A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/14 (2006.01) A61K 31/275 (2006.01) A61P 35/00 (2006.01)
Patent
CA 2462219
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 an enteric polymer having a pKa from 3 to 6, wherein > 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 an enteric polymer having a pKa from 3 to 6 in solid dispersion with the drug, wherein > 50 % of the drug is provided in the form of the R-enantiomer, for increasing the bioavailability of the drug; for reducing inter-patient variability in plasma concentrations 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.
L'invention concerne une préparation pharmaceutique contenant le médicament 4'-cyano-.alpha.',.alpha.',.alpha.'-trifluoro-3-(4-fluorophénylsulfonyl)-2-hydroxy-2-méthylpropiono-m-toluidide dans une dispersion solide avec un polymère entérique présentant un pK¿a? compris entre 3 et 6, >50 % de ce médicament étant sous la forme de l'énantiomère R. L'invention concerne également une dose pharmaceutique quotidienne du médicament obtenu par ladite préparation. L'invention concerne encore l'utilisation d'un polymère entérique présentant un pK¿a? compris entre 3 et 6, en dispersion solide avec le médicament, >50 % de ce médicament étant sous la forme de l'énantiomère R, pour améliorer la biodisponibilité du médicament, réduire les variations entre les patients des concentrations de plasma du médicament, améliorer la stabilité de stockage du médicament ou traiter et/ou réduire le risque de cancer de la prostate chez un patient.
Bateman Nicola Frances
Cahill Julie Kay
Astrazeneca Uk Limited
Fetherstonhaugh & Co.
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