CA2758556A1 — Pharmaceutical composition of amphetamine mixed salts

USPTO Abstract

The present invention relates to an orally administrable modified release pharmaceutical composition comprising pellets containing one or more active ingredients, more specifically the present invention is directed to dosage form comprising one or more amphetamine salts, which comprising: (a) an inert core; (b) a first layer, said layer comprises at least one pharmaceutically active ingredient and at least one hydrophilic binder; and (c) a modified enteric coating, said modified enteric coating comprises an enteric polymer and a channeling agent, wherein said composition provides: a continuous release of the pharmaceutically active ingredient at pH less than 5.5, and a pulsatile release of the pharmaceutically active ingredient at pH 6.0 or more; and has an in vitro dissolution profile of at least 95% of the active ingredient dissolved within 4 hours after administration. A method of manufacturing the modified release pharmaceutical composition is also disclosed.