Process for preparing a pharmaceutical formulation of contrast agents
US9655983B2 · kind B2 · utility
Assignee
Inventors
Key dates
| Filing date | Feb 18, 2009 |
| Grant date | May 23, 2017 |
| Priority date | — |
| Expiry date | Feb 18, 2029 |
Classification
- Technology area (CPC G)Physics
- CPC primaryG01N33/15
- WIPO fieldPharmaceuticals
- WIPO sectorChemistry
Abstract
The invention relates to a process for preparing a liquid pharmaceutical formulation containing a complex of macrocyclic chelate with a lanthanide and a mol/mol amount of free macrocyclic chelate of between 0.002% and 0.4%, advantageously between 0.02% and 0.3% and very advantageously between 0.025% and 0.25%, the macrocyclic chelate advantageously being chosen from DOTA, NOTA, DOTAGA, DO3A, BT-DO3A, HP-DO3A and PCTA, and is preferably DOTA, the said process comprising the following successive steps: b) preparation of a liquid pharmaceutical composition containing, firstly, the complex of macrocyclic chelate with a lanthanide, and, secondly, free macrocyclic chelate and/or free lanthanide; c) measurement in the pharmaceutical formulation obtained in step b) of the concentration of free macrocyclic chelate C ch1 and/or of free lanthanide C lan1; d) adjustment of C ch1 and/or of C lan1 so as to obtain C ch1=C tch1 and C lan1=0, wherein C t ch1 is the target concentration of free macrocyclic chelate in the final liquid pharmaceutical formulation.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.