CY1118985T1 - Διαδικασια για την παρασκευη φαρμακοτεχνικης μορφης σκιαγραφικων παραγοντωn - Google Patents
Διαδικασια για την παρασκευη φαρμακοτεχνικης μορφης σκιαγραφικων παραγοντωnInfo
- Publication number
- CY1118985T1 CY1118985T1 CY20161101126T CY161101126T CY1118985T1 CY 1118985 T1 CY1118985 T1 CY 1118985T1 CY 20161101126 T CY20161101126 T CY 20161101126T CY 161101126 T CY161101126 T CY 161101126T CY 1118985 T1 CY1118985 T1 CY 1118985T1
- Authority
- CY
- Cyprus
- Prior art keywords
- free
- macrocyclic chelate
- mol
- lanthanum
- chelate
- Prior art date
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
- 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
-
- 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
Abstract
Η εφεύρεση σχετίζεται με μια διαδικασία για την παρασκευή μίας υγρής φαρμακοτεχνικής μορφής που περιέχει ένα σύμπλοκο μακροκυκλικών χηλικών ενώσεων με μία λανθανίδα και μία ποσότητα mol/mol ελεύθερης μακροκυκλικής χηλικής ένωσης μεταξύ 0.002% και 0.4%, με την εν λόγω διαδικασία να περιλαμβάνει τα ακόλουθα διαδοχικά βήματα: β) της παρασκευής μιας υγρής φαρμακευτικής σύνθεσης που περιέχει το σύμπλοκο της μακροκυκλικής χηλικής ένωσης με μία λανθανίδα, της ελεύθερης μακροκυκλικής χηλικής ένωσης, η οποία δεν είναι υπό την μορφή ενός εκδόχου X[X',L], στο οποίο το L είναι η μακροκυκλική χηλική ένωση και τα Χ και X' είναι ένα μεταλλικό ιόν, ειδικότερα επιλεγμένο ανεξάρτητα από ασβέστιο, νάτριο, ψευδάργυρο και μαγνήσιο, και/ή ελεύθερη λανθανίδα, μέσω της ανάμιξης ενός διαλύματος ελεύθερης μακροκυκλικής χηλικής ένωσης και ελεύθερης λανθανίδας, έτσι ώστε να ληφθεί η συμπλοκοποίηση της λανθανίδας, από την μακροκυκλική χηλική ένωση, με τις ποσότητες της ελεύθερης μακροκυκλικής χηλικής ένωσης και της ελεύθερης λανθανίδας να είναι έτσι ώστε όλη η λανθανίδα να συμπλοκοποιείται και ώστε η Cch 1 > Ct ch 1, όπου η Cch 1 είναι η συγκέντρωση της ελεύθερης μακροκυκλικής χηλικής ένωσης και η Ct ch 1 είναι η συγκέντρωση-στόχος της ελεύθερης μακροκυκλικής χηλικής ένωσης στην τελική υγρή φαρμακοτεχνική μορφή και επιλέγεται στο εύρος μεταξύ 0.002 % και 0.4 % mol/mol· γ) της μέτρησης στην φαρμακοτεχνική μορφή που λαμβάνεται στο βήμα β) της Cch 1, της συγκέντρωσης της ελεύθερης λανθανίδας C1an 1 που είναι ίση με 0· δ) της ρύθμισης της Cch 1 και/ή της C1an 1, ώστε να ληφθεί Cch 1 = Ct ch 1 και C1an 1 = 0, μέσω προσθήκης ελεύθερης λανθανίδας, στην φαρμακοτεχνική μορφή που λαμβάνεται στο βήμα β), όπου η Ct ch 1 είναι η συγκέντρωση-στόχος της ελεύθερης μακροκυκλικής χηλικής ένωσης στην τελική υγρή φαρμακοτεχνική μορφή και επιλέγεται στο εύρος μεταξύ 0.002 % και 0.4 % mol/mol, όπου η ποσότητα της ελεύθερης μακροκυκλικής χηλικής ένωσης στην τελική υγρή φαρμακοτεχνική μορφή αντιστοιχεί στην αναλογία της ελεύθερης μακροκυκλικής χηλικής ένωσης, σε σχέση με την ποσότητα της συμπλοκοποιημένης μακροκυκλικής χηλικής ένωσης στην τελική υγρή φαρμακοτεχνική μορφή.
Applications Claiming Priority (6)
| 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 |
| EP09712403.6A EP2242515B9 (en) | 2008-02-19 | 2009-02-18 | Process for preparing a pharmaceutical formulation of contrast agents |
| EP14165006.9A EP2799089B9 (en) | 2008-02-19 | 2009-02-18 | Process for preparing a pharmaceutical formulation of contrast agents |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CY1118985T1 true CY1118985T1 (el) | 2018-01-10 |
Family
ID=40955314
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CY20141100489T CY1115259T1 (el) | 2008-02-19 | 2014-07-01 | Διαδικασια για την παρασκευη φαρμακοτεχνικης μορφης σκιαγραφικων παραγοντων |
| CY20161101126T CY1118985T1 (el) | 2008-02-19 | 2016-11-03 | Διαδικασια για την παρασκευη φαρμακοτεχνικης μορφης σκιαγραφικων παραγοντωn |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CY20141100489T CY1115259T1 (el) | 2008-02-19 | 2014-07-01 | Διαδικασια για την παρασκευη φαρμακοτεχνικης μορφης σκιαγραφικων παραγοντων |
Country Status (17)
| Country | Link |
|---|---|
| US (6) | US20090208421A1 (el) |
| EP (6) | EP2591807A1 (el) |
| JP (3) | JP5469615B2 (el) |
| KR (1) | KR101063060B1 (el) |
| CN (1) | CN101977633B (el) |
| BR (1) | BRPI0908221B1 (el) |
| CA (1) | CA2714118C (el) |
| CY (2) | CY1115259T1 (el) |
| DE (1) | DE202008010019U1 (el) |
| DK (3) | DK2242515T3 (el) |
| ES (3) | ES2477541T3 (el) |
| HR (2) | HRP20140537T1 (el) |
| HU (2) | HUE030219T2 (el) |
| LT (2) | LT2799090T (el) |
| PL (3) | PL2799089T3 (el) |
| PT (3) | PT2242515E (el) |
| WO (1) | WO2009103744A2 (el) |
Families Citing this family (41)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20090208421A1 (en) | 2008-02-19 | 2009-08-20 | Dominique Meyer | Process for preparing a pharmaceutical formulation of contrast agents |
| FR2945448B1 (fr) * | 2009-05-13 | 2012-08-31 | Guerbet Sa | Procede de preparation d'une formulation pharmaceutique de chelate de lanthanide sous forme de poudre. |
| EP2338874A1 (en) | 2009-12-16 | 2011-06-29 | Bracco Imaging S.p.A | Process for the preparation of chelated compounds |
| CN105025854A (zh) * | 2013-01-07 | 2015-11-04 | 宾夕法尼亚大学董事会 | 治疗皮肤t细胞淋巴瘤的组合物和方法 |
| TW201514188A (zh) * | 2013-03-13 | 2015-04-16 | Lantheus Medical Imaging Inc | 製備釓磷維塞三鈉單水合物之方法 |
| EP2786768A1 (en) * | 2013-04-04 | 2014-10-08 | Agfa Healthcare | Process for preparing a material comprising a macrocyclic ligand and for producing a pharmaceutical formulation comprising said ligand with a lanthanide |
| DK2988756T4 (da) * | 2013-04-26 | 2022-08-08 | Guerbet Sa | Formulering af kontraststof og dertil knyttet fremstillingsfremgangsmåde |
| KR101466602B1 (ko) * | 2013-05-31 | 2014-12-01 | 동국제약 주식회사 | 메글루민 가도테레이트를 포함하는 조영제 조성물의 제조방법 |
| AT516104B1 (de) | 2014-07-31 | 2016-08-15 | Sanochemia Pharmazeutika Ag | Verfahren zum Herstellen einer flüssigen pharmazeutischen Zubereitung |
| KR101646211B1 (ko) * | 2014-11-12 | 2016-08-05 | (주)디아이테크 | 자기공명영상용 조영제의 제조방법 |
| GB201421162D0 (en) | 2014-11-28 | 2015-01-14 | Ge Healthcare As | Lanthanide complex formulations |
| GB201421163D0 (en) * | 2014-11-28 | 2015-01-14 | Ge Healthcare As | Formulations of metal complexes |
| GB201421161D0 (en) | 2014-11-28 | 2015-01-14 | Ge Healthcare As | Metal complex formulations |
| US20170035461A1 (en) * | 2015-08-03 | 2017-02-09 | Jeffery Deal | Reversible tattoo colorant and method |
| DE102015013939A1 (de) * | 2015-09-15 | 2017-03-16 | be imaging GmbH | Verfahren zur Herstellung von Gadotersäure (Gd-DOTA)- Komplexen |
| CA2997791A1 (en) | 2015-09-30 | 2017-04-06 | Duke University | Ascorbate formulations and methods of use as contrast agents |
| KR101625656B1 (ko) * | 2015-10-16 | 2016-05-30 | 최경석 | 자기공명영상용 조영제의 제조방법 |
| EP3383441A1 (en) * | 2015-11-30 | 2018-10-10 | GE Healthcare AS | Formulations comprising a combination of mri contrast agents |
| GB201610738D0 (en) | 2016-06-20 | 2016-08-03 | Ge Healthcare As | Chelate compounds |
| WO2018069176A1 (en) | 2016-10-12 | 2018-04-19 | T2Pharma Gmbh | Method of preparing formulations of lanthanide metal complexes of macrocyclic chelates |
| WO2018069179A1 (en) | 2016-10-12 | 2018-04-19 | T2Pharma Gmbh | Method of preparing formulations of lanthanide metal complexes of macrocyclic chelates |
| EP3315141B1 (de) * | 2016-10-28 | 2020-10-21 | B.E. Imaging GmbH | Verfahren zur herstellung von pharmazeutischen formulierungen enthaltend chelatkomplexe von gadolinium mit reduziertem gehalt an toxischen verunreinigungen |
| KR102464647B1 (ko) | 2016-11-28 | 2022-11-08 | 바이엘 파마 악티엔게젤샤프트 | 자기 공명 영상화에 사용하기 위한 높은 이완도 가돌리늄 킬레이트 화합물 |
| LT3558394T (lt) | 2016-12-21 | 2020-09-10 | Ge Healthcare As | Tetraazabiciklo-makrociklo pagrindu pagaminti mangano chelatiniai junginiai, tinkami mrt vaizdinimo agentams |
| WO2018125916A1 (en) * | 2016-12-29 | 2018-07-05 | Inventure, LLC | Solvent-free gadolinium contrast agents |
| US20190269805A1 (en) * | 2016-12-29 | 2019-09-05 | Inventure, LLC | Solvent-free gadolinium contrast agents |
| CN110891614A (zh) | 2017-05-05 | 2020-03-17 | 融合制药公司 | Igf-1r单克隆抗体及其用途 |
| US10093741B1 (en) | 2017-05-05 | 2018-10-09 | Fusion Pharmaceuticals Inc. | IGF-1R monoclonal antibodies and uses thereof |
| KR102612882B1 (ko) | 2017-05-05 | 2023-12-11 | 센터 포 프로브 디벨롭먼트 앤드 커머셜리제이션 | 이관능성 킬레이트 및 그의 용도의 약동학적 증진 |
| WO2019020662A1 (de) * | 2017-07-27 | 2019-01-31 | Sanochemia Pharmazeutika Ag | Zubereitung enthaltend ein kontrastmittel, und verfahren zum herstellen |
| FR3072281B1 (fr) * | 2017-10-13 | 2020-12-04 | Nh Theraguix | Nanovecteurs et utilisations, en particulier pour le traitement de tumeurs |
| WO2019122255A1 (en) | 2017-12-20 | 2019-06-27 | General Electric Company | Anionic chelate compounds |
| AT521001B1 (de) * | 2018-02-23 | 2020-10-15 | Sanochemia Pharmazeutika Ag | Herstellungsverfahren für ein Kontrastmittel |
| CA3120665A1 (en) * | 2018-11-23 | 2020-05-28 | Bayer Aktiengesellschaft | Formulation of contrast media and process of preparation thereof |
| US20200215198A1 (en) * | 2019-01-03 | 2020-07-09 | Ionpath, Inc. | Compositions and reagents for ion beam imaging |
| FR3091873B1 (fr) * | 2019-01-17 | 2020-12-25 | Guerbet Sa | Complexe de gadolinium et d’un ligand chelateur derive de pcta diastereoisomeriquement enrichi et procede de preparation et de purification |
| EP4048322A1 (en) * | 2019-10-25 | 2022-08-31 | Bracco Imaging SPA | Pharmaceutical compositions of gd-based contrast agents |
| GB201919073D0 (en) | 2019-12-20 | 2020-02-05 | Ge Healthcare As | Novel manufacturing process |
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2008
- 2008-06-12 US US12/155,997 patent/US20090208421A1/en not_active Abandoned
- 2008-07-25 DE DE202008010019U patent/DE202008010019U1/de not_active Withdrawn - After Issue
-
2009
- 2009-02-18 DK DK09712403.6T patent/DK2242515T3/da active
- 2009-02-18 DK DK14165008.5T patent/DK2799090T4/da active
- 2009-02-18 WO PCT/EP2009/051937 patent/WO2009103744A2/en active Application Filing
- 2009-02-18 CN CN2009801096136A patent/CN101977633B/zh active Active
- 2009-02-18 CA CA2714118A patent/CA2714118C/en active Active
- 2009-02-18 PT PT97124036T patent/PT2242515E/pt unknown
- 2009-02-18 JP JP2010547173A patent/JP5469615B2/ja active Active
- 2009-02-18 ES ES09712403.6T patent/ES2477541T3/es active Active
- 2009-02-18 ES ES14165006.9T patent/ES2597782T3/es active Active
- 2009-02-18 PL PL14165006T patent/PL2799089T3/pl unknown
- 2009-02-18 EP EP13154448.8A patent/EP2591807A1/en not_active Ceased
- 2009-02-18 KR KR1020107020477A patent/KR101063060B1/ko active IP Right Review Request
- 2009-02-18 EP EP09712403.6A patent/EP2242515B9/en not_active Revoked
- 2009-02-18 ES ES14165008T patent/ES2593127T5/es active Active
- 2009-02-18 EP EP16194654.6A patent/EP3159014A1/en not_active Ceased
- 2009-02-18 BR BRPI0908221-2A patent/BRPI0908221B1/pt active IP Right Grant
- 2009-02-18 EP EP19204417.0A patent/EP3620179A1/en not_active Withdrawn
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2013
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2014
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2016
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2017
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