DK2799089T3 - Fremgangsmåde til fremstilling af en farmaceutisk kontrastmiddelformulering - Google Patents
Fremgangsmåde til fremstilling af en farmaceutisk kontrastmiddelformulering Download PDFInfo
- Publication number
- DK2799089T3 DK2799089T3 DK14165006.9T DK14165006T DK2799089T3 DK 2799089 T3 DK2799089 T3 DK 2799089T3 DK 14165006 T DK14165006 T DK 14165006T DK 2799089 T3 DK2799089 T3 DK 2799089T3
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- DK
- Denmark
- Prior art keywords
- free
- lanthanide
- chelate
- macrocyclic chelate
- mol
- Prior art date
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- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/28—Compounds containing heavy metals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
-
- 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
- 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
- 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
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/15—Medicinal preparations ; Physical properties thereof, e.g. dissolubility
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Pharmacology & Pharmacy (AREA)
- Radiology & Medical Imaging (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Dermatology (AREA)
- Molecular Biology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Physics & Mathematics (AREA)
- Immunology (AREA)
- Pathology (AREA)
- Food Science & Technology (AREA)
- Biophysics (AREA)
- Physics & Mathematics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Organic Chemistry (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
Claims (12)
1. Fremgangsmåde til fremstilling af en flydende farmaceutisk formulering, hvilken formulering indeholder et kompleks af makrocyklisk chelat med et lanthanid og en mol/mol-mængde af frit makrocyklisk chelat på mellem 0,002% og 0,4%, hvilken fremgangsmåde omfatter følgende successive trin: b) fremstilling af en flydende farmaceutisk sammensætning, hvilken sammensætning indeholder komplekset af makrocyklisk chelat med et lanthanid og frit makrocyklisk chelat, der ikke forefindes i form af en excipiens X[X',L] hvor L er det makrocykliske chelat, og X og X' er en metalion, navnlig valgt uafhængigt blandt calcium, natrium, zink og magnesium og/eller frit lanthanid, ved blanding af en opløsning af frit DOTA som det frie makrocykliske chelat og frit gadolinium som det frie lanthanid til opnåelse af kompleksdannelse af lanthanidet med det makrocykliske chelat, hvor mængderne af frit makrocyklisk chelat og frit lanthanid er sådan, at alt lanthanid kompleksbindes og Cch i > Ct Ch ir idet CGh i er koncentrationen af frit makrocyklisk chelat, og Ct Ch i er målkoncentrationen af det frie makrocykliske chelat i den endelige flydende farmaceutiske formulering, hvor Ct ch i er valgt fra intervallet mellem 0,002% og 0,4% mol/mol; c) måling i den farmaceutiske formulering opnået i trin b) af CCh ir idet koncentrationen af frit lanthanid Cian i er lig med 0; d) justering af CGh i og Cian i ved eliminering af frit makrocyklisk chelat fra og/eller ved tilsætning af frit lanthanid til og/eller ved modificering af pH i formuleringen opnået i trin b) til opnåelse af CGh i = Ct ch i og Cian i = 0, hvor Ct ch i er målkoncentrationen af det frie makrocykliske chelat i den endelige flydende farmaceutiske formulering og er valgt fra intervallet mellem 0,002% og 0,4% mol/mol, hvor mængden af frit makrocyklisk chelat i den endelige flydende farmaceutiske formulering svarer til andelen af frit makrocyklisk chelat i forhold til mængden af kompleksbundet makrocyklisk chelat DOTA-Gd i den endelige flydende farmaceutiske formulering i mol/mol, hvor det makrocykliske chelat er DOTA, og lanthanidet er gadolinium.
2. Fremgangsmåde ifølge krav 1, kendetegnet ved, at mol/mol-mængden af frit makrocyklisk chelat er på mellem 0,025% og 0,25%.
3. Fremgangsmåde ifølge et hvilket som helst af kravene 1 og 2, kendetegnet ved, at den farmaceutiske formulering er en farmaceutisk formulering af megluminsaltet af et DOTA-gadolinium-kompleks.
4. Fremgangsmåde ifølge krav 3, kendetegnet ved, at justeringstrinet d) i slutningen omfatter et trin til justering af pH og af volumenet med meglumin.
5. Fremgangsmåde ifølge et hvilket som helst af kravene 1-4, kendetegnet ved, at trin b) udføres ved en temperatur på mellem 60°C og 100°C, med fordel 80°C.
6. Fremgangsmåde ifølge et hvilket som helst af kravene 1 til 5, kendetegnet ved, at de tilsatte mængder af frit makrocyklisk chelat og frit lanthanid i trin b) er sådan, at mol/mol-forholdet mellem frit makrocyklisk chelat og frit lanthanid er mellem 1,001 og 1,3.
7. Fremgangsmåde ifølge et hvilket som helst af kravene 1 til 6, kendetegnet ved, at de tilsatte mængder af frit makrocyklisk chelat og frit lanthanid i trin b) er sådan, at mol/mol-forholdet mellem frit makrocyklisk chelat og frit lanthanid er mellem 1,005 og 1,02.
8. Fremgangsmåde ifølge et hvilket som helst af kravene 1 til 7, kendetegnet ved, at mængden af calcium i den flydende farmaceutiske formulering, der skal administreres til patienten, er mindre end 50 ppm, fordelagtigt mindre end 20 ppm, mere fordelagtigt mindre end 5 ppm.
9. Fremgangsmåde ifølge krav 8, kendetegnet ved, at mængden af calcium i den flydende farmaceutiske formulering, der skal administreres til patienten, er mindre end 50 ppm, og ved at mængden af calcium i bestanddelene, der anvendes til den farmaceutiske opløsning i trin b) , nemlig DOTA-pulver, vand og meglumin, er mindre end 20 ppm, fordelagtigt mindre end 15 ppm.
10. Fremgangsmåde ifølge et hvilket som helst af kravene 8 eller 9, kendetegnet ved, at den inden trin c) omfatter et mellemliggende trin b2) til måling af mængden af calcium og, når det er relevant, til fjernelse af det overskydende calcium.
11. Fremgangsmåde ifølge et hvilket som helst af kravene Ι-ΙΟ, kendetegnet ved, at den omfatter et yderligere trin e) til kontrol af Cch i og Cian i.
12. Fremgangsmåde ifølge et hvilket som helst af kravene 1 til 11, kendetegnet ved, at trin b) udføres ved en temperatur på mellem 60°C og 100°C, og ved at den farmaceutiske formulering herefter nedkøles før justeringstrinet d).
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR0851055A FR2927539B1 (fr) | 2008-02-19 | 2008-02-19 | Procede de preparation d'une formulation pharmaceutique d'agents de contraste. |
EP08154745 | 2008-04-17 | ||
US12/155,997 US20090208421A1 (en) | 2008-02-19 | 2008-06-12 | Process for preparing a pharmaceutical formulation of contrast agents |
EP13154448.8A EP2591807A1 (en) | 2008-02-19 | 2009-02-18 | Process for preparing a pharmaceutical formulation of contrast agents |
Publications (1)
Publication Number | Publication Date |
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DK2799089T3 true DK2799089T3 (da) | 2016-11-21 |
Family
ID=40955314
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK14165006.9T DK2799089T3 (da) | 2008-02-19 | 2009-02-18 | Fremgangsmåde til fremstilling af en farmaceutisk kontrastmiddelformulering |
DK14165008.5T DK2799090T4 (da) | 2008-02-19 | 2009-02-18 | Fremgangsmåde til fremstilling af en farmaceutisk kontrastmiddelformulering |
DK09712403.6T DK2242515T3 (da) | 2008-02-19 | 2009-02-18 | Fremgangsmåde til fremstilling af en farmaceutisk kontrastmiddelformulering |
Family Applications After (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK14165008.5T DK2799090T4 (da) | 2008-02-19 | 2009-02-18 | Fremgangsmåde til fremstilling af en farmaceutisk kontrastmiddelformulering |
DK09712403.6T DK2242515T3 (da) | 2008-02-19 | 2009-02-18 | Fremgangsmåde til fremstilling af en farmaceutisk kontrastmiddelformulering |
Country Status (17)
Country | Link |
---|---|
US (6) | US20090208421A1 (da) |
EP (6) | EP2242515B9 (da) |
JP (3) | JP5469615B2 (da) |
KR (1) | KR101063060B1 (da) |
CN (1) | CN101977633B (da) |
BR (1) | BRPI0908221B1 (da) |
CA (1) | CA2714118C (da) |
CY (2) | CY1115259T1 (da) |
DE (1) | DE202008010019U1 (da) |
DK (3) | DK2799089T3 (da) |
ES (3) | ES2477541T3 (da) |
HR (2) | HRP20140537T1 (da) |
HU (2) | HUE031091T2 (da) |
LT (2) | LT2799089T (da) |
PL (3) | PL2799090T5 (da) |
PT (3) | PT2799089T (da) |
WO (1) | WO2009103744A2 (da) |
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US20090208421A1 (en) | 2008-02-19 | 2009-08-20 | Dominique Meyer | Process for preparing a pharmaceutical formulation of contrast agents |
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2008
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