摘要 |
<p>Orally administrable modified release pharmaceutical composition comprising pellets which comprise: (a) an inert core: (b) a first layer comprising a therapeutic agent, such as an amphetamine, and a hydrophilic binder: and (c) a modified enteric coating comprising an enteric polymer and a channeling agent, wherein said composition provides a continuous release of the therapeutic agent at a pH of less than 5.5, and a pulsatile release of the therapeutic agent at a pH of 6 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 pharmaceutical composition is also disclosed.</p> |