Process and novel polymorphic form of vortioxetine and its pharmaceutically acceptable salts
AssigneeApicore US LLC
InventorsRavishanker Kovi, Jayaraman Rao Kannapan, Ananda Babu Thirunavakarasu, Veerabhadra Rao Bobbili, Gaurav Yadav
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Abstract
Processes are disclosed for making vortioxetine and pharmaceutically acceptable salts thereof. A propylene glycol solvate of vortioxetine hydrobromide is disclosed. A novel crystalline form of vortioxetine hydrobromide propylene glycol solvate, designated form AC1, is disclosed along with a method for making same. Form AC1 may be characterized by an x-ray powder diffraction pattern with peaks at about 19.64, 22.85, 25.51, 29.57, 30.18±0.2 degrees 2-theta.
Claims4
A process for preparing vortioxetine hydrobromide propylene glycol solvate form AC1 comprising the steps of:
- a. combining vortioxetine hydrobromide and propylene glycol to obtain a solution of vortioxetine hydrobromide in propylene glycol;
- b. maintaining the solution of step a) at a temperature of about 0° C. to about 150° C.;
- and
- c. isolating vortioxetine hydrobromide propylene glycol solvate form AC1.
Crystalline vortioxetine hydrobromide propylene glycol solvate form AC1 characterized by data selected from:
- an x-ray powder diffraction pattern with peaks at about 19.82, 20.97, 23.06, 25.7, 29.77±0.2 degrees 2-theta;
- an x-ray powder diffraction pattern with peaks substantially as depicted in FIG. 1;
- or a combination thereof.
Crystalline vortioxetine hydrobromide propylene glycol solvate form AC1 characterized by an x-ray powder diffraction pattern with peaks at about 19.64, 22.85, 25.51, 29.57, 30.18±0.2 degrees 2-theta.
Crystalline vortioxetine hydrobromide propylene glycol solvate form AC1 characterized by an x-ray powder diffraction pattern with peaks substantially as depicted in FIG. 3.
Dependencies are inferred from the claim text.