B MX362133B (es) 2019-01-07

Family

ID=46208435

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2013012290A MX362133B (es) 2011-04-21 2012-04-17 Preparacion de gadobutrol de alta pureza.

Country Status (34)

Country Link
US (2) US10072027B2 (es)
EP (2) EP2896405B1 (es)
JP (3) JP6096757B2 (es)
KR (3) KR20190079682A (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) EA026572B1 (es)
EC (1) ECSP13013010A (es)
ES (1) ES2780599T3 (es)
GT (1) GT201300253A (es)
HK (1) HK1193817A1 (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)
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)

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
ZA201308706B (en) 2015-08-26
EA201301182A1 (ru) 2014-08-29
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

Similar Documents

Publication Publication Date Title
MX2013012290A (es) Preparacion de gadobutrol de alta pureza.
AU2016219654A1 (en) Crystallization method and bioavailability
IL193951A (en) A compound with central pyrrolidine units, an intermediate compound for the preparation of the mediated compound, a process for the production of the mediated compound, the use of a mediated compound for the manufacture of a drug, a pharmaceutical preparation, a method for the preparation of a pharmaceutical preparation, and a method for making conventional pharmaceutical salt of a non-salts compound.
IL210577A (en) Compound 1,2,3,4-tetrahydrocyclopenta [b] indole-3-yl acetic acid, salt, hydrate and solvent, pharmaceutical, compound, salt, hydrate, solvent or pharmaceutical for use as a medicine or treatment Salt, hydrate, solvent or pharmaceutical preparation in the manufacture of a drug and process for the preparation
WO2012082718A3 (en) 3-methanesulfonylpropionitrile for treating inflammation and pain
MX355836B (es) Composicion que comprende compuestos tetraciclicos.
HK1149258A1 (en) Compounds
PL2018379T3 (pl) Sole skopiny oraz ich zastosowanie w sposobach wytwarzania N-demetylo-tiotropium i bromku tiotropium
WO2009125434A3 (en) Oxime derivatives, process for their preparation, pharmaceutical composition containing the same and medicinal use thereof
HK1197414A1 (zh) 雌甾- -四烯- -甲酰胺衍生物、其製備方法、包含其的藥物製劑及其用於製備藥物的用途
MX2013000474A (es) Derivados de arilamida novedosos que tienen propiedades antiandrogenicas.
WO2010070677A3 (en) A process for the preparation of prasugrel and its pharmaceutically acceptable salts thereof
WO2011009714A3 (en) Benzoquinolizinium salt derivatives as anticancer agents
WO2011081373A3 (en) Method for preparing highly pure anhydrous crystalline docetaxel
WO2010046932A3 (en) Extended release pharmaceutical composition of minocycline and process thereof
PL2291374T3 (pl) Sposób wytwarzania solifenacyny i/lub jej farmaceutycznie dopuszczalnych soli o wysokiej czystości farmaceutycznej
WO2010089259A3 (en) Sustained release composition containing quetiapine
WO2011031099A3 (en) Ursodeoxycholic acid-synthetic hydrotalcite-eudragit hybrid, pharmaceutical composition containing the same and method for preparing the same
WO2010068181A8 (en) 11-(2-pyrrolidin-1-yl-ethoxy)-14,19-dioxa-5,7,26-triaza-tetracyclo[19.3.1.1(2,6)1(8,12)]heptacosa-1(25),2(26),3,5,8,10,12(27),16,21,23-decaene citrate salt
WO2011095801A3 (en) Liquid pharmaceutical composition for buccal administration comprising morphine
WO2011061609A3 (en) Processes for the preparation of cilastatin
WO2009121946A3 (en) Process for the preparation of optically enriched clopidogrel
WO2011149206A3 (en) Pharmaceutical composition containing crystalline nebivolol hydrochloride and method for preparing the same
WO2012131412A3 (en) Pharmaceutical composition containing no, process for the preparation and use thereof
EP2617702A4 (en) NOVEL BIPHENYL COMPOUND OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PROCESS FOR THE PREPARATION OF THE NEW BIPHENYL COMPOUND OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND PHARMACEUTICAL COMPOSITION CONTAINING THE SAME AS ACTIVE INGREDIENT FOR PREVENTING OR TREATING COMPLICATIONS OF DIABETES

Legal Events

Date Code Title Description
FG Grant or registration