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|Title:||Delivery of multiple doses of medications|
|Abstract:||Dosage forms for oral administration of a methylphenidate drug are provided. The dosage forms provide a substantially immediate dose of methylphenidate upon ingestion, followed by one or more additional doses at predetermined times. By providing such a drug release profile, the dosage forms eliminate the need for a patient to carry an additional dose for ingestion during the day. The dosage forms and methods provided are useful in administering methylphenidate and pharmaceutically acceptable salts thereof, which generally require one or more doses throughout the day.|
|Inventor(s):||Mehta; Atul M. (Ramsey, NJ), Zeitlin; Andrew L. (Millington, NJ), Dariani; Maghsoud M. (Fanwood, NJ)|
|Assignee:||Celgene Corporation (Warren, NJ)|
1. A solid dosage form comprising d-threo methylphenidate or salt thereof providing a plasma concentration profile of said d-threo methylphenidate or salt thereof comprising two
maxima temporally separated by from about two hours to about seven hours, said solid dosage form comprising: (a) a first group of particles comprising from about 2% to about 99% by weight of d-threo methylphenidate or salt thereof; and (b) a second
group of particles comprising coated particles, said coated particles comprising from about 2% to about 75% by weight of d-threo methylphenidate or salt thereof in admixture with one or more binders and a coating comprising an ammonio methacrylate
2. The solid dosage form of claim 1, wherein said solid dosage form is a tablet.
3. The solid dosage form of claim 1, wherein said solid dosage form is a capsule.
4. The solid dosage form of claim 1, wherein the d-threo methylphenidate or salt thereof is d-threo methylphenidate hydrochloride.
5. The solid dosage form of claim 1, wherein the first group of particles provides a substantially immediate dose of said d-threo methylphenidate upon ingestion by a mammal.
6. The solid dosage form of claim 1, wherein the magnitude of said plasma concentration profile maxima differ by no more than about 30%.
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