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