BR112013027028A2 - preparo de gadobutrol de alta pureza - Google Patents

preparo de gadobutrol de alta pureza

Info

Publication number
BR112013027028A2
BR112013027028A2 BR112013027028A BR112013027028A BR112013027028A2 BR 112013027028 A2 BR112013027028 A2 BR 112013027028A2 BR 112013027028 A BR112013027028 A BR 112013027028A BR 112013027028 A BR112013027028 A BR 112013027028A BR 112013027028 A2 BR112013027028 A2 BR 112013027028A2
Authority
BR
Brazil
Prior art keywords
preparation
gadobutrol
high purity
purity gadobutrol
purity
Prior art date
Application number
BR112013027028A
Other languages
English (en)
Other versions
BR112013027028B1 (pt
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=BR112013027028(A2) "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 BR112013027028A2 publication Critical patent/BR112013027028A2/pt
Publication of BR112013027028B1 publication Critical patent/BR112013027028B1/pt

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

resumo patente de invenção: "preparo de gadobutrol de alta pureza". a presente invenção refere-se a um processo para produzir o gadobutrol de alta pureza em uma pureza (de acordo com hplc) maior do que 99,7 ou 99,8 ou 99,9% e o uso para o preparo de uma formulação farmacêutica para a administração parenteral. o processo é executado usando condições de cristalização especificamente controladas. os desenvolvimentos mais recentes no campo dos agentes de contraste mr contendo gadolínio (ep 0448191 b1, patente ca 1341176, ep 0643705 b1, ep 0986548 b1, ep 0596586 b1) incluem o agente de contraste mrt gadobutrol (gadovist(r) 1.0) que foi aprovado há um tempo relativamente longo na europa e mais recentemente também nos eua sob o nome gadavist(r).
BR112013027028-4A 2011-04-21 2012-04-17 Processo para produção de gadobutrol com elevada pureza BR112013027028B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE102011100128.3 2011-04-21
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
BR112013027028A2 true BR112013027028A2 (pt) 2016-12-27
BR112013027028B1 BR112013027028B1 (pt) 2020-08-11

Family

ID=46208435

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112013027028-4A BR112013027028B1 (pt) 2011-04-21 2012-04-17 Processo para produção de gadobutrol com elevada pureza

Country Status (34)

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

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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

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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
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
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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B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
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B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
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Owner name: BAYER INTELLECTUAL PROPERTY GMBH (DE)