Compositions and methods for treatment of symptoms in parkinson's disease patients

Abstract

The invention provides dosage forms and methods utilizing nicotine to treat symptoms of a neurologic disorder. In some embodiments, the invention provides compositions for treatment of gait and balance problems associated with Parkinson's Disease.

1 .- 50 . (canceled) 
     
     
         51 . A delayed release dosage form for once-daily administration, said form comprising an effective amount of nicotine for treatment of symptoms of Parkinson's Disease or symptoms associated with dopaminergic treatment of Parkinson's,
 wherein the dosage form comprises a pH-dependent delayed release of the nicotine;   wherein said dosage form dispenses the nicotine in a metered fashion when the pH is above at least 5.0.   
     
     
         52 . The dosage form according to  claim 51 , wherein said dosage form dispenses the nicotine in a metered fashion when the pH is above at least 6.0. 
     
     
         53 . The dosage form according to  claim 51 , wherein said dosage form dispenses the nicotine in a metered fashion when the pH is above at least 7.0. 
     
     
         54 . The dosage form according to  claim 51 , wherein the dosage form comprises an enteric coating that effects the pH-dependent delayed release of the nicotine. 
     
     
         55 . The dosage form according to  claim 51 , wherein the dosage form further comprises a pH-independent extended release of the nicotine. 
     
     
         56 . The dosage form according to  claim 54 , wherein the dosage form comprises a pore former that effects the pH-independent extended release of the nicotine. 
     
     
         57 . The dosage form of  claim 51 , wherein the dosage form is a tablet. 
     
     
         58 . The dosage form according to  claim 51 , wherein the dosage form is configured to reduce gait and balance problems. 
     
     
         59 . The dosage form according to  claim 51 , wherein the dosage form is configured to reduce levodopa-induced dyskinesias. 
     
     
         60 . The dosage form according to  claim 51 , wherein nicotine is present at less than 10 mg. 
     
     
         61 . The dosage form according to  claim 51 , wherein about 1-2 mg nicotine is released in a first release, and about 2-3 mg nicotine is released in a second release. 
     
     
         62 . The dosage form of  claim 60 , wherein said dosage form is capable of being administered so that one or more metabolites of said nicotine achieves a plasma level of about 1 to about 500 ng/ml within four hours of administration. 
     
     
         63 . The dosage form according to  claim 51 , wherein said dosage form further comprises levodopa, carbidopa, or a combination thereof. 
     
     
         64 . The dosage form according to  claim 51 , wherein nicotine is present at about 10 mg. 
     
     
         65 . A method of treating gait and balance problems in a subject, comprising administering an oral composition comprising nicotine at a daily dose of about or at least 24 mg, wherein the gait and balance problems are direct symptoms of Parkinson's Disease. 
     
     
         66 . The method of  claim 65 , wherein the daily dose is about 12 mg. 
     
     
         67 . The method of  claim 65 , wherein nicotine is present is about 18 mg. 
     
     
         68 . The method of  claim 65 , wherein about 1-2 mg nicotine is released in a first release, and about 2-3 mg of nicotine is released in a second release. 
     
     
         69 . The method of  claim 65 , wherein said dosage form is capable of being administered so that one or more metabolites of said nicotine achieves a plasma level of about 1 to about 500 ng/ml within four hours of administration. 
     
     
         70 . The method of  claim 65 , wherein said dosage form is capable of being administered so that one or more metabolites of said nicotine achieves an efficacious plasma level within about one hour of administration and further achieves a maximum plasma level peak from two to twelve hours from administration.