BR112012012358A2 - processo para preparação de complexo de gadobenato de dimeglumina em uma forma sólida - Google Patents

processo para preparação de complexo de gadobenato de dimeglumina em uma forma sólida

Info

Publication number
BR112012012358A2
BR112012012358A2 BR112012012358A BR112012012358A BR112012012358A2 BR 112012012358 A2 BR112012012358 A2 BR 112012012358A2 BR 112012012358 A BR112012012358 A BR 112012012358A BR 112012012358 A BR112012012358 A BR 112012012358A BR 112012012358 A2 BR112012012358 A2 BR 112012012358A2
Authority
BR
Brazil
Prior art keywords
solid form
preparation
complex
dimeglumine gadobenate
dimeglumine
Prior art date
Application number
BR112012012358A
Other languages
English (en)
Other versions
BR112012012358B8 (pt
BR112012012358B1 (pt
BR112012012358A8 (pt
Inventor
Aurelia Ferrigato
Fulvio Uggeri
Luciano Lattuada
Pier Francesco Morosini
Pier Lucio Anelli
Roberta Fretta
Silvia Ceragioli
Original Assignee
Bracco Imaging Spa
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
Application filed by Bracco Imaging Spa filed Critical Bracco Imaging Spa
Publication of BR112012012358A2 publication Critical patent/BR112012012358A2/pt
Publication of BR112012012358A8 publication Critical patent/BR112012012358A8/pt
Publication of BR112012012358B1 publication Critical patent/BR112012012358B1/pt
Publication of BR112012012358B8 publication Critical patent/BR112012012358B8/pt

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00Preparations for testing in vivo
    • A61K49/06Nuclear magnetic resonance [NMR] contrast preparations; Magnetic resonance imaging [MRI] contrast preparations
    • A61K49/18Nuclear magnetic resonance [NMR] contrast preparations; Magnetic resonance imaging [MRI] contrast preparations characterised by a special physical form, e.g. emulsions, microcapsules, liposomes
    • A61K49/1818Nuclear magnetic resonance [NMR] contrast preparations; Magnetic resonance imaging [MRI] contrast preparations characterised by a special physical form, e.g. emulsions, microcapsules, liposomes particles, e.g. uncoated or non-functionalised microparticles or nanoparticles
    • A61K49/1887Agglomerates, clusters, i.e. more than one (super)(para)magnetic microparticle or nanoparticle are aggregated or entrapped in the same maxtrix
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C227/00Preparation of compounds containing amino and carboxyl groups bound to the same carbon skeleton
    • C07C227/38Separation; Purification; Stabilisation; Use of additives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00Preparations for testing in vivo
    • A61K49/06Nuclear magnetic resonance [NMR] contrast preparations; Magnetic resonance imaging [MRI] contrast preparations
    • A61K49/08Nuclear magnetic resonance [NMR] contrast preparations; Magnetic resonance imaging [MRI] contrast preparations characterised by the carrier
    • A61K49/10Organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C67/00Shaping techniques not covered by groups B29C39/00 - B29C65/00, B29C70/00 or B29C73/00
    • B29C67/24Shaping techniques not covered by groups B29C39/00 - B29C65/00, B29C70/00 or B29C73/00 characterised by the choice of material
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C213/00Preparation of compounds containing amino and hydroxy, amino and etherified hydroxy or amino and esterified hydroxy groups bound to the same carbon skeleton
    • C07C213/10Separation; Purification; Stabilisation; Use of additives
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C227/00Preparation of compounds containing amino and carboxyl groups bound to the same carbon skeleton
    • C07C227/38Separation; Purification; Stabilisation; Use of additives
    • C07C227/40Separation; Purification
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00Stock material or miscellaneous articles
    • Y10T428/29Coated or structually defined flake, particle, cell, strand, strand portion, rod, filament, macroscopic fiber or mass thereof
    • Y10T428/2982Particulate matter [e.g., sphere, flake, etc.]

Landscapes

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

Abstract

processo para preparação de complexo de gadobenato de dimeglumina em uma forma sólida a presente invenção descreve um rpocesso para a preparação do complexo gadobenato de dimeglumina em forma sólida. em particular, a referida forma sólida é convenientemente obtida pela secagem por pulverização de uma suspensão líquida correspondente a uma dada temperatura e concentração. a presente invenção é particularmente vantajosa para a escala industrial como a forma sólida pode ser obtida por água empregando como solvente, que é um solvente não-tóxico, fácil de manusear e, basicamente, não necessitando preocupações com a saúde ou precauções de segurança.
BR112012012358A 2009-11-23 2010-11-23 processo para a preparação de complexo de dimeglumina de gadobenato em uma forma sólida, forma sólida em pó de dimeglumina de gadobenato e kit farmacêutico BR112012012358B8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP09176713.7 2009-11-23
EP09176713A EP2327395A1 (en) 2009-11-23 2009-11-23 Process for the preparation of gadobenate dimeglumine complex in a solid form
PCT/EP2010/067981 WO2011061341A1 (en) 2009-11-23 2010-11-23 Process for the preparation of gadobenate dimeglumine complex in a solid form

Publications (4)

Publication Number Publication Date
BR112012012358A2 true BR112012012358A2 (pt) 2016-03-22
BR112012012358A8 BR112012012358A8 (pt) 2018-06-05
BR112012012358B1 BR112012012358B1 (pt) 2020-12-08
BR112012012358B8 BR112012012358B8 (pt) 2021-07-27

Family

ID=42077873

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112012012358A BR112012012358B8 (pt) 2009-11-23 2010-11-23 processo para a preparação de complexo de dimeglumina de gadobenato em uma forma sólida, forma sólida em pó de dimeglumina de gadobenato e kit farmacêutico

Country Status (21)

Country Link
US (2) US20120232151A1 (pt)
EP (2) EP2327395A1 (pt)
JP (1) JP5607746B2 (pt)
KR (2) KR101624504B1 (pt)
CN (3) CN106986784A (pt)
AU (1) AU2010320832B2 (pt)
BR (1) BR112012012358B8 (pt)
CA (1) CA2781718C (pt)
CY (1) CY1114342T1 (pt)
DK (1) DK2503990T3 (pt)
ES (1) ES2426271T3 (pt)
HR (1) HRP20130773T1 (pt)
IL (1) IL219928A (pt)
MX (1) MX2012005939A (pt)
NZ (1) NZ600334A (pt)
PL (1) PL2503990T3 (pt)
PT (1) PT2503990E (pt)
RS (1) RS52915B (pt)
RU (1) RU2539576C2 (pt)
SI (1) SI2503990T1 (pt)
WO (1) WO2011061341A1 (pt)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2977369A1 (en) * 2014-07-24 2016-01-27 Bracco Imaging SPA Preparation of a solid form of gadobenate dimeglumine
CN106053642A (zh) * 2016-05-27 2016-10-26 扬子江药业集团广州海瑞药业有限公司 一种钆贝葡胺的含量检测控制方法
CN111375070A (zh) * 2018-12-26 2020-07-07 江苏恒瑞医药股份有限公司 一种制备造影剂的方法

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT1213029B (it) 1986-01-30 1989-12-07 Bracco Ind Chimica Spa Chelati di ioni metallici paramagnetici.
AU620841B2 (en) 1987-12-24 1992-02-27 Bracco International B.V. Macrocyclic chelating agents and chelates thereof
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
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
JPH06181890A (ja) * 1992-10-06 1994-07-05 Terumo Corp Mri造影剤
JPH10509424A (ja) * 1994-10-03 1998-09-14 ザ トラスティーズ オブ ザ ユニバーシティー オブ ペンシルバニア 磁気共鳴イメージングで顕著な効果を示すキレート錯体
DE19958586A1 (de) * 1999-12-06 2001-06-07 Aventis Res & Tech Gmbh & Co Mikropartikel auf Basis von Asparaginsäure und deren Verwendung als MRI-Kontrastmittel
GB0123013D0 (en) * 2001-09-25 2001-11-14 Upperton Ltd Improvements relating to imaging contrast agents
EP1762563A1 (en) * 2005-09-13 2007-03-14 BRACCO IMAGING S.p.A. Process for the preparation of contrast agents
US8192721B2 (en) * 2007-12-13 2012-06-05 Verrow Pharmaceuticals, Inc. Compositions useful for reducing toxicity associated with gadolinium-based contrast agents

Also Published As

Publication number Publication date
CA2781718A1 (en) 2011-05-26
IL219928A0 (en) 2012-07-31
US20160228583A1 (en) 2016-08-11
US9795695B2 (en) 2017-10-24
CY1114342T1 (el) 2016-08-31
BR112012012358B8 (pt) 2021-07-27
JP5607746B2 (ja) 2014-10-15
KR101624504B1 (ko) 2016-05-26
IL219928A (en) 2016-03-31
RU2012125964A (ru) 2013-12-27
DK2503990T3 (da) 2013-09-02
CN113105346A (zh) 2021-07-13
SI2503990T1 (sl) 2013-09-30
AU2010320832A1 (en) 2012-06-21
RS52915B (en) 2014-02-28
AU2010320832B2 (en) 2014-08-21
MX2012005939A (es) 2012-06-25
NZ600334A (en) 2014-10-31
KR20160043137A (ko) 2016-04-20
BR112012012358B1 (pt) 2020-12-08
RU2539576C2 (ru) 2015-01-20
EP2503990A1 (en) 2012-10-03
HRP20130773T1 (hr) 2013-11-08
CA2781718C (en) 2015-02-03
EP2503990B1 (en) 2013-06-05
CN106986784A (zh) 2017-07-28
EP2327395A1 (en) 2011-06-01
JP2013511497A (ja) 2013-04-04
CN102724964A (zh) 2012-10-10
ES2426271T3 (es) 2013-10-22
KR20120101462A (ko) 2012-09-13
PL2503990T3 (pl) 2013-11-29
PT2503990E (pt) 2013-09-03
WO2011061341A1 (en) 2011-05-26
BR112012012358A8 (pt) 2018-06-05
US20120232151A1 (en) 2012-09-13

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Legal Events

Date Code Title Description
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B07G Grant request does not fulfill article 229-c lpi (prior consent of anvisa) [chapter 7.7 patent gazette]
B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 08/12/2020, OBSERVADAS AS CONDICOES LEGAIS.

B16C Correction of notification of the grant [chapter 16.3 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 23/11/2010, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO