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 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 .