US2013230569A1PendingUtilityA1

Compositions of r(+) and s(-) pramipexole and methods of using the same

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Assignee: KNOPP NEUROSCIENCES INCPriority: May 16, 2006Filed: Apr 12, 2013Published: Sep 5, 2013
Est. expiryMay 16, 2026(expired)· nominal 20-yr term from priority
Inventors:Michael E. BozikThomas Petzinger, Jr.Valentin Gribkoff
A61P 43/00A61P 39/06A61P 25/16A61P 25/28A61K 9/0053A61K 9/0014A61K 9/4866A61K 31/428A61K 9/06A61K 9/20
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Claims

Abstract

Compositions of predetermined amounts of R(+) pramipexole and S(−) pramipexole and methods of using the same, including for the treatment and prevention of Parkinson's disease, are provided.

Claims

exact text as granted — not AI-modified
1 . A pharmaceutical composition comprising 100 milligrams to about 3,000 milligrams of R(+) pramipexole, about 0.125 mg to about 1.5 milligrams of S(−) pramipexole and a pharmaceutically acceptable carrier. 
     
     
         2 . The pharmaceutical composition of  claim 1 , wherein said R(+) pramipexole is from about 300 milligrams to about 1,500 milligrams. 
     
     
         3 . The pharmaceutical composition of  claim 1 , wherein said R(+) pramipexole is from about 500 milligrams to about 1,000 milligrams. 
     
     
         4 . The pharmaceutical composition of  claim 1 , wherein said pharmaceutical composition has a chiral purity for the R(+) enantiomer of pramipexole of 99% or greater. 
     
     
         5 . The pharmaceutical composition of  claim 1 , wherein said S(−) pramipexole is 0.125 milligrams 
     
     
         6 . The pharmaceutical composition of  claim 1 , wherein said S(−) pramipexole is 0.25 milligrams. 
     
     
         7 . The pharmaceutical composition of  claim 1 , wherein said S(−) pramipexole is 0.5 milligrams 
     
     
         8 . The pharmaceutical composition of  claim 1 , wherein said S(−) pramipexole is 1.0 milligrams. 
     
     
         9 . The pharmaceutical composition of  claim 1 , wherein said S(−) pramipexole is 1.5 milligrams. 
     
     
         10 . The pharmaceutical composition of  claim 1 , wherein said R(+) pramipexole is a pharmaceutically acceptable salt thereof. 
     
     
         11 . The pharmaceutical composition of  claim 10 , wherein said pharmaceutically acceptable salt is dihydrochloride. 
     
     
         12 . The pharmaceutical composition of  claim 1 , wherein said S(−) pramipexole is a pharmaceutically acceptable salt thereof. 
     
     
         13 . The pharmaceutical composition of  claim 12 , wherein said pharmaceutically acceptable salt is dihydrochloride. 
     
     
         14 . The pharmaceutical composition of  claim 1 , wherein pharmaceutical composition is selected from a tablet, a capsule, a cachet, a pellet, a pill, a powder, a granule, a liquid, a solution, an emulsion, a suspension, a semi-solid, an ointment, a paste, a cream, a gel, a jelly, a foam, a flash-melt, a lozenge, an aerosol, a suppository, an enema, and a patch. 
     
     
         15 . The pharmaceutical composition of  claim 1 , wherein pharmaceutical composition is selected from a tablet, a capsule and a liquid. 
     
     
         16 . The pharmaceutical composition of  claim 1 , wherein said pharmaceutical composition is suitable for administration selected from enteral administration and parenteral administration. 
     
     
         17 . The pharmaceutical composition of  claim 1 , wherein said pharmaceutical composition is suitable for administration selected from intranasal administration, intravascular administration, subcutaneous administration, intramuscular administration, intraperitoneal administration, transdermal administration, buccal administration, ocular administration, vaginal administration, rectal administration, inhaled administration, sublingual administration, topical administration and oral administration. 
     
     
         18 . The pharmaceutical composition of  claim 1 , wherein said pharmaceutical composition is immediate release. 
     
     
         19 . The pharmaceutical composition of  claim 1  further comprising an enteric coating. 
     
     
         20 . A pharmaceutical composition comprising 100 milligrams to about 3,000 milligrams of R(+) pramipexole, about 4.5 milligrams of S(−) pramipexole and a pharmaceutically acceptable carrier. 
     
     
         21 . The pharmaceutical composition of  claim 20 , wherein said R(+) pramipexole is from about 300 milligrams to about 1,500 milligrams. 
     
     
         22 . The pharmaceutical composition of  claim 20 , wherein said R(+) pramipexole is from about 500 milligrams to about 1,000 milligrams. 
     
     
         23 . The pharmaceutical composition of  claim 20 , wherein said pharmaceutical composition has a chiral purity for the R(+) enantiomer of pramipexole of 99% or greater. 
     
     
         24 . The pharmaceutical composition of  claim 20 , wherein said S(−) pramipexole is 4.5 milligrams 
     
     
         25 . The pharmaceutical composition of  claim 20 , wherein said R(+) pramipexole is a pharmaceutically acceptable salt thereof. 
     
     
         26 . The pharmaceutical composition of  claim 25 , wherein said pharmaceutically acceptable salt is dihydrochloride. 
     
     
         27 . The pharmaceutical composition of  claim 20 , wherein said S(−) pramipexole is a pharmaceutically acceptable salt thereof. 
     
     
         28 . The pharmaceutical composition of  claim 27 , wherein said pharmaceutically acceptable salt is dihydrochloride. 
     
     
         29 . The pharmaceutical composition of  claim 20 , wherein pharmaceutical composition is selected from a tablet, a capsule, a cachet, a pellet, a pill, a powder, a granule, a liquid, a solution, an emulsion, a suspension, a semi-solid, an ointment, a paste, a cream, a gel, a jelly, a foam, a flash-melt, a lozenge, an aerosol, a suppository, an enema, and a patch. 
     
     
         30 . The pharmaceutical composition of  claim 20 , wherein pharmaceutical composition is selected from a tablet, a capsule and a liquid. 
     
     
         31 . The pharmaceutical composition of  claim 20 , wherein said pharmaceutical composition is suitable for administration selected from enteral administration and parenteral administration. 
     
     
         32 . The pharmaceutical composition of  claim 20 , wherein said pharmaceutical composition is suitable for administration selected from intranasal administration, intravascular administration, subcutaneous administration, intramuscular administration, intraperitoneal administration, transdermal administration, buccal administration, ocular administration, vaginal administration, rectal administration, inhaled administration, sublingual administration, topical administration and oral administration. 
     
     
         33 . The pharmaceutical composition of  claim 20 , wherein said pharmaceutical composition is sustained release. 
     
     
         34 . The pharmaceutical composition of  claim 20  further comprising an enteric coating.

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