Salts and hydrates of antipsychotics
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.
1. A compound of Formula-I
2. The compound according to claim 1 , wherein said compound is crystalline.
3. The compound according to claim 1 , wherein said compound is a hydrate.
4. The compound of claim 3 , wherein said hydrate is dihydrate.
5. The compound according to claim 4 having an X-ray diffraction pattern comprising peaks at 4.4±0.2, 12.6±0.2, 13.9±0.2, 26.2±0.2, 20.9±0.2 and 17.2±0.2 degrees 2θ.