Sublingual apomorphine

Abstract

The invention features sublingual formulations of apomorphine and apomorphine prodrugs, and methods of treating Parkinson's disease, sexual dysfunction, and depressive disorders therewith.

What is claimed is: 
     
         1 - 2 . (canceled) 
     
     
         3 . A method of treating sexual dysfunction in a subject afflicted with sexual dysfunction, said method comprising administering to said subject a pharmaceutical composition in unit dosage form formulated for sublingual administration, wherein said unit dosage form is a film having a first portion comprising apomorphine particles comprising an acid addition salt of apomorphine and a second portion comprising a pH neutralizing agent. 
     
     
         4 . The method of  claim 3 , wherein said acid addition salt of apomorphine is apomorphine hydrochloride. 
     
     
         5 . The method of  claim 3 , wherein said first portion is a first layer that is acidic and said second portion is a second layer. 
     
     
         6 . The method of  claim 3 , wherein said unit dosage form further comprises a barrier separating said first portion from said second portion. 
     
     
         7 . The method of  claim 6 , wherein said first portion is a first layer that is acidic, said second portion is a second layer, and said barrier is a film separating the first layer and the second layer. 
     
     
         8 . A method of treating a depressive disorder in a subject afflicted with the depressive disorder, said method comprising administering to said subject a pharmaceutical composition in unit dosage form formulated for sublingual administration, wherein said unit dosage form is a film having a first portion comprising apomorphine particles comprising an acid addition salt of apomorphine and a second portion comprising a pH neutralizing agent. 
     
     
         9 . The method of  claim 8 , wherein said acid addition salt of apomorphine is apomorphine hydrochloride. 
     
     
         10 . The method of  claim 9 , wherein said first portion is a first layer that is acidic and said second portion is a second layer. 
     
     
         11 . The method of  claim 10 , wherein said unit dosage form further comprises a barrier separating said first portion from said second portion. 
     
     
         12 . The method of  claim 11 , wherein said first portion is a first layer that is acidic, said second portion is a second layer, and said barrier is a film separating the first layer and the second layer. 
     
     
         13 . A pharmaceutical composition in unit dosage form formulated for sublingual administration, wherein said unit dosage form has a first portion comprising apomorphine particles comprising an acid addition salt of apomorphine, a second portion comprising a pH neutralizing agent, and a barrier separating said first portion from said second portion. 
     
     
         14 . The pharmaceutical composition of  claim 13 , wherein said acid addition salt of apomorphine is apomorphine hydrochloride. 
     
     
         15 . The pharmaceutical composition of  claim 13 , wherein said first portion is a first layer that is acidic and said second portion is a second layer. 
     
     
         16 . The pharmaceutical composition of  claim 13 , wherein said barrier is a film or a coating separating the first portion and the second portion. 
     
     
         17 . A method of treating Parkinson's disease, dyskinesia, or akinesia in a subject afflicted with Parkinson's Disease, said method comprising administering to said subject the pharmaceutical composition of  claim 13 . 
     
     
         18 . A pharmaceutical composition in unit dosage form formulated for sublingual administration, wherein said unit dosage form is a sublingual gel comprising apomorphine particles comprising an acid addition salt of apomorphine or apomorphine prodrug, carboxymethylcellulose, and a pH neutralizing agent. 
     
     
         19 . The pharmaceutical composition of  claim 18 , wherein said sublingual gel comprises an acid addition salt of apomorphine. 
     
     
         20 . A method of treating Parkinson's disease, dyskinesia, or akinesia in a subject afflicted with Parkinson's Disease, said method comprising administering to said subject the pharmaceutical composition of  claim 18 . 
     
     
         21 . A pharmaceutical composition in unit dosage form formulated for sublingual administration, wherein said unit dosage form is a sublingual tablet comprising having a first portion comprising an acid addition salt of apomorphine, or an apomorphine prodrug, and a second portion comprising a pH neutralizing agent.