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AssigneeShasun Pharmaceuticals Limited
InventorsVijayabaskar Veerappan, Srimurugan Sankareswaran, Sathish Kumar Raman Viswanathan, N. Subramanian
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The present invention relates to a novel salt of (3aR,4S,7R,7aS)-2-[((1R,2R)-2-{[4-(1,2-benzisothiazol-3-yl)-piperazin-1-yl]methyl}cyclohexyl)methyl]hexahydro-1H-4,7-methanisoindol-1,3-dione and hydrates thereof, to methods for preparing the novel salt and its hydrates. In one aspect, the present invention provides a compound which is lurasidone dihydrochloride. In another aspect, the present invention provides a process for preparation of lurasidone dihydrochloride comprising: (i) mixing lurasidone free base in an organic solvent system; (ii) subjecting step (i) mixture to acid proton source; and (iii) isolating compound of lurasidone dihydrochloride.
A compound of formula-I
A compound according to any one of claims 5 to 8, having a differential scanning calorimetry thermogram substantially as shown in FIG. 2.
A compound according to any one of claims 5 to 9, having a thermo gravimetric analysis thermogram substantially as shown in FIG. 3.
A process for preparation of compound I comprising:
A process according to claim 11, wherein said acid proton source comprises of concentrated hydrochloric acid or dry gas.
A process according to claim 12, wherein said acid proton source either be dissolved in organic solvent or passed as dry gas.
A process according to claim 13, wherein said organic solvent system used in step (i) selected from A group comprising ketone, nitrile, ether, ester, chlorinated solvents or mixtures thereof.
A process according to claim 14, wherein said organic solvent comprises of acetone, acetonitrile, ethyl acetate, ether, dichloromethane or mixtures thereof.
A process for preparing Lurasidone dihydrochloride comprising:
Dependencies are inferred from the claim text.