An improved process for the preparation of lurasidone hydrochloride
AssigneeJubilant Generics Limited (Formerly Jubilant Life Sciences Division)
InventorsVaibhav MISHRA, Shailendr DUBEY, Kumber SINGH, Alka Srivastava CHOUDHARY, Dharam VIR
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Abstract
Disclosed herein is an improved process for the preparation of Lurasidone and its pharmaceutically acceptable salts via novel intermediate and use thereof for the preparation of an antipsychotic agent useful for the treatment of schizophrenia and bipolar disorder. Further, present invention provides a cost effective and eco-friendly process for producing Lurasidone hydrochloride of formula (I) substantially free of residual solvent(s) at industrial scale.
Claims10
A process for the preparation of lurasidone or a pharmaceutically acceptable salt thereof, comprising the steps of:
- a) converting ((R,R)-cyclohexane-1,2-diyl)bis((1H-imidazol-1-yl)methanone) to trans(R,R)-1,2-bis(hydroxymethyl)cyclohexane,
- b) converting trans(R,R)-1,2-bis(hydroxymethyl)cyclohexane obtained in step (a) to Lurasidone and
- c) optionally converting lurasidone free base into its pharmaceutically acceptable salt.
A compound of ((R,R)-cyclohexane-1,2-diyl)bis((1H-imidazol-1-yl)methanone) of formula (VI):
A process for the preparation of lurasidone hydrochloride substantially free of residual solvent (s) comprising the following steps:
- a) adding lurasidone free base to a water miscible solvent
- b) adding water to the mixture of step a);
- c) optionally heating the mixture of step b);
- d) adding alcoholic solution of hydrogen chloride;
- e) isolating lurasidone hydrochloride.
A process for the preparation of lurasidone hydrochloride substantially free of residual solvent (s) according to claim 9, the process comprising the following steps:
- a) adding lurasidone free base to acetone;
- b) adding water to the suspension of step (a);
- c) heating the mixture of step (b);
- d) adding isopropanolic solution of hydrogen chloride;
- and
- e) isolating lurasidone hydrochloride.
Lurasidone hydrochloride substantially free of residual solvent (s).
Dependencies are inferred from the claim text.