A new extended release oral dosage form

Details A new extended release oral dosage form A new extended release oral dosage form

A - Human Necessities

61

K

A61K 9/22 (2006.01) A61K 9/20 (2006.01) A61K 31/353 (2006.01) A61P 25/00 (2006.01) A61P 25/04 (2006.01) A61K 9/28 (2006.01)

Patent

CA 2457339

The present invention relates to an extended release oral dosage form of a pharmaceutically active substance, (R)-3-N,N-dicyclobutylamino-8-fluoro-3,4- dihydro-2H-1-benzopyran-5-carboxamide, in the form of the free base or pharmaceutically acceptable salts and/or hydrates or solvates thereof. Furthermore, the invention relates to an extended release oral dosage form that provides a defined blood concentration profile having no rapid initial rise in blood plasma concentration of said active substance when administered at low dose. The invention further relates to processes for preparing said dosage form, the use of said dosage form and a method of prevention and/or treatment of CNS disorders and related medical disturbances using said dosage form.

La présente invention concerne une forme posologique orale à libération prolongée d'une substance pharmaceutiquement active, <i>(R)</i>-3-<i>N,N</i>-dicyclobutylamino-8-fluoro-3,4-dihydro-2<i>H</i>-1-benzopyran-5-carboxamide, se présentant sous la forme d'une base libre ou leurs sels pharmaceutiquement tolérables et/ou leurs hydrates ou solvates. L'invention concerne également une forme posologique orale à libération prolongée qui donne un profil de concentration sanguine dépourvu d'augmentation initiale rapide de la concentration du plasma sanguin de la substance active lorsqu'elle est administrée à faible dose. L'invention concerne enfin des procédés de préparation de cette forme posologique, son utilisation et un procédé de prévention et/ou de traitement de troubles du système nerveux central et des perturbations médicales associées à l'aide de cette forme posologique.

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