Patent ID: 9289394
Filing Date: 2016-03-22
CPC Classification: A61K

Claim Text:
1. A solid, oral pharmaceutical composition comprising a plurality of particles, each comprising: a core comprising dextroamphetamine or a pharmaceutical salt thereof and at least one pharmaceutically acceptable excipient; a extended release layer enclosing the core; and a delayed release layer enclosing the extended release layer, wherein the formulation provides at least an 8 hour lag period during which the formulation releases no more than 10% of the total dextroamphetamine or a pharmaceutical salt thereof followed by an extended release period of 10-12 hours when the composition is placed in 700 ml aqueous solution of 0.1N HCl pH 1.1, for up to 2 hours followed by hours 2-6 in sodium phosphate buffer at pH 6.0; followed by hours 6-20 in sodium phosphate buffer, pH 7.2 at 37° C.±0.0.5° C., measured by the USP Apparatus I.