HRP20130773T1 - Postupak za pripremu kompleksa gadobenat dimeglumina u äśvrstom obliku - Google Patents
Postupak za pripremu kompleksa gadobenat dimeglumina u äśvrstom obliku Download PDFInfo
- Publication number
- HRP20130773T1 HRP20130773T1 HRP20130773AT HRP20130773T HRP20130773T1 HR P20130773 T1 HRP20130773 T1 HR P20130773T1 HR P20130773A T HRP20130773A T HR P20130773AT HR P20130773 T HRP20130773 T HR P20130773T HR P20130773 T1 HRP20130773 T1 HR P20130773T1
- Authority
- HR
- Croatia
- Prior art keywords
- liquid composition
- gadobenate dimeglumine
- solid form
- aqueous solution
- preparation
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims 12
- OCDAWJYGVOLXGZ-VPVMAENOSA-K gadobenate dimeglumine Chemical compound [Gd+3].CNC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO.CNC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO.OC(=O)CN(CC([O-])=O)CCN(CC([O-])=O)CCN(CC(O)=O)C(C([O-])=O)COCC1=CC=CC=C1 OCDAWJYGVOLXGZ-VPVMAENOSA-K 0.000 title claims 7
- 229940096814 gadobenate dimeglumine Drugs 0.000 title claims 7
- 239000007787 solid Substances 0.000 title claims 6
- 238000002360 preparation method Methods 0.000 title claims 3
- 239000007788 liquid Substances 0.000 claims 6
- 239000000203 mixture Substances 0.000 claims 6
- 239000007864 aqueous solution Substances 0.000 claims 4
- 238000001694 spray drying Methods 0.000 claims 3
- 239000008365 aqueous carrier Substances 0.000 claims 2
- 150000001875 compounds Chemical class 0.000 claims 2
- 239000002245 particle Substances 0.000 claims 2
- 239000007983 Tris buffer Substances 0.000 claims 1
- 239000002253 acid Substances 0.000 claims 1
- 238000000889 atomisation Methods 0.000 claims 1
- 239000012530 fluid Substances 0.000 claims 1
- 239000000843 powder Substances 0.000 claims 1
- 239000000243 solution Substances 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical group O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
- 239000008215 water for injection Substances 0.000 claims 1
- 239000004552 water soluble powder Substances 0.000 claims 1
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
- 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
-
- 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
-
- 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)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Dermatology (AREA)
- Nanotechnology (AREA)
- Engineering & Computer Science (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)
Claims (15)
1. Postupak za pripremu čvrstog oblika spoja gadobenat dimeglumina formule (I):
[image]
Formula (I)
koji sadrži sušenje putem raspršivanja tekuće kompozicije navedenog spoja.
2. Postupak prema patentnom zahtjevu 1, naznačen time što navedena tekuća kompozicija ima koncentraciju od najmanje 0.2 M.
3. Postupak prema patentnom zahtjevu 2, naznačen time što je navedena koncentracija sadržana od 0.45 M do 0.55 M.
4. Postupak prema bilo kojem od patentnih zahtjeva od 1 do 3, naznačen time što je tekuća kompozicija – vodena otopina.
5. Postupak prema patentnom zahtjevu 4, naznačen time što je navedena vodena otopina – pročišćena vodena otopina.
6. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time što je temperatura na ulazu (T-ulaz) uređaja za sušenje raspršivanjem iznosi od 140°C do 280°C, i temperatura na izlazu (T-izlaz) iznosi od 70°C do 120°C.
7. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time što sadrži atomizaciju tekuće kompozicije prema patentnom zahtjevu 1 uporabom mlaznice pod tlakom ili dvofluidne mlaznice.
8. Čvrsti oblik u prahu gadobenat dimeglumina koji se može dobiti pomoću postupka prema bilo kojem od patentnih zahtjeva od 1 do 7.
9. Čvrsti oblik gadobenat dimeglumina prema patentnom zahtjevu 8, naznačen time što je to prah topljiv u vodi koji sadrži gadobenat dimeglumin koji ima veličinu čestica od 1 µm do 200 µm.
10. Čvrsti oblik gadobenat dimeglumina prema patentnom zahtjevu 9, naznačen time što je veličina čestica od 20 µm do 70 µm.
11. Farmaceutski komplet koji sadrži prvi kontejner koji sadrži raspršivanjem osušen gadobenat dimeglumin prema bilo kojem od patentnih zahtjeva od 8 do 10, i drugi kontejner koji sadrži fiziološki prihvatljiv vodeni nosač.
12. Farmaceutski komplet prema patentnom zahtjevu 11, naznačen time što je navedeni fiziološki prihvatljiv vodeni nosač – voda za injekciju.
13. Postupak za pripremu čvrstog oblika 4-karboksi-5,8,11-tris(karboksimetil)-1-fenil-2-oksa-5,8,11-triazatridekan-13-ske kiseline, naznačen sušenjem putem raspršivanja tekuće kompozicije navedenog spoja.
14. Postupak prema patentnom zahtjevu 13, naznačen time što je navedena tekuća kompozicija – vodena otopina.
15. Postupak prema patentnim zahtjevima 13-14, naznačen time što je koncentracija navedene otopine od 7% tež./tež. do 14% tež./tež.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
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 (1)
Publication Number | Publication Date |
---|---|
HRP20130773T1 true HRP20130773T1 (hr) | 2013-11-08 |
Family
ID=42077873
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20130773AT HRP20130773T1 (hr) | 2009-11-23 | 2013-08-16 | Postupak za pripremu kompleksa gadobenat dimeglumina u äśvrstom obliku |
Country Status (21)
Country | Link |
---|---|
US (2) | US20120232151A1 (hr) |
EP (2) | EP2327395A1 (hr) |
JP (1) | JP5607746B2 (hr) |
KR (2) | KR101624504B1 (hr) |
CN (3) | CN113105346A (hr) |
AU (1) | AU2010320832B2 (hr) |
BR (1) | BR112012012358B8 (hr) |
CA (1) | CA2781718C (hr) |
CY (1) | CY1114342T1 (hr) |
DK (1) | DK2503990T3 (hr) |
ES (1) | ES2426271T3 (hr) |
HR (1) | HRP20130773T1 (hr) |
IL (1) | IL219928A (hr) |
MX (1) | MX2012005939A (hr) |
NZ (1) | NZ600334A (hr) |
PL (1) | PL2503990T3 (hr) |
PT (1) | PT2503990E (hr) |
RS (1) | RS52915B (hr) |
RU (1) | RU2539576C2 (hr) |
SI (1) | SI2503990T1 (hr) |
WO (1) | WO2011061341A1 (hr) |
Families Citing this family (3)
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)
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 |
CA2201750A1 (en) | 1994-10-03 | 1996-04-11 | Alan C. Rosenquist | 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 |
-
2009
- 2009-11-23 EP EP09176713A patent/EP2327395A1/en not_active Withdrawn
-
2010
- 2010-11-23 MX MX2012005939A patent/MX2012005939A/es active IP Right Grant
- 2010-11-23 RU RU2012125964/04A patent/RU2539576C2/ru active
- 2010-11-23 CN CN202110457242.3A patent/CN113105346A/zh active Pending
- 2010-11-23 WO PCT/EP2010/067981 patent/WO2011061341A1/en active Application Filing
- 2010-11-23 CA CA2781718A patent/CA2781718C/en active Active
- 2010-11-23 CN CN201710218840.9A patent/CN106986784A/zh active Pending
- 2010-11-23 KR KR1020127015988A patent/KR101624504B1/ko active IP Right Grant
- 2010-11-23 JP JP2012539358A patent/JP5607746B2/ja active Active
- 2010-11-23 PL PL10781898T patent/PL2503990T3/pl unknown
- 2010-11-23 AU AU2010320832A patent/AU2010320832B2/en active Active
- 2010-11-23 RS RS20130346A patent/RS52915B/en unknown
- 2010-11-23 US US13/510,409 patent/US20120232151A1/en not_active Abandoned
- 2010-11-23 SI SI201030311T patent/SI2503990T1/sl unknown
- 2010-11-23 CN CN2010800595178A patent/CN102724964A/zh active Pending
- 2010-11-23 ES ES10781898T patent/ES2426271T3/es active Active
- 2010-11-23 KR KR1020167008973A patent/KR20160043137A/ko not_active Application Discontinuation
- 2010-11-23 BR BR112012012358A patent/BR112012012358B8/pt active IP Right Grant
- 2010-11-23 EP EP10781898.1A patent/EP2503990B1/en active Active
- 2010-11-23 NZ NZ600334A patent/NZ600334A/en unknown
- 2010-11-23 DK DK10781898.1T patent/DK2503990T3/da active
- 2010-11-23 PT PT107818981T patent/PT2503990E/pt unknown
-
2012
- 2012-05-22 IL IL219928A patent/IL219928A/en active IP Right Grant
-
2013
- 2013-08-02 CY CY20131100662T patent/CY1114342T1/el unknown
- 2013-08-16 HR HRP20130773AT patent/HRP20130773T1/hr unknown
-
2016
- 2016-04-15 US US15/130,160 patent/US9795695B2/en active Active
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