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US 10,370,359 B2Granted
Process for the preparation of crystalline dexlansoprazole
AssigneeDipharma Francis S.R.L.
InventorsAlessandro Restelli, Alessio Bove, Gabriele Razzetti
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Abstract
The present invention relates to a process for the preparation of anhydrous crystalline 2-(R)-[(3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl)methyl)sulfinyl]-1H-benzimidazole (dexlansoprazole).
Claims15
A process for the preparation of crystalline anhydrous dexlansoprazole, characterized by an XRPD pattern having peaks at 7.5, 11.4, 13.1, 13.5, 15.1, 15.4, 17.3, 20.0, 21.7, 22.5, 24.0, 26.1, 27.3 and 28.6±0.2° in 2θ, comprising:
- a) dispersing dexlansoprazole in one or more C5-C9 alkanes or a mixture comprising one or more C5-C9 alkanes and one or more C1-C6 alcohols at a temperature of up to 50° C. to produce a dispersion;
- b) cooling the dispersion to form a precipitate of crystalline anhydrous dexlansoprazole or
- azeotropically distilling the dispersion at a temperature of up to 50° C. or
- azeotropically distilling the dispersion at a temperature of up to 50° C. and cooling the dispersion to form a precipitate of crystalline anhydrous dexlansoprazole;
- c) recovering the solid;
- and
- wherein the process does not comprise the step of complete dissolution of dexlansoprazole in an alcoholic solvent.
4 more elements
Dependencies are inferred from the claim text.