Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Capsules
Reexamination Certificate
2000-07-24
2010-06-22
Chong, Yong S (Department: 1627)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Capsules
C424S490000, C424S458000, C424S461000, C424S462000, C424S495000, C424S480000, C424S482000, C424S497000, C514S282000
Reexamination Certificate
active
07740881
ABSTRACT:
Solid controlled-release oral dosage forms comprising a therapeutically effective amount of an opioid analgesic or a salt thereof which provide an extended duration of pain relief of about 24 hours, have a dissolution rate in-vitro of the dosage form, when measured by the USP Paddle Method at 100 rpm at 900 ml aqueous buffer (pH between 1.6 and 7.2) at 37° C. of from about 12.5% to about 42.5% (by wt) opioid released after 1 hour, from about 25% to about 65% (by wt) opioid released after 2 hours, from about 45% to about 85% (by wt) opioid released after 4 hours, and greater than about 60% (by wt) opioid released after 8 hours, the in-vitro release rate being substantially independent of pH and chosen such that the peak plasma level of said opioid analgesic obtained in-vivo occurs from about 2 to about 8 hours after administration of the dosage form.
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Goldenheim Paul
Kaiko Robert
Sackler Richard
Chong Yong S
Davidson Davidson & Kappel LLC
Purdue Pharma LP
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