Prolonged-release pharmaceutical composition for oral administration of sultiame

A prolonged-release pharmaceutical composition for oral administration of sultiame in the form of particles, wherein the particles have a maximal particle size of at most 3000 μm and comprise:

• a core, having a particle size ranging from 600 μm to 1000 μm, which is devoid of sultiame,
• a first layer surrounding the core, which comprises sultiame, and
• an outer layer surrounding said first layer and providing prolonged-release of sultiame, the amount of sultiame being from 0.5 mg to 5.0 mg per particle,
• and wherein, when orally administered in one daily dose of 200 mg to healthy adult subjects under fasting conditions, the prolonged-release pharmaceutical composition provides a pharmacokinetic profile for sultiame having the following features:
• (i) a median Tmax of at least 36 hours;
• (ii) a mean Cmax of less than 0.3 μg/mL;
• and
• (iii) a mean AUC0-t of less than 22 h*μg/mL.