Patent ID: 7083808

Claim:
An oral dosage form comprising an effective amount of methylphenidate or a pharmaceutically acceptable salt thereof, wherein a portion of the methylphenidate or pharmaceutically acceptable salt thereof is in immediate release form and a portion of the methylphenidate or pharmaceutically acceptable salt thereof is in controlled release form, the controlled release form comprising a substrate comprising about 60% to about 70% of the methylphenidate or a pharmaceutically acceptable salt thereof and at least one pH dependent release modifying coating, wherein the pH dependent release modifying coating is applied to obtain a weight gain from about 2 to about 25% of the substrate, the formulation providing a time to maximum plasma concentration at about 0.5 to about 4 hours after oral administration, a peak plasma concentration from about 3 ng/ml to about 6.5 ng/ml per 20 mg dose of methylphenidate contained in the oral dosage form, wherein the peak concentration is from about 1.0 to about 2.0 times the plasma concentration of methylphenidate provided by the formulation at about 9 hours after oral administration, wherein the formulation provides an in-vitro dissolution as follows: Time % Methylphenidate (hours) HCl dissolved 0.25 0–45% 1 5–50% 4 40–90% 8 NLT 60% 12 NLT 80% and wherein the duration of effect provided by the methylphenidate contained in the formulation falls below effective plasma concentrations at about 8 to about 12 hours after oral administration, wherein about 30% to about 40% of the methylphenidate or pharmaceutically acceptable salt thereof is in immediate release form.