Hydrogel-driven layered drug dosage form

Details Hydrogel-driven layered drug dosage form Hydrogel-driven layered drug dosage form

2005-05-31

2005-05-31

Spear, James M. (Department: 1615)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Tablets, lozenges, or pills

C424S468000, C424S470000, C424S475000, C424S480000, C424S482000, C424S472000, C514S772200, C514S772300, C514S777000, C514S778000, C514S781000, C514S784000, C514S951000

Reexamination Certificate

active

06899896

ABSTRACT:
A controlled release dosage form for sertraline has a core comprising a sertraline-containing composition and a water-swellable composition wherein the water-swellable composition is in a separate region within the core. A coating around the core is water-permeable, water-insoluble, and has at least one delivery port therethrough. In one embodiment, the dosage form releases sertraline to the use environment at an average rate of 6 to 10 wt % per hour from the second to the twenth hour after introduction to a use environment and less than about 25 wt % for the first two hours and at least 70 wt % by the twelfth hour, where the percentages correspond to the mass of drug released from the tablet divided by the total mass of drug originally present in the tablet. In another embodiment, the dosage form releases less than about 25 wt % of sertraline to the use environment by the second hour after introduction of the dosage form to the use environment, and delivers at least 25 wt % from the eighth to the twenty-fourth hour.

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