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 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 and a second portion comprising a pH neutralizing agent, wherein the unit dosage form comprises a polymer selected from the group consisting of carboxymethylcellulose; cellulose acetate; ethylcellulose; hydroxyethylcellulose; hydroxypropylmethylcellulose; nitrocellulose; polyoxyethylene/polyoxypropylene polymers, copolymers or block copolymers; gums; and combinations thereof. 
     
     
         4 . The pharmaceutical composition of  claim 3 , wherein said polymer comprises carboxymethylcellulose, cellulose acetate, ethylcellulose, hydroxyethylcellulose, or hydroxypropylmethylcellulose. 
     
     
         5 . The pharmaceutical composition of  claim 3 , wherein said unit dosage form is a lozenge, a pill, a tablet, a film, or a strip. 
     
     
         6 . The pharmaceutical composition of  claim 3 , further comprising an antioxidant. 
     
     
         7 . The pharmaceutical composition of  claim 3 , further comprising a permeation enhancer. 
     
     
         8 . The pharmaceutical composition of  claim 3 , further comprising glycerol monostearate. 
     
     
         9 . The pharmaceutical composition of  claim 3 , wherein said pH neutralizing agent is an organic base. 
     
     
         10 . The pharmaceutical composition of  claim 3 , wherein said first portion comprises apomorphine particles having an effective particle size of from about 1 μm to about 10 μm. 
     
     
         11 . The pharmaceutical composition of  claim 3 , wherein said acid addition salt of apomorphine is apomorphine hydrochloride. 
     
     
         12 . The pharmaceutical composition of  claim 3 , wherein said unit dosage form comprises from 2 to 40 mg of the acid addition salt of apomorphine. 
     
     
         13 . A method of treating Parkinson's disease, dyskinesia, or akinesia in a mammal afflicted with Parkinson's Disease, said method comprising administering to said mammal the pharmaceutical composition of  claim 3 . 
     
     
         14 . A method of treating an “off” episode in a subject suffering from Parkinson's disease, said method comprising administering to said patient the pharmaceutical composition of  claim 3 . 
     
     
         15 . A method of treating sexual dysfunction in a mammal afflicted with sexual dysfunction, said method comprising administering to said mammal the pharmaceutical composition of  claim 3 .