BR112012012358B8 - 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 - Google Patents

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

Info

Publication number
BR112012012358B8
BR112012012358B8 BR112012012358A BR112012012358A BR112012012358B8 BR 112012012358 B8 BR112012012358 B8 BR 112012012358B8 BR 112012012358 A BR112012012358 A BR 112012012358A BR 112012012358 A BR112012012358 A BR 112012012358A BR 112012012358 B8 BR112012012358 B8 BR 112012012358B8
Authority
BR
Brazil
Prior art keywords
solid form
gadobenate dimeglumine
preparing
complex
pharmaceutical kit
Prior art date
Application number
BR112012012358A
Other languages
English (en)
Other versions
BR112012012358A2 (pt
BR112012012358A8 (pt
BR112012012358B1 (pt
Inventor
Ferrigato Aurelia
Uggeri Fulvio
Lattuada Luciano
Francesco Morosini Pier
Lucio Anelli Pier
Fretta Roberta
Ceragioli Silvia
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

    • 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
    • A61K49/18—Nuclear magnetic resonance [NMR] contrast preparations; Magnetic resonance imaging [MRI] contrast preparations characterised by a special physical form, e.g. emulsions, microcapsules, liposomes
    • A61K49/1818—Nuclear 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
    • A61K49/1887—Agglomerates, clusters, i.e. more than one (super)(para)magnetic microparticle or nanoparticle are aggregated or entrapped in the same maxtrix
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C67/00—Shaping techniques not covered by groups B29C39/00 - B29C65/00, B29C70/00 or B29C73/00
    • B29C67/24—Shaping techniques not covered by groups B29C39/00 - B29C65/00, B29C70/00 or B29C73/00 characterised by the choice of material
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C213/00—Preparation of compounds containing amino and hydroxy, amino and etherified hydroxy or amino and esterified hydroxy groups bound to the same carbon skeleton
    • C07C213/10—Separation; Purification; Stabilisation; Use of additives
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C227/00—Preparation of compounds containing amino and carboxyl groups bound to the same carbon skeleton
    • C07C227/38—Separation; Purification; Stabilisation; Use of additives
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C227/00—Preparation of compounds containing amino and carboxyl groups bound to the same carbon skeleton
    • C07C227/38—Separation; Purification; Stabilisation; Use of additives
    • C07C227/40—Separation; Purification
    • Y—GENERAL 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
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/29—Coated or structually defined flake, particle, cell, strand, strand portion, rod, filament, macroscopic fiber or mass thereof
    • Y10T428/2982—Particulate 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 dimeglumina de gadobenato em uma forma sólida a presente invenção descreve um processo para a preparação do complexo de dimeglumina de gadobenato em uma 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 uma vez que a forma sólida pode ser obtida empregando água com um solvente, que é um solvente não tóxico, fácil de manipular, e basicamente não requer precauções problemáticos de saúde ou 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 BR112012012358A2 (pt) 2016-03-22
BR112012012358A8 BR112012012358A8 (pt) 2018-06-05
BR112012012358B1 BR112012012358B1 (pt) 2020-12-08
BR112012012358B8 true 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) CN113105346A (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.
DE440606T1 (de) 1987-12-24 1992-02-27 Bracco Industria Chimica S.P.A., Mailand / Milano, It Macrocyclische chelatisierungsmittel und daraus hergestellte chelate.
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
AU3946395A (en) * 1994-10-03 1996-04-26 Trustees Of The University Of Pennsylvania, The Chelate complex with high conspicuity for magnetic resonance imaging
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
ES2426271T3 (es) 2013-10-22
PL2503990T3 (pl) 2013-11-29
CY1114342T1 (el) 2016-08-31
US9795695B2 (en) 2017-10-24
SI2503990T1 (sl) 2013-09-30
KR101624504B1 (ko) 2016-05-26
RU2539576C2 (ru) 2015-01-20
RS52915B (en) 2014-02-28
HRP20130773T1 (hr) 2013-11-08
CN106986784A (zh) 2017-07-28
EP2327395A1 (en) 2011-06-01
IL219928A0 (en) 2012-07-31
AU2010320832A1 (en) 2012-06-21
BR112012012358A2 (pt) 2016-03-22
JP5607746B2 (ja) 2014-10-15
RU2012125964A (ru) 2013-12-27
KR20120101462A (ko) 2012-09-13
DK2503990T3 (da) 2013-09-02
BR112012012358A8 (pt) 2018-06-05
CA2781718C (en) 2015-02-03
EP2503990A1 (en) 2012-10-03
US20120232151A1 (en) 2012-09-13
EP2503990B1 (en) 2013-06-05
AU2010320832B2 (en) 2014-08-21
WO2011061341A1 (en) 2011-05-26
KR20160043137A (ko) 2016-04-20
JP2013511497A (ja) 2013-04-04
US20160228583A1 (en) 2016-08-11
BR112012012358B1 (pt) 2020-12-08
CN102724964A (zh) 2012-10-10
CN113105346A (zh) 2021-07-13
PT2503990E (pt) 2013-09-03
NZ600334A (en) 2014-10-31
CA2781718A1 (en) 2011-05-26
IL219928A (en) 2016-03-31
MX2012005939A (es) 2012-06-25

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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