Sublingual films
First Claim
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1. A pharmaceutical composition in unit dosage form formulated for sublingual administration, wherein said unit dosage form is a film comprising (i) from 25±
- 5% to 40±
5% (w/w) an acid addition salt of apomorphine and (ii) from 6±
2% to 65±
5% (w/w) a pH neutralizing agent that is an inorganic base selected from sodium phosphate monobasic, sodium phosphate dibasic, sodium phosphate tribasic, potassium phosphate monobasic, potassium phosphate dibasic, and potassium phosphate tribasic, wherein said film comprises particles comprising an acid addition salt of apomorphine and particles comprising said inorganic base.
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Abstract
The invention features sublingual film formulations of dopamine agonists and methods of treating Parkinson'"'"'s disease, tremors, restless leg syndrome, sexual dysfunction, and depressive disorders therewith.
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23 Claims
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1. A pharmaceutical composition in unit dosage form formulated for sublingual administration, wherein said unit dosage form is a film comprising (i) from 25±
- 5% to 40±
5% (w/w) an acid addition salt of apomorphine and (ii) from 6±
2% to 65±
5% (w/w) a pH neutralizing agent that is an inorganic base selected from sodium phosphate monobasic, sodium phosphate dibasic, sodium phosphate tribasic, potassium phosphate monobasic, potassium phosphate dibasic, and potassium phosphate tribasic, wherein said film comprises particles comprising an acid addition salt of apomorphine and particles comprising said inorganic base. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23)
- 5% to 40±
Specification