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US 11,026,939 B2Granted
High dosage valbenazine formulation and compositions, methods, and kits related thereto
AssigneeNeurocrine Biosciences, Inc.
InventorsRichard Alexander Moore, Jr., Gregory A. McClelland, Christopher F. O{grave over ( )}Brien
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Abstract
Solid pharmaceutical compositions with high drug loading are provided. A formulation useful for the solid pharmaceutical composition includes valbenazine, or a pharmaceutically acceptable salt thereof, silicified microcrystalline cellulose, isomalt, hydroxypropyl methylcellulose, partially pregelatinized maize starch, and magnesium stearate.
Claims29
A unit dosage form comprising:
- (S)-2-amino-3-methyl-butyric acid (2R,3R,11bR)-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-yl ester ditosylate;
- silicified microcrystalline cellulose;
- isomalt;
- hydroxypropyl methylcellulose;
- partially pregelatinized maize starch;
- and
- magnesium stearate;
- wherein (S)-2-amino-3-methyl-butyric acid (2R,3R,11bR)-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-yl ester ditosylate is present at a level ranging from about 20 mg to 160 mg as measured as the free base, and
- (S)-2-amino-3-methyl-butyric acid (2R,3R,11bR)-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-yl ester ditosylate is present at a level of at least 30% by weight of the total weight of the unit dosage form.
6 more elements
Dependencies are inferred from the claim text.