A NEW EXTENDED RELEASE ORAL DOSAGE FORM

摘要

The present invention relates to a new extended release oral dosage form of the good soluble 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, for use in the prevention and/or treatment of central nervous system (CNS) disorders and related medical disturbances. More particularly, 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 the good soluble active substance when administered at low dose. The invention further relates to processes for preparing said dosage form, the use of said dosage and a method of prevention and/or treatment of CNS disorders and related medical disturbances using said dosage form.