Extended-release topiramate capsules

摘要

An extended-release topiramate capsule that includes a capsule shell containing a single population of coated particles; wherein each coated particle includes a core and a coating thereon; wherein each particle core includes a homogeneous mixture comprising topiramate throughout its core; and wherein the coating includes one or more release controlling agent(s).

主权项

1. An extended-release topiramate capsule comprising:
a capsule shell comprising a single population of coated particles;
wherein each coated particle comprises a core and a coating thereon;wherein each particle core comprises a homogeneous mixture throughout its core, the mixture comprising:
40 wt-% to 50 wt-% of topiramate, based on the total weight of an uncoated particle core;45 wt-% to 55 wt-% of one or more filler(s), based on the total weight of an uncoated particle core; and3 wt-% to 7 wt-% of one or more binder(s), based on the total weight of an uncoated particle core;wherein the coating comprises components including:
one or more release controlling agent(s);one or more pore former(s); andone or more plasticizer(s);wherein the coating components are present in amounts that provide an extended release topiramate capsule; wherein, when a single dose is given to a healthy human subject, an AUC0-inf of 170 to 210 h·μg/mL within a 95% confidence interval, and a Cmax of 2 to 4 μg/mL within a 95% confidence interval are achieved in the subject's plasma.