Sublingual apomorphine
Disclosed are sublingual formulations of apomorphine, and methods of treating Parkinson's disease therewith. The sublingual formulations are films or strips having a first portion comprising apomorphine particles comprising an acid addition salt of apomorphine and a second portion comprising a pH neutralizing agent.
1. A pharmaceutical composition in unit dosage form formulated for sublingual administration, wherein said unit dosage form is a film or a strip having a first portion comprising apomorphine particles comprising an acid addition salt of apomorphine and a second portion comprising a pH neutralizing agent.
2. The pharmaceutical composition of claim 1 , wherein said unit dosage form comprises a polysaccharide.
3. The pharmaceutical composition of claim 1 , wherein said unit dosage form comprises a mucoadhesive polymer.
4. The pharmaceutical composition of claim 3 , wherein said mucoadhesive polymer comprises carboxymethylcellulose, cellulose acetate, ethylcellulose, hydroxyethylcellulose, hydroxypropylmethylcellulose, nitrocellulose, polyoxyethylene/polyoxypropylene copolymer, or polyvinylpyrrolidone.
5. The pharmaceutical composition of claim 4 , wherein said mucoadhesive polymer comprises carboxymethylcellulose, cellulose acetate, ethylcellulose, hydroxyethylcellulose, or hydroxypropylmethylcellulose.
6. The pharmaceutical composition of claim 1 , further comprising an antioxidant.
7. The pharmaceutical composition of claim 1 , further comprising a permeation enhancer.
8. The pharmaceutical composition of claim 1 , further comprising glycerol monostearate.
9. The pharmaceutical composition of claim 1 , wherein said pH neutralizing agent is an organic base.
10. The pharmaceutical composition of claim 1 , wherein said first portion comprises apomorphine particles having an effective particle size of from 1 μm to 10 μm.
11. The pharmaceutical composition of claim 1 , wherein said acid addition salt of apomorphine is apomorphine hydrochloride.
12. The pharmaceutical composition of claim 1 , wherein said unit dosage form comprises from 2 to 40 mg of said acid addition salt of apomorphine.
13. A method of treating Parkinson's disease in a mammal afflicted with Parkinson's Disease, said method comprising administering an effective amount of the pharmaceutical composition of claim 1 to said mammal.