Modified release formulations of (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine and methods of using the same
Modified release pharmaceutical compositions (controlled release, sustained release, and/or extended release) of the R-(+) enantiomer of pramipexole (RPPX) and methods of using such compositions for the treatment of neurodegenerative diseases, or those related to mitochondrial dysfunction or increased oxidative stress are disclosed.
1. A method of treating a chronic neurodegenerative disease selected from the group consisting of: Parkinson's disease and amyotrophic lateral sclerosis, in a patient in need thereof comprising administering a single unit dose of about 600 milligrams to about 1,000 milligrams of (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine in a modified release pharmaceutical composition wherein the modified release composition releases the (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine over a 24 hour period.
2. The method of claim 1 , wherein said patient is a naïve patient.
3. The method of claim 1 , wherein said chronic neurodegenerative disease is amyotrophic lateral sclerosis.
4. The method of claim 1 , wherein the chiral purity for the (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine is 99.9% or greater.
5. The method of claim 1 , wherein the chiral purity for the (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine is 99.95% or greater.
6. The method of claim 1 , wherein the chiral purity for the (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine is 99.99% or greater.
7. A method of treating a neurodegenerative disease selected from the group consisting of: Parkinson's disease and amyotrophic lateral sclerosis, in a patient in need thereof comprising administering to said patient a starting dose of about 600 milligrams to about 1,000 milligrams of (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine in a once daily modified release pharmaceutical composition wherein said patient is a naive patient and wherein the modified release composition releases the (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine over a 24 hour period.
8. The method of claim 7 , wherein said neurodegenerative disease is amyotrophic lateral sclerosis.
9. The method of claim 7 , wherein the chiral purity for the (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine is 99.9%, or greater.
10. The method of claim 7 , wherein the chiral purity for the (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine is 99.95%, or greater.
11. The method of claim 7 , wherein the chiral purity for the (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine is 99.99% or greater.