MODIFIED RELEASE FORMULATIONS OF SELECTIVE SEROTONIN RE-UPTAKE INHIBITORS

摘要

A modified release pharmaceutical composition for oral administration, suitable for once daily dosing, comprising a form of at least one selective serotonin re- uptake inhibitor (SSRI) selected from the group consisting of SSRIs, racemic mixtures thereof, enantiomers thereof, pharmaceutically acceptable salts thereof, and combinations thereof in combination with at least one pharmaceutically-acceptable excipient wherein the pharmaceutical composition exhibits the following in vitro dissolution profile when measured using the USP Paddle Method at 100 rpm in 900 mL of a buffered medium having a pH between about 5.5 and about 7.5 at 37.0~ 0.5°C: (a) between about 0% and about 50% (by wt) of the form of the at least one SSRI is released after about 1 hour; (b) between about 0% and about 75% (by wt) of the form of the at least one SSRI is released after about 2 hours; (c) between about 3% and about 95% (by wt) of the form of the at least one SSRI is released after about 4 hours; (d) between about 10% and about 100% (by wt) of the form of the at least one SSRI is released after about 8 hours; (e) between about 20% and about 100% (by wt) of the form of the at least one SSRI is released after about 12 hours; (f) between about 30% and about 100% (by wt) of the form of the at least one SSRI is released after about 16 hours; (g) between about 50% and about 100% (by wt) of the form of the at least one SSRI is released after about 24 hours; and (h) in excess of about 80% (by wt) of the form of the at least one SSRI is released after about 36 hours.