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US-12180196-B2 · Dec 31, 2024 · US
US9795695B2 · US · B2
| Field | Value |
|---|---|
| Publication number | US-9795695-B2 |
| Application number | US-201615130160-A |
| Country | US |
| Kind code | B2 |
| Filing date | Apr 15, 2016 |
| Priority date | Nov 23, 2009 |
| Publication date | Oct 24, 2017 |
| Grant date | Oct 24, 2017 |
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The present invention discloses a process for the preparation of gadobenate dimeglumine complex in a solid form. In particular, said solid form is conveniently obtained by spray-drying a corresponding liquid suspension at a given temperature and concentration. The present invention is particularly advantageous for the industrial scale as the solid form may be obtained by employing water as a solvent, which is a non-toxic solvent, easy to handle and basically not requiring troublesome health or safety precautions.
Opening claim text (preview).
The invention claimed is: 1. A process for the preparation of a solid, pharmaceutical form of gadobenate dimeglumine compound of formula (I): comprising spray-drying an aqueous composition of said compound, wherein the form is a stable water soluble powder having a particle size from 1 μm to 200 μm, wherein said aqueous composition has a concentration from 0.2 M to 0.8 M gadobenate dimeglumine, and wherein the inlet temperature (T-inlet) of the spray-drier is comprised from 140° C. to 200° C. and the outlet temperature (T-outlet) is comprised from 70° C. to 120° C. 2. The process according to claim 1 , wherein said concentration is comprised from 0.45 M to 0.55 M. 3. The process according to claim 1 , wherein said aqueous composition is a purified water solution. 4. The process according to claim 1 , comprising an atomization of the aqueous composition by using a pressure or a two-fluid nozzle. 5. The process according to claim 3 , comprising an atomization of the aqueous composition by using a pressure or a two-fluid nozzle.
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