Controlled/modified release oral methylphenidate formulations
AssigneeEuro-Celtique S.A.
InventorsPaul D. Goldenheim, Richard S. Sackler, Thinnayam N. Krishnamurthy, Andrew Darke, Benjamin Oshlack
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Abstract
The invention is directed to oral modified/controlled release methylphenidate formulations which provide a rapid initial onset of effect and a prolonged duration of effect. Preferably, the peak concentration is lower than that provided by the reference standard for immediate release methylphenidate formulations, and the duration of effect falls rapidly at the end of the dosing interval so as not to affect the appetite of the patient at dinner nor the patient's sleep thereafter.
Claims5
An oral dosage form comprising an effective amount of methylphenidate or a pharmaceutically acceptable salt thereof and at least one release modifying material which causes the formulation to provide an in-vitro dissolution of the drug of from about 0 to about 45% released after 0.25 hour;
- from about 10 to about 50% released after about 1 hour;
- from about 30 to about 80% drug released after about 4 hours;
- not less than about 65% drug released after 8 hours;
- and not less than about 80% of the drug released after about 12 hours;
- the oral dosage form when orally administered to a human patient further providing a time to maximum plasma concentration at about 0.5 to about 2 hours after oral administration, and a duration of effect which lasts from about 8 to about 10 hours after oral administration, wherein the plasma concentration of the drug rapidly falls at about 8 to about 10 hours after oral administration to a level which is below the minimum effective plasma concentration.
Dependencies are inferred from the claim text.