Sustained-release formulations of topiramate

摘要

Pharmaceutical compositions of topiramate for once-a-day oral administration are provided. The formulations comprise a sustained-release component and an optional immediate-release component, the compositions of which can be selectively adjusted, respectively, to release the active ingredient along a pre-determined release profile. Method of treating or preventing pathological disorders in mammalian subjects comprising the administration of the novel formulations disclosed herein is also provided.

主权项

1. A method of treatment of a neurological and/or psychiatric condition in a mammalian subject, comprising orally administering to said subject in need thereof a therapeutically effective amount of a sustained release formulation of 2,3:4,5-Di-O-isopropylidene-beta-D-fructopyranose sulfamate (topiramate), wherein all of the topiramate is released in a continuous manner from the formulation, wherein at least 85% by weight of the total topiramate in the formulation is contained in an extended release (XR) component comprising at least two populations of beads coated with a release controlling coating and each having its own rate of release, and wherein at least one of the at least two XR populations releases 80% of the topiramate contained therein in vitro in not more than 4 hours.