Forms of vilazodone and processes for the preparation thereof
AssigneeApotex Inc.
InventorsWeeratunga Gamini, Murali Kondamreddy, Allan W. Rey, Cameron L. McPhail, Yajun Zhao
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Abstract
Vilazodone hydrochloride benzyl alcohol solvates are provided as well as processes for the preparation thereof.
Claims32
A crystalline benzyl alcohol solvate of vilazodone hydrochloride.
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A Form APO-I of vilazodone hydrochloride benzyl alcohol solvate characterized by a PXRD diffractogram comprising peaks, in terms of degrees 2-theta, at approximately 9.5, 10.6, 13.5, 15.6, 22.3, and 26.1.
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A process for preparation of vilazodone hydrochloride benzyl alcohol solvate, the process comprising:
- i. preparing a first APO-I-preparation-mixture of vilazodone free base and a first APO-I-preparation-solvent, the first APO-I-preparation-solvent comprising benzyl alcohol;
- ii. treating the first APO-I-preparation mixture with hydrochloric acid;
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- iii. crystallizing the benzyl alcohol solvate of vilazodone hydrochloride.
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The A Form APO-II of vilazodone hydrochloride benzyl alcohol solvate characterized by a PXRD diffractogram comprising peaks, in terms of degrees 2-theta, at approximately 10.5, 13.3, 15.8, 19.5, 21.2 and 24.7.
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A process for preparation of Form APO-II of vilazodone hydrochloride benzyl alcohol solvate, the process comprising:
- i. preparing a first APO-II-preparation-mixture of vilazodone free base and a first APO-II-preparation-solvent, the first APO-II-preparation-solvent comprising benzyl alcohol;
- ii. treating the first APO-II-preparation-mixture with hydrochloric acid to produce a second APO-II-preparation-mixture;
- iii. heating the second APO-II-preparation-mixture to a temperature of from about 80° C. to about 100° C.;
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- iv. crystallizing the Form APO-II vilazodone hydrochloride benzyl alcohol solvate.
A process for preparation of Form APO-II of vilazodone hydrochloride benzyl alcohol solvate comprising heating a third APO-II-preparation-mixture comprising Form APO-I of vilazodone hydrochloride benzyl alcohol solvate and benzyl alcohol to a temperature of from about 80° C. to about 100° C.
Dependencies are inferred from the claim text.