Pharmaceutical forms of modified release of 5-HT2C agonists useful for weight management
2011
A modified release dosage form comprising a therapeutically effective amount of a salt selected from: (R) -8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride and its solvates and pharmaceutically acceptable hydrates, wherein said modified release dosage form is a tablet; wherein said modified release dosage form comprises a polymer matrix of speed control; wherein said matrix comprises: (i) said salt; and (ii) a speed control polymer; wherein said salt is dispersed in said speed controlling polymer; wherein said speed control polymer is (hydroxypropyl) methyl cellulose; wherein said tablet further comprises a film coating; wherein said film coating comprises ethyl cellulose and (hydroxypropyl) methyl cellulose; wherein the ratio of said ethyl cellulose to said (hydroxypropyl) methyl cellulose in said film coating is: about 75:25, about 80:20 or about 85:15; wherein said modified release dosage form provides a rate of release for which, the time to achieve 80% cumulative release of (R) -8-chloro-1-methyl-2,3,4,5-tetrahydro- 1H-3-benzazepine (T80%) is at least 3 hours, as determined using a USP I apparatus (basket method) in 900 ml of a 0.1 N HCl solution at 37 ° C and 100 rpm.
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