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Last Updated: December 22, 2024

Claims for Patent: 10,420,763

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Summary for Patent: 10,420,763

Title:	Sublingual apomorphine
Abstract:	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.
Inventor(s):	Giovinazzo; Anthony John (Caledon, CA), Hedden; David Bruce (Ann Arbor, MI), De Somer; Marc L. (Winchester, MA), Bryson; Nathan John (Toronto, CA)
Assignee:	Sunovion Pharmaceuticals Inc. (Marlborough, MA)
Application Number:	16/005,105
Patent Claims:	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 .mu.m to 10 .mu.m. 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.

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