Compositions and methods of using (r)-pramipexole

Abstract

Pharmaceutical compositions of (R)-pramipexole and methods and kits of using such compositions for the treatment of neurodegenerative diseases, or those related to mitochondrial dysfunction or increased oxidative stress are disclosed.

What is claimed is: 
     
         1 . A method of treating a chronic disorder in a human patient in need thereof comprising orally administering once or twice per day to the human patient a single unit dose pharmaceutical composition comprising about 150 milligrams of R(+) Pramipexole, or pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier,
 wherein the R(+) Pramipexole, or pharmaceutically acceptable salt thereof, has a chiral purity of at least 99.7%,   wherein the administration occurs without dose-titration, and   wherein the chronic disorder is effectively treated with the single unit dose pharmaceutical composition.   
     
     
         2 . The method of  claim 1 , wherein the chronic disorder is a chronic neurodegenerative disease. 
     
     
         3 . The method of  claim 1 , wherein the human patient is a naïve patient. 
     
     
         4 . The method of  claim 2 , wherein the chronic neurodegenerative disease is selected from primary neurodegenerative disease, Huntington's Chorea, metabolically induced neurological damage, senile dementia of Alzheimer's type, age associated cognitive dysfunction, vascular dementia, multi-infarct dementia, Lewy body dementia, neurodegenerative dementia, neurodegenerative movement disorder, ataxia, Friedreich's ataxia, multiple sclerosis, spinal muscular atrophy, primary lateral sclerosis, seizure disorders, motor neuron disorder or disease, inflammatory demyelinating disorder, Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis, hepatic encephalopathy, and chronic encephalitis. 
     
     
         5 . The method of  claim 2 , wherein the chronic neurodegenerative disease is selected from neurodegenerative movement disorder, ataxia, seizure disorder, motor neuron disorder or disease, inflammatory demyelinating disorder, Alzheimer's disease, Parkinson's disease, and amyotrophic lateral sclerosis. 
     
     
         6 . The method of  claim 2 , wherein the chronic neurodegenerative disease is amyotrophic lateral sclerosis. 
     
     
         7 . The method of  claim 1 , wherein the chiral purity of the (R)-pramipexole, or a pharmaceutically acceptable salt thereof, is selected from at least 99.8%, at least 99.9%, at least 99.95% and at least 99.99%. 
     
     
         8 . The method of  claim 1 , wherein the single unit dose pharmaceutical composition is selected from a tablet and a capsule. 
     
     
         9 . The method of  claim 1 , wherein the single unit dose pharmaceutical composition is a solid, oral dosage form. 
     
     
         10 . The method of  claim 1 , wherein the pharmaceutically acceptable carrier is selected from microcrystalline cellulose, mannitol, croscarmellose sodium, magnesium stearate and any combinations thereof. 
     
     
         11 . A method of treating a chronic disorder in a human patient in need thereof comprising orally administering once or twice per day to the human patient a single unit dose pharmaceutical composition comprising a starting daily dose of about 150 milligrams of R(+) Pramipexole, or pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier,
 wherein the R(+) Pramipexole, or pharmaceutically acceptable salt thereof, has a chiral purity of at least 99.7%, and   wherein the chronic disorder is effectively treated with the single unit dose pharmaceutical composition.   
     
     
         12 . The method of  claim 11 , wherein the chronic disorder is a chronic neurodegenerative disease. 
     
     
         13 . The method of  claim 11 , wherein the human patient is a naïve patient. 
     
     
         14 . The method of  claim 12 , wherein the chronic neurodegenerative disease is selected from primary neurodegenerative disease, Huntington's Chorea, metabolically induced neurological damage, senile dementia of Alzheimer's type, age associated cognitive dysfunction, vascular dementia, multi-infarct dementia, Lewy body dementia, neurodegenerative dementia, neurodegenerative movement disorder, ataxia, Friedreich's ataxia, multiple sclerosis, spinal muscular atrophy, primary lateral sclerosis, seizure disorders, motor neuron disorder or disease, inflammatory demyelinating disorder, Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis, hepatic encephalopathy, and chronic encephalitis. 
     
     
         15 . The method of  claim 12 , wherein the chronic neurodegenerative disease is selected from neurodegenerative movement disorder, ataxia, seizure disorder, motor neuron disorder or disease, inflammatory demyelinating disorder, Alzheimer's disease, Parkinson's disease, and amyotrophic lateral sclerosis. 
     
     
         16 . The method of  claim 12 , wherein the chronic neurodegenerative disease is amyotrophic lateral sclerosis. 
     
     
         17 . The method of  claim 11 , wherein the chiral purity of the (R)-pramipexole, or a pharmaceutically acceptable salt thereof, is selected from at least 99.8%, at least 99.9%, at least 99.95% and at least 99.99%. 
     
     
         18 . The method of  claim 11 , wherein the single unit dose pharmaceutical composition is selected from a tablet and a capsule. 
     
     
         19 . The method of  claim 11 , wherein the single unit dose pharmaceutical composition is a solid, oral dosage form. 
     
     
         20 . The method of  claim 11 , wherein the pharmaceutically acceptable carrier is selected from microcrystalline cellulose, mannitol, croscarmellose sodium, magnesium stearate and any combinations thereof.