CONTROLLED RELEASE DOPAMINE AGONIST COMPOSITIONS

1 . A multiphase release oral pharmaceutical formulation comprising: a first component comprising a dopamine agonist or a pharmaceutically acceptable salt thereof, and a second component comprising a dopamine agonist or a pharmaceutically acceptable salt thereof, wherein the first component provides an immediate release of the dopamine agonist or the pharmaceutically acceptable salt thereof following oral administration to a patient, and wherein the second component provides a modified release of the dopamine agonist or the pharmaceutically acceptable salt thereof following oral administration to a patient.

2 . The formulation of claim 1 , wherein the first components is one layer of a multi-layer tablet and the second component is another layer of the multi-layer tablet.

3 . The formulation of claim 1 , wherein the first components comprises immediate release beads and the second component comprises controlled-release beads.

4 . The formulation of claim 1 , wherein the first component and the second component are combined on a single group of controlled release beads.

5 . The formulation of claim 3 or 4 , wherein the beads are compressed into a tablet.

6 . The formulation of claim 3 or 4 , wherein the beads are contained in a capsule.

7 . The formulation of claim 1 , wherein the dopamine agonist is pramipexole of a pharmaceutically acceptable salt thereof.

8 . The formulation of claim 7 , wherein at least about 20% of the total pramipexole or pharmaceutically acceptable salt thereof is released from the formulation within the first hour as measured in an in vitro dissolution test.

9 . The formulation of claim 8 , wherein about 40% of the total pramipexole is released from the composition within the first two hours as measured in an in vitro dissolution test.

10 . A composition for the controlled release of a dopamine agonist comprising:

the dopamine agonist or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient, said composition providing an in vitro release profile wherein at least about 20% of the dopamine agonist is released within the first hour as measured in an in vitro dissolution test, and wherein said composition provides an in vivo absorption profile wherein the time to reach 40% absorption is less than about 3 hours on average after a single dose oral administration to a human adult.

11 . The composition of claim 10 , wherein the dopamine agonist is pramipexole or a pharmaceutically acceptable salt thereof.

12 . A method of treating a condition in a patient, comprising administering to the patient the formulation of claim 1 .

13 . The method of claim 12 , wherein the condition is selected from Parkinson's disease and restless leg syndrome.