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Claims for Patent: 6,635,284

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Claims for Patent: 6,635,284

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: Celegene Corporation (Warren, NJ)
Application Number:09/038,470
Patent Claims: 1. A method for treating disease amenable to treatment with a phenidate drug in a patient in need of such treatment comprising administering to the patient a dosage form providing once-daily oral administration of d-threo-methylphenidate hydrochloride, said dosage form comprising two groups of particles, each containing d-threo-methylphenidate, wherein: a) said first group of particles comprises from about 2% to about 99% by weight of d-threo-methylphenidate hydrochloride and provides a substantially immediate dose of said d-threo methylphenidate upon ingestion by a mammal; and b) said second group of particles comprises coated particles, said coated particles comprising from about 2% to about 75% by weight of d-threo-methylphenidate in admixture with one or more binders, and a coating consisting of an ammonio methacrylate copolymer in an amount sufficient to provide a dose of said d-threo-methylphenidate hydrochloride delayed by from about 2 hours to about 7 hours following said ingestion.

2. A dosage form of a pharmaceutically acceptable salt of a methylphenidate providing an in vivo plasma concentration of said methylphenidate comprising two maxima, wherein said maxima are temporally separated by from about two hours to about seven hours and wherein the magnitude of said maxima differ by no more than about 30%.

3. A method for treating disease amenable to treatment with a phenidate drug in a patient in need of such treatment comprising administering to the patient a dosage form providing once-daily oral administration of the phenidate drug, said dosage form comprising two groups of particles, each containing the drug wherein: a) said first group of particles comprises from about 2% to about 99% by weight of the phenidate drug and provides a substantially immediate dose of said phenidate drug upon ingestion by a mammal; and b) said second group of particles comprises coated particles, said coated particles comprising from about 2% to about 75% by weight of the phenidate drug in admixture with one or more binders, and a coating consisting of an ammonio methacrylate copolymer in an amount sufficient to provide a dose of said phenidate drug delayed by from about 2 hours to about 7 hours following said ingestion.

4. The method of claim 3 wherein said delay is at least about 3 hours.

5. The method of claim 3 wherein said delay is at least about 4 hours.

6. The method of claim 1 wherein said delay is at least about 3 hours.

7. The method of claim 1 wherein said delay is at least about 4 hours.

8. The dosage form of claim 2 wherein the temporal separation is at least about 3 hours.

9. The dosage form of claim 2 wherein the temporal separation is at least about 4 hours.

10. A method for treating disease amenable to treatment with a phenidate drug in a patient in need of such treatment comprising administering to the patient a dosage form of a pharmaceutically acceptable salt of d-threo-methylphenidate, said dosage form providing an in vitro release profile comprising two pulses of drug release, wherein said pulses are temporally separated by from about 2 hours to about 7 hours.

11. A method for treating disease amenable to treatment with a phenidate, drug in a patient in need of such treatment comprising administering to the patient a dosage form of a pharmaceutically acceptable salt of d-threo-methylphenidate providing an in vivo plasma concentration of said d-threo-methylphenidate comprising two maxima, wherein said maxima are temporally separated by from about 2 hours to about 7 hours, and wherein the magnitude of said maxima differ by no more than about 30 percent.
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