Claims
- 1. 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 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 plasma 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, 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.
- 2. The oral dosage form of claim 1, wherein the oral dosage form provides a time to maximum plasma concentration at about 0.5° to about 2 hours after oral administration.
- 3. The oral dosage form of claim 2, wherein the peak plasma concentration is from about 1.0 to about 1.7 times the plasma concentration of methylphenidate provided by the formulation at about 9 hours after oral administration.
- 4. The oral dosage form of claim 3, wherein the duration of effect provided by the methylphenidate contained in the oral dosage form falls below effective plasma concentrations at about 8 to about 10 hours after oral administration.
- 5. The oral dosage form of claim 1, which provides a “square wave” plasma profile as depicted by Formulation 1.
- 6. An oral dosage form of claim 1, which provides an in-vitro dissolution as follows:
- 7. An oral dosage form of claim 1, which provides an in-vitro dissolution as follows:
- 8. 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.
- 9. The oral dosage form of claim 8, which when orally administered provides a peak plasma concentration from about 4 ng/ml to about 6.5 ng/ml per 20 mg dose of methylphenidate contained in the oral dosage form.
- 10. The oral dosage form of claim 8, which when orally administered provides a peak plasma concentration from about 5 ng/ml to about 6.5 ng/ml per 20 mg dose of methylphenidate contained in the oral dosage form.
- 11. The oral dosage form of claim 8, wherein the peak plasma 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.
- 12. The oral dosage form of claim 8, wherein the peak plasma concentration is from about 1.0 to about 1.7 times the plasma concentration of methylphenidate provided by the formulation at about 9 hours after oral administration.
Parent Case Info
[0001] This application claims priority from U.S. Provisional Application No. 60/112,667, filed Dec. 17, 1998, the disclosure of which is hereby incorporated by reference.
Provisional Applications (1)
|
Number |
Date |
Country |
|
60112667 |
Dec 1998 |
US |
Continuations (1)
|
Number |
Date |
Country |
Parent |
09465158 |
Dec 1999 |
US |
Child |
10741081 |
Dec 2003 |
US |