Method of production of a methionine salt
US-9403764-B2 · Aug 2, 2016 · US
US9688625B2 · US · B2
| Field | Value |
|---|---|
| Publication number | US-9688625-B2 |
| Application number | US-201515124679-A |
| Country | US |
| Kind code | B2 |
| Filing date | Mar 26, 2015 |
| Priority date | Mar 27, 2014 |
| Publication date | Jun 27, 2017 |
| Grant date | Jun 27, 2017 |
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The present invention refers to an amorphous form of a thiocolchicine derivative, IDN 5404, to a process for producing it and to pharmaceutical compositions thereof. The amorphous form is characterized by the XRPD pattern, DSC profile and/or TG/DTA profile.
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The invention claimed is: 1. An amorphous compound of formula (I): having the XRPD pattern shown in FIG. 1 . 2. The amorphous compound according to claim 1 having a DSC profile characterized by a glass transition with onset at 186.9° C. and endset at 194.5° C. recorded with a linear heating rate of 10° C./min. 3. The amorphous compound according to claim 1 having a TG/DTA profile characterized by an endothermic signal between 185.4° C. and 195.4° C. recorded with a linear heating rate of 10° C./min. 4. A process of preparing the amorphous compound of formula (I), as defined in claim 1 , comprising the steps of: (a) dissolving the crude compound of formula (I) in DMSO; (b) removing the possible residual solvents coming from the synthetic process by heating the solution at 65° C. under vacuum; (c) precipitating the amorphous compound of formula (I) by adding drop wise the solution obtained in step b) to water at 20-25° C. 5. A pharmaceutical composition comprising the amorphous compound of formula (I) according to claim 1 and a pharmaceutically acceptable carrier and/diluent. 6. The pharmaceutical composition according to claim 5 for parenteral or oral administration.
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