发明名称 |
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 mixtur es thereof, enantiomers thereof, pharmaceutically acceptable salts thereof, and combinations thereof in combination with at least one pharmaceutically-acceptable excipie nt 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 medi um having a pH between about 5.5 and about 7.5 at 37.0~ 0.5.degree.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.
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申请公布号 |
CA2415154(C) |
申请公布日期 |
2009.06.16 |
申请号 |
CA20022415154 |
申请日期 |
2002.12.24 |
申请人 |
BIOVAIL LABORATORIES INCORPORATED |
发明人 |
MAES, PAUL J.;MUHURI, GOUTAM |
分类号 |
A61K31/343;A61K9/28;A61K9/20;A61K9/22;A61K9/32;A61K31/00;A61K31/135;A61K31/137;A61K31/138;A61K31/15;A61K31/4525;A61K45/06 |
主分类号 |
A61K31/343 |
代理机构 |
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代理人 |
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主权项 |
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地址 |
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