Production method of pharmaceutical composition containing active substance ziprasidone or its pharmaceutically admitted salt, increasing solubility and bio-availability of this drug, pharmaceutical composition and application of hydrophilic auxiliary subs

摘要

The present invention discloses a method for obtaining a pharmaceutical composition comprising an active agent ziprasidone or a pharmaceutically acceptable salt thereof, to improve solubility and thus bioavailability of the drug, whereby the active agent is slugged together with one or more pharmaceutically acceptable excipients. In preferred embodiment the active agent is slugged with solubilizing agent and optionally with additional diluent and/or lubricant. Preferably ziprasidone hydrochloride or ziprasidone hydrochloride monohydrate are used as the active agent. Preferably a hydrophilic excipient chosen from alkyl cellulose derivatives, starch derivatives, poly(oxy)ethylene derivatives, polyvinyl derivatives or glyceryl derivatives is used as the solubilizing agent. Preferably after slugging the active agent is further processed into a pharmaceutical composition In preferred embodiment the pharmaceutical composition is a solid dosage form, preferably an oral dosage form of a drug, preferably a capsule. A pharmaceutical composition which is producible according to the inventive method is also provided. In further aspect use of hydrophilic excipients for increasing solubility of ziprasidone or its pharmaceutically active salt is provided.