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 .- 9 . (canceled)
10 . A modified release pharmaceutical composition comprising about 600 milligrams to about 1,000 milligrams of (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine.
11 . The modified release pharmaceutical composition of claim 10 , wherein the modified release composition releases the (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine over a 12 hour period.
12 . The modified release pharmaceutical composition of claim 10 , wherein the modified release composition releases the (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine over a 24 hour period.
13 . The modified release pharmaceutical composition of claim 10 , wherein the chiral purity for the (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine is 99.9% or greater.
14 . The modified release pharmaceutical composition of claim 10 , wherein the chiral purity for the (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine is 99.95% or greater.
15 . The modified release pharmaceutical composition of claim 10 , wherein the chiral purity for the (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine is 99.99% or greater.
16 . The modified release pharmaceutical composition of claim 10 , wherein the chiral purity for the (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine is 100%.
17 . The modified release pharmaceutical composition of claim 10 , further comprising a non-effective dose of (6S)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine.
18 . The modified release pharmaceutical composition of claim 17 , wherein the non-effective dose of (6S)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine does not exceed about 1.0 mg.
19 . The modified release pharmaceutical composition of claim 17 , wherein the non-effective dose of (6S)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine does not exceed about 0.75 mg.
20 . The modified release pharmaceutical composition of claim 17 , wherein the non-effective dose of (6S)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine does not exceed about 0.5 mg.
21 . The modified release pharmaceutical composition of claim 17 , wherein the non-effective dose of (6S)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine does not exceed about 0.25 mg.
22 . The modified release pharmaceutical composition of claim 17 , wherein the non-effective dose of (6S)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine does not exceed about 0.125 mg.
23 . The modified release pharmaceutical composition of claim 17 , wherein the non-effective dose of (6S)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine is less than about 0.125 mg.
24 . The modified release pharmaceutical composition of claim 10 , further comprising a pharmaceutically acceptable carrier.
25 . The modified release pharmaceutical composition of claim 10 , wherein the modified release pharmaceutical composition is suitable for oral administration.
26 . The modified release pharmaceutical composition of claim 10 , wherein the modified release pharmaceutical composition is a solid oral dosage form.
27 . The modified release pharmaceutical composition of claim 10 , wherein the modified release pharmaceutical composition is a capsule.
28 . The modified release pharmaceutical composition of claim 10 , wherein the modified release pharmaceutical composition is a tablet.
29 . The modified release pharmaceutical composition of claim 10 , wherein (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine is a hydrochloride salt.