CY1123317T1 - Μεθοδος για την παραγωγη κρυσταλλικης μορφης της τροποποιησης α της καλκοβουτρολης - Google Patents
Μεθοδος για την παραγωγη κρυσταλλικης μορφης της τροποποιησης α της καλκοβουτροληςInfo
- Publication number
- CY1123317T1 CY1123317T1 CY20201100709T CY201100709T CY1123317T1 CY 1123317 T1 CY1123317 T1 CY 1123317T1 CY 20201100709 T CY20201100709 T CY 20201100709T CY 201100709 T CY201100709 T CY 201100709T CY 1123317 T1 CY1123317 T1 CY 1123317T1
- Authority
- CY
- Cyprus
- Prior art keywords
- modification
- crystalline form
- calcobutrol
- producing crystalline
- formula
- Prior art date
Links
- 238000012986 modification Methods 0.000 title abstract 3
- 230000004048 modification Effects 0.000 title abstract 3
- 238000004519 manufacturing process Methods 0.000 title abstract 2
- GCLKDXFGQNCFQW-CTHHTMFSSA-L calcium 2-[4,10-bis(carboxylatomethyl)-7-[(2R,3S)-1,3,4-trihydroxybutan-2-yl]-1,4,7,10-tetrazacyclododec-1-yl]acetate hydron Chemical compound [H+].[Ca+2].OC[C@@H](O)[C@@H](CO)N1CCN(CC([O-])=O)CCN(CC([O-])=O)CCN(CC([O-])=O)CC1 GCLKDXFGQNCFQW-CTHHTMFSSA-L 0.000 title 1
- 229950006450 calcobutrol Drugs 0.000 title 1
- MUBZPKHOEPUJKR-UHFFFAOYSA-N Oxalic acid Chemical compound OC(=O)C(O)=O MUBZPKHOEPUJKR-UHFFFAOYSA-N 0.000 abstract 3
- 150000001875 compounds Chemical class 0.000 abstract 2
- ZPDFIIGFYAHNSK-CTHHTMFSSA-K 2-[4,10-bis(carboxylatomethyl)-7-[(2r,3s)-1,3,4-trihydroxybutan-2-yl]-1,4,7,10-tetrazacyclododec-1-yl]acetate;gadolinium(3+) Chemical compound [Gd+3].OC[C@@H](O)[C@@H](CO)N1CCN(CC([O-])=O)CCN(CC([O-])=O)CCN(CC([O-])=O)CC1 ZPDFIIGFYAHNSK-CTHHTMFSSA-K 0.000 abstract 1
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 abstract 1
- 229910052688 Gadolinium Inorganic materials 0.000 abstract 1
- 229910052791 calcium Inorganic materials 0.000 abstract 1
- 239000011575 calcium Substances 0.000 abstract 1
- 159000000007 calcium salts Chemical class 0.000 abstract 1
- 238000002425 crystallisation Methods 0.000 abstract 1
- 230000008025 crystallization Effects 0.000 abstract 1
- ZPDFIIGFYAHNSK-UHFFFAOYSA-K gadobutrol Chemical compound [Gd+3].OCC(O)C(CO)N1CCN(CC([O-])=O)CCN(CC([O-])=O)CCN(CC([O-])=O)CC1 ZPDFIIGFYAHNSK-UHFFFAOYSA-K 0.000 abstract 1
- 229960003411 gadobutrol Drugs 0.000 abstract 1
- UIWYJDYFSGRHKR-UHFFFAOYSA-N gadolinium atom Chemical compound [Gd] UIWYJDYFSGRHKR-UHFFFAOYSA-N 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 235000006408 oxalic acid Nutrition 0.000 abstract 1
- 238000002360 preparation method Methods 0.000 abstract 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07F—ACYCLIC, CARBOCYCLIC OR HETEROCYCLIC COMPOUNDS CONTAINING ELEMENTS OTHER THAN CARBON, HYDROGEN, HALOGEN, OXYGEN, NITROGEN, SULFUR, SELENIUM OR TELLURIUM
- C07F3/00—Compounds containing elements of Groups 2 or 12 of the Periodic Table
- C07F3/04—Calcium compounds
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D257/00—Heterocyclic compounds containing rings having four nitrogen atoms as the only ring hetero atoms
- C07D257/02—Heterocyclic compounds containing rings having four nitrogen atoms as the only ring hetero atoms not condensed with other rings
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
- C07B2200/00—Indexing scheme relating to specific properties of organic compounds
- C07B2200/13—Crystalline forms, e.g. polymorphs
Landscapes
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicinal Chemistry (AREA)
- Radiology & Medical Imaging (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
- Polysaccharides And Polysaccharide Derivatives (AREA)
- Saccharide Compounds (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Abstract
Περιγράφεται μία μέθοδος για την παρασκευή υψηλής καθαρότητας ένωσης του τύπου (Ι) σε κρυσταλλική μορφή της τροποποίησης Α. Σε αυτό, εκκινώντας από υψηλής καθαρότητας γαδοβουτρόλη, αφαιρείται το γαδολίνιο μέσω αποσυμπλοκοποίησης με οξαλικό οξύ και στη συνέχεια με άλας ασβεστίου παράγεται το σύμπλοκο ασβεστίου σε υψηλή καθαρότητα. Κατά τη διάρκεια της κρυσταλλοποίησης, τίθεται υδατικό ισοδύναμο 9-11 βάρους %. Η κρυσταλλική μορφή της τροποποίησης Α της ένωσης του τύπου (Ι) χρησιμοποιείται στην παραγωγή Gadovist.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP16190812 | 2016-09-27 | ||
PCT/EP2017/072683 WO2018059914A1 (en) | 2016-09-27 | 2017-09-11 | Method for producing the crystalline form of modification a of calcobutrol |
Publications (1)
Publication Number | Publication Date |
---|---|
CY1123317T1 true CY1123317T1 (el) | 2021-12-31 |
Family
ID=57003447
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CY20201100709T CY1123317T1 (el) | 2016-09-27 | 2020-07-30 | Μεθοδος για την παραγωγη κρυσταλλικης μορφης της τροποποιησης α της καλκοβουτρολης |
Country Status (26)
Country | Link |
---|---|
US (2) | US10793532B2 (el) |
EP (1) | EP3519394B1 (el) |
JP (2) | JP7053590B2 (el) |
KR (1) | KR102395523B1 (el) |
CN (1) | CN109803958B (el) |
AR (1) | AR109729A1 (el) |
AU (1) | AU2017333698B2 (el) |
BR (1) | BR112019006066A2 (el) |
CA (1) | CA3038036C (el) |
CY (1) | CY1123317T1 (el) |
DK (1) | DK3519394T3 (el) |
ES (1) | ES2809736T3 (el) |
HR (1) | HRP20200922T1 (el) |
HU (1) | HUE050553T2 (el) |
IL (1) | IL265536B (el) |
LT (1) | LT3519394T (el) |
MX (1) | MX2019003540A (el) |
NZ (1) | NZ751256A (el) |
PL (1) | PL3519394T3 (el) |
PT (1) | PT3519394T (el) |
RS (1) | RS60392B1 (el) |
SG (1) | SG11201901460UA (el) |
SI (1) | SI3519394T1 (el) |
TW (1) | TWI765913B (el) |
UY (1) | UY37421A (el) |
WO (1) | WO2018059914A1 (el) |
Families Citing this family (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
BR112019006066A2 (pt) * | 2016-09-27 | 2019-06-18 | Bayer Pharma AG | método para produzir a forma cristalina de modificação a de calcobutrol |
US20210380542A1 (en) * | 2018-10-24 | 2021-12-09 | Biophore India Pharmaceuticals Pvt. Ltd | Novel process for the preparation of macrocyclic chelant 2,2',2''-(10-(2-hydroxypropyl)-1,4,7,10-tetra azacyclododecane-1,4,7-triyl) triacetic acid and it's complexes with paramagnetic metal ions |
CN111039885B (zh) * | 2019-12-06 | 2021-03-05 | 广州康瑞泰药业有限公司 | 一种制备高纯度考布曲钙的方法 |
KR20210112910A (ko) * | 2020-03-06 | 2021-09-15 | 주식회사 엔지켐생명과학 | 가도부트롤 주사제 제조를 위한 부형제인 칼코부트롤의 제조 방법 |
KR20210114742A (ko) * | 2020-03-11 | 2021-09-24 | 주식회사 엔지켐생명과학 | 칼테리돌의 제조방법 |
CN114573522A (zh) * | 2020-11-30 | 2022-06-03 | 江苏恒瑞医药股份有限公司 | 一种考布曲钙的新晶型及其制备方法 |
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US4284620A (en) | 1979-03-23 | 1981-08-18 | Mallinckrodt, Inc. | N-(2-Hydroxyethyl)-2,4,6-triiodo-3,5-bis-(2-keto-L-gulonamido)benzamide and radiological compositions containing same |
NO161560C (no) | 1980-04-17 | 1989-09-06 | Univ California | Symmetriske trijodisoftaldiamid-derivater og roentgenkontrastmidler inneholdende disse. |
DE3150916A1 (de) | 1981-12-18 | 1983-06-30 | Schering Ag, 1000 Berlin Und 4619 Bergkamen | N-hydroxyaethylierte 2,4,6-trijodaminoisiophthalsaeure-bis- trihydroxybutylamide, deren herstellung und diese enthaltende roentgenkontrastmittel" |
US5064633A (en) | 1984-06-04 | 1991-11-12 | The Dow Chemical Company | Macrocyclic aminophosphonic acid complexes, their formulations and use |
US5059412A (en) | 1984-06-04 | 1991-10-22 | The Dow Chemical Company | Macrocyclic aminophosphonic acid complexes for the treatment of calcific tumors |
US4885363A (en) | 1987-04-24 | 1989-12-05 | E. R. Squibb & Sons, Inc. | 1-substituted-1,4,7-triscarboxymethyl-1,4,7,10-tetraazacyclododecane and analogs |
MX174467B (es) | 1986-01-23 | 1994-05-17 | Squibb & Sons Inc | 1,4,7-triscarboximetil-1,4,7,10-tetraazaciclodo decano substituido en 1 y compuestos analogos |
DE3625417C2 (de) | 1986-07-28 | 1998-10-08 | Schering Ag | Tetraazacyclododecan-Derivate |
DE3640708C2 (de) | 1986-11-28 | 1995-05-18 | Schering Ag | Verbesserte metallhaltige Pharmazeutika |
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 |
PT97124A (pt) | 1990-03-23 | 1991-12-31 | Gist Brocades Nv | Processo para a prparacao de composicoes inibidoras de interleucina - 6 (il-6) |
DE4035760A1 (de) | 1990-11-08 | 1992-05-14 | Schering Ag | Mono-n-substituierte 1,4,7,10-tetraazacyclododecan-derivate, 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 |
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DE102009053171B4 (de) * | 2009-11-04 | 2011-07-21 | Bayer Schering Pharma Aktiengesellschaft, 13353 | Verfahren zur Herstellung des Calcium-Komplexes von Dihydroxy-hydroxy-methylpropyl-tetraazacyclododecan-triessigsäure (Calcobutrol) |
ES2780599T3 (es) * | 2011-04-21 | 2020-08-26 | Bayer Ip Gmbh | Preparación de gadobutrol de alta pureza |
JP2014516080A (ja) * | 2011-06-08 | 2014-07-07 | エスティーアイ ファーマ, エルエルシー | 一日一回の投与のための吸収が制御された水溶性の薬学的に活性な有機化合物製剤 |
KR101693400B1 (ko) | 2014-09-17 | 2017-01-05 | 에스티팜 주식회사 | 칼코부트롤의 제조방법 |
CN105037288B (zh) * | 2015-07-23 | 2017-11-03 | 上海现代制药海门有限公司 | 一种布醇的制备方法 |
CN106187930B (zh) * | 2016-07-12 | 2018-10-19 | 嘉实(湖南)医药科技有限公司 | 高纯度考布曲钙的制备方法 |
BR112019006066A2 (pt) | 2016-09-27 | 2019-06-18 | Bayer Pharma AG | método para produzir a forma cristalina de modificação a de calcobutrol |
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2017
- 2017-09-11 BR BR112019006066A patent/BR112019006066A2/pt not_active Application Discontinuation
- 2017-09-11 HU HUE17768733A patent/HUE050553T2/hu unknown
- 2017-09-11 IL IL265536A patent/IL265536B/en unknown
- 2017-09-11 LT LTEP17768733.2T patent/LT3519394T/lt unknown
- 2017-09-11 SG SG11201901460UA patent/SG11201901460UA/en unknown
- 2017-09-11 CA CA3038036A patent/CA3038036C/en active Active
- 2017-09-11 JP JP2019516489A patent/JP7053590B2/ja active Active
- 2017-09-11 WO PCT/EP2017/072683 patent/WO2018059914A1/en active Application Filing
- 2017-09-11 RS RS20200654A patent/RS60392B1/sr unknown
- 2017-09-11 CN CN201780058632.5A patent/CN109803958B/zh active Active
- 2017-09-11 PT PT177687332T patent/PT3519394T/pt unknown
- 2017-09-11 ES ES17768733T patent/ES2809736T3/es active Active
- 2017-09-11 PL PL17768733T patent/PL3519394T3/pl unknown
- 2017-09-11 US US16/336,217 patent/US10793532B2/en active Active
- 2017-09-11 KR KR1020197008763A patent/KR102395523B1/ko active IP Right Grant
- 2017-09-11 AU AU2017333698A patent/AU2017333698B2/en active Active
- 2017-09-11 MX MX2019003540A patent/MX2019003540A/es unknown
- 2017-09-11 NZ NZ751256A patent/NZ751256A/en unknown
- 2017-09-11 EP EP17768733.2A patent/EP3519394B1/en active Active
- 2017-09-11 DK DK17768733.2T patent/DK3519394T3/da active
- 2017-09-11 SI SI201730298T patent/SI3519394T1/sl unknown
- 2017-09-27 TW TW106133043A patent/TWI765913B/zh active
- 2017-09-27 UY UY0001037421A patent/UY37421A/es unknown
- 2017-09-27 AR ARP170102671A patent/AR109729A1/es unknown
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2020
- 2020-06-09 HR HRP20200922TT patent/HRP20200922T1/hr unknown
- 2020-07-30 CY CY20201100709T patent/CY1123317T1/el unknown
- 2020-09-22 US US17/028,467 patent/US11390592B2/en active Active
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2022
- 2022-03-03 JP JP2022032582A patent/JP7444914B2/ja active Active
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