abstract |
Disclosed is crystalline duloxetine hydrochloride which is prepared by: (a) dissolving duloxetine in toluene to form a first solution; (b) combining the first solution with a second organic solvent comprising ethanol and HCI to form a second solution; (c) allowing duloxetine hydrochloride to crystallise out from the solution during a period of cooling at 0°C to 10°C; and (d) collecting the crystallised duloxetine hydrochloride, wherein said crystalline duloxetine hydrochloride exhibits an X-ray diffraction pattern comprising peaks expressed in degrees two-theta at 11.99 ± 0.2, 14.78 ± 0.2, 21.44 ± 0.2, 22.16 ± 0.2, 23.12 ± 0.2 and 24.12 ± 0.2. |