ECSP13013010A - Preparación de gadobutrol de alta pureza - Google Patents
Preparación de gadobutrol de alta purezaInfo
- 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
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 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
- A61K2123/00—Preparations for testing in vivo
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®.
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) | 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)
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)
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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 |
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2012
- 2012-04-17 RS RS20200238A patent/RS60001B1/sr unknown
- 2012-04-17 PE PE2013002379A patent/PE20141325A1/es active IP Right Grant
- 2012-04-17 EP EP14172784.2A patent/EP2896405B1/en active Active
- 2012-04-17 KR KR1020197017528A patent/KR20190079682A/ko active Application Filing
- 2012-04-17 BR BR112013027028-4A patent/BR112013027028B1/pt active IP Right Grant
- 2012-04-17 EA EA201301182A patent/EA026572B1/ru not_active IP Right Cessation
- 2012-04-17 US US14/112,994 patent/US10072027B2/en active Active
- 2012-04-17 EA EA201600272A patent/EA201600272A1/ru unknown
- 2012-04-17 MX MX2013012290A patent/MX362133B/es active IP Right Grant
- 2012-04-17 CA CA2833659A patent/CA2833659C/en active Active
- 2012-04-17 EP EP12725635.2A patent/EP2699556A1/en not_active Ceased
- 2012-04-17 LT LTEP14172784.2T patent/LT2896405T/lt unknown
- 2012-04-17 CN CN201280024781.7A patent/CN103547573B/zh active Active
- 2012-04-17 DK DK14172784.2T patent/DK2896405T3/da active
- 2012-04-17 KR KR1020207014352A patent/KR20200059319A/ko not_active IP Right Cessation
- 2012-04-17 PT PT141727842T patent/PT2896405T/pt unknown
- 2012-04-17 AU AU2012244791A patent/AU2012244791B2/en active Active
- 2012-04-17 SG SG2013077094A patent/SG194511A1/en unknown
- 2012-04-17 KR KR1020137030655A patent/KR102003570B1/ko active IP Right Grant
- 2012-04-17 NZ NZ616637A patent/NZ616637A/en unknown
- 2012-04-17 SI SI201231741T patent/SI2896405T1/sl unknown
- 2012-04-17 WO PCT/EP2012/057013 patent/WO2012143355A1/en active Application Filing
- 2012-04-17 MY MYPI2013701962A patent/MY163709A/en unknown
- 2012-04-17 PL PL14172784T patent/PL2896405T3/pl unknown
- 2012-04-17 JP JP2014505591A patent/JP6096757B2/ja active Active
- 2012-04-17 ES ES14172784T patent/ES2780599T3/es active Active
- 2012-04-17 CU CU2016000163A patent/CU24439B1/es unknown
- 2012-04-20 AR ARP120101354A patent/AR086190A1/es active Pending
- 2012-04-23 TW TW101114466A patent/TW201249818A/zh unknown
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2013
- 2013-10-15 IL IL228885A patent/IL228885A/en active IP Right Grant
- 2013-10-18 GT GT201300253A patent/GT201300253A/es unknown
- 2013-10-21 CO CO13248770A patent/CO6801752A2/es not_active Application Discontinuation
- 2013-10-21 CU CU2013000142A patent/CU20130142A7/es unknown
- 2013-10-21 DO DO2013000245A patent/DOP2013000245A/es unknown
- 2013-10-21 CL CL2013003045A patent/CL2013003045A1/es unknown
- 2013-11-05 EC ECSP13013010 patent/ECSP13013010A/es unknown
- 2013-11-20 ZA ZA2013/08706A patent/ZA201308706B/en unknown
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2014
- 2014-07-15 HK HK14107203.2A patent/HK1193817A1/zh unknown
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2016
- 2016-11-08 JP JP2016217880A patent/JP2017031220A/ja active Pending
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2017
- 2017-06-30 AU AU2017204495A patent/AU2017204495A1/en not_active Abandoned
- 2017-07-31 US US15/664,060 patent/US10435417B2/en active Active
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2018
- 2018-09-05 JP JP2018165787A patent/JP2018188477A/ja active Pending
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2020
- 2020-02-27 HR HRP20200336TT patent/HRP20200336T1/hr unknown
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