SOLID PHARMACEUTICAL COMPOSITION COMPRISING 4 -CYANO-TRIFLUORO-3-(4-FLUOROPHENYLSULPHONYL)-2-HYDROXY-2-METHYLPROPIONO- M TOLUIDIDE AND PVP

摘要

The present invention relates to a pharmaceutical formulation comprising the drug 4'-cyano- alpha ', alpha ', alpha '-trifluoro-3-(4-fluorophenylsulphonyl)-2-hydroxy-2-methylpropiono-m-toluidide in a solid dispersion with PVP. In one embodiment, >50% of the drug is provided in the form of the R-enantiomer. The invention also relates to a daily pharmaceutical dose of the drug provided by such a formulation. In addition, the invention relates to the use of PVP in solid dispersion with the drug (in one embodiment wherein >50% of the 4'-cyano- alpha ', alpha ', alpha '-trifluoro-3-(4-fluorophenylsulphonyl)-2-hydroxy-2-methylpropiono-m-toluidide is provided in the form of the R-enantiomer) for increasing the bioavailability of the drug; for reducing inter-patient variability in plasmaconcentrations of the drug; for enhancing the storage stability of the drug; or for treating and/or reducing the risk of prostate cancer in a patient.