Claims
- 1. A sustained release dosage form adapted to release reboxetine at a uniform rate over a prolonged period of time.
- 2. The dosage form of claim 1 wherein the prolonged period of time is four hours or greater.
- 3. The dosage form of claim 1 wherein the uniform rate is at least about 0.2 mg/hr.
- 4. The dosage form of claim 1 wherein the sustained release dosage form has a T90 of at least about 8 hours.
- 5. The dosage form of claim 4 wherein release of reboxetine is achieved through one or more methods associated with the group of methods including osmotic methods, diffusion methods, dissolution methods and ion-exchange methods.
- 6. The dosage form of claim 1 wherein the sustained release dosage form is an osmotic composition comprising a reboxetine-containing component admixed with an osmotic agent within an internal compartment, said internal compartment defined by a semipermeable membrane through which reboxetine is delivered via a delivery orifice formed or formable in said semipermeable membrane.
- 7. The dosage form of claim 1 wherein the sustained release dosage form is an osmotic composition comprising a reboxetine-containing component and a swellable polymer component within an internal compartment defined by a semipermeable membrane through which reboxetine is delivered via a delivery orifice formed or formable in said semipermeable membrane.
- 8. The dosage form described in claim 7 wherein the reboxetine-containing component and the swellable polymer component within the internal compartment are configured as adjacent layers and the delivery orifice is formed through the semipermeable membrane at a location adjacent to the reboxetine-containing component.
- 9. The dosage form described in claim 7 comprising a barrier layer, the reboxetine-containing component and the swellable polymer component being separated by the barrier layer within the internal compartment and the delivery orifice being formed through the semipermeable membrane at a location adjacent to the reboxetine-containing core.
- 10. The dosage form described in claim 9 comprising an inner wall between the semipermeable membrane and the reboxetine-containing component, the barrier layer and the swellable polymer component, the delivery orifice being formed through the semipermeable membrane and the inner wall at a location adjacent to the reboxetine-containing core.
- 11. A method of treating a condition in a subject responsive to reboxetine, the method comprising orally administering to the subject a sustained release dosage form adapted to release reboxetine at a uniform rate over a prolonged period of time.
- 12. The method of claim 11 wherein the prolonged period of time is four hours or greater.
- 13. The method of claim 11 wherein the uniform rate is at least about 0.2 mg/hr.
- 14. The method of claim 11 wherein the sustained release dosage form has a T90 of at least about 8 hours.
- 15. The method of claim 11 wherein said dosage form is administered once a day.
- 16. The method of claim 15 wherein release of reboxetine is achieved through one or more methods associated with the group of methods including osmotic methods, diffusion methods, dissolution methods and ion-exchange methods.
- 17. A method of treating a condition in a subject responsive to reboxetine, the method comprising administering a reboxetine dose once per day in a sustained release dosage form that produces a therapeutically effective average steady-state plasma reboxetine concentration.
- 18. A method of treating a condition in a subject responsive to reboxetine, the method comprising orally administering a reboxetine dosage form that produces a steady-state peak plasma reboxetine concentration at a time at least 4 hours following dose administration.
- 19. A method of treating a condition in a subject responsive to reboxetine, the method comprising orally administering reboxetine in a dosage form to produce one peak plasma reboxetine concentration during each 24-hour period.
- 20. A method of treating a condition in a subject responsive to reboxetine, the method comprising orally administering reboxetine in a dosage form that provides steady-state Cmax/dose ratios of less than about 30 and more preferably less than about 25.
- 21. A dosage form adapted for sustained drug delivery over a prolonged period of time comprising reboxetine and a carbohydrate.
- 22. The dosage form of claim 21 wherein the carbohydrate is selected from the group consisting of maltodextrin, lactose, dextrose, sucrose, mannitol, and sorbitol.
- 23. The dosage form of claim 22 comprising reboxetine and maltodextrin having a dextrose equivalence (DE) of 20 or less.
- 24. The dosage of claim 23 wherein the maltodextrin has a dextrose equivalence (DE) of 9-20.
- 25. The dosage form of claim 21 formed as a tablet compressed under a force of 3500 newtons or greater.
- 26. A composition comprising reboxetine and maltodextrin.
- 27. The composition of claim 25 formed as a compressed composition under a force of 3500 newtons or greater.
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority under 35 USC 119(e) of U.S. Ser. No. 60/153997, filed Sep. 15, 1999, which is incorporated herein by reference.
Provisional Applications (1)
|
Number |
Date |
Country |
|
60153997 |
Sep 1999 |
US |
Continuations (1)
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Number |
Date |
Country |
Parent |
09661976 |
Sep 2000 |
US |
Child |
10087026 |
Feb 2002 |
US |