US2014031401A1PendingUtilityA1

Modified Release Formulations of (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine and Methods of Using the Same

57
Assignee: KNOPP NEUROSCIENCES INCPriority: Dec 14, 2006Filed: Jul 16, 2013Published: Jan 30, 2014
Est. expiryDec 14, 2026(~0.4 yrs left)· nominal 20-yr term from priority
Inventors:Michael E. BozikThomas Petzinger, Jr.Valentin Gribkoff
A61K 31/428
57
PatentIndex Score
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Cited by
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References
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Claims

Abstract

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.

Claims

exact text as granted — not AI-modified
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.

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