Claims for Patent: 9,044,475

Summary for Patent: 9,044,475

Title:	Sublingual apomorphine
Abstract:	The invention features sublingual formulations of apomorphine that is a mucoadhesive polymer film or a strip having a first portion including an acid addition salt of apomorphine and a second portion including a pH neutralizing agent, and methods of treating Parkinson's disease, sexual dysfunction, and depressive disorders by administering sublingually the film or strip.
Inventor(s):	Giovinazzo; Anthony John (Oakville, CA), Hedden; David Bruce (Ann Arbor, MI), de Somer; Marc L. (Lexington, MA), Bryson; Nathan John (Toronto, CA)
Assignee:	Cynapsus Therapeutics, Inc. (Toronto, CA)
Application Number:	12/813,820
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 layer and a second layer, said first layer comprising apomorphine particles comprising an acid addition salt of apomorphine and said second layer comprising a pH neutralizing agent that is an organic base, wherein (i) said unit dosage form is not effervescent, and (ii) said unit dosage form comprises a permeation enhancer. 2. The pharmaceutical composition of claim 1, wherein said unit dosage form comprises a polysaccharide. 3. The pharmaceutical composition of claim 1, wherein said film or a strip comprises a mucoadhesive polymer selected from carboxymethylcellulose, cellulose acetate, ethylcellulose, hydroxyethylcellulose, or hydroxypropylmethylcellulose. 4. The pharmaceutical composition of claim 1, wherein said acid addition salt of apomorphine is apomorphine hydrochloride. 5. The pharmaceutical composition of claim 1, further comprising an antioxidant. 6. The pharmaceutical composition of claim 1, wherein said permeation enhancer is glycerol monostearate. 7. The pharmaceutical composition of claim 1, wherein said first layer comprises apomorphine particles having an effective particle size of from 1 .mu.m to 10 .mu.m, wherein said apomorphine particles comprise an acid addition salt of apomorphine. 8. The pharmaceutical composition of claim 7, wherein said apomorphine particles comprise apomorphine hydrochloride. 9. The pharmaceutical composition of claim 8, wherein said unit dosage form comprises from 2 to 40 mg of an acid addition salt of apomorphine. 10. The pharmaceutical composition of claim 8, wherein said unit dosage form comprises apomorphine particles in a mucoadhesive polymer. 11. The pharmaceutical composition of claim 8, further comprising a third layer positioned between the first layer and the second layer. 12. The pharmaceutical composition of claim 9, wherein said unit dosage form comprises from 12 to 30 mg of an acid addition salt of apomorphine. 13. The pharmaceutical composition of claim 9, wherein said unit dosage form comprises 12.+-.3 mg of an acid addition salt of apomorphine. 14. The pharmaceutical composition of claim 9, wherein said unit dosage form comprises 22.+-.4 mg of an acid addition salt of apomorphine. 15. The pharmaceutical composition of claim 9, wherein said unit dosage form comprises 30.+-.5 mg of an acid addition salt of apomorphine. 16. The pharmaceutical composition of claim 9, wherein said unit dosage form comprises 35.+-.5 mg of an acid addition salt of apomorphine.