abstract |
Compositions comprising crystalline zioprasidone hydrochloride particles, having an average particle size of less than 85 micrometers, and a pharmaceutically acceptable carrier are substantially bioequivalent and can be used to treat psychoses, such as schizophrenia. A process for preparing large crystals of ziprasidone hydrochloride monohydrate, comprising the steps of: 1- dissolving ziprasidone free base in a solvent comprising THF and water, in a volume ratio of about 22-25 volume units of THF to about 1.5-8 units of volume of water; 2- heat the solution resulting from step (1) 3- add HCL to the solution resulting from step (2) 4- cool the solution resulting from step (3). |