SOLID PHARMACEUTICAL COMPOSITION COMPRISING 4-CYANO-TRIFLUORO-3-4-FLUOROPHENYL SULPHONYL-2-HYDROXY-2-METHYLPROPIONO- M TOLUIDIDE, PVP, AN ANTI-OESTROGEN AND/OR AN AROMATASE INHIBITOR

摘要

The present invention relates to a pharmaceutical formulation comprising the drug 4'−cyano−&agr;',&agr;',&agr;&ap os;−trifluoro−3−(4−fluorophenylsulphonyl& rpar;−2−hydroxy−2−methylpropiono−m−toluidide in a solid dispersion with PVP, the formulation further comprising an anti−oestrogen (eg, tamoxifen citrate) and/or an aromatase inhibitor (eg, anastrozole). The invention also relates to a pharmaceutical dose of the drug and anti−oestrogen/aromatase inhibitor provided by such a formulation. An advantage is the treating and/or preventing of at least one side effect selected from gynaecomastia, breast tenderness, hot flushes, impotence and reduction in libido, while increasing the bioavailability of the drug; reducing inter−patient variability in plasma concentrations of the 4'−cyano−&agr;',&agr;',&agr;&ap os;−trifluoro−3−(4−fluorophenylsulphonyl& rpar;−2−hydroxy−2−methylpropiono−m−toluidide; enhancing the storage stability of the drug; and/or treating and/or reducing the risk of prostate cancer in a patient.