主权项 |
1. A transdermal patch for administration of fentanyl through the skin, comprising:
a backing layer; a reservoir disposed on the backing layer, at least the skin contacting surface of the reservoir being adhesive; the reservoir comprising a polymeric composition containing 0.14 to 0.3 mg/cm2 of fentanyl, an area normalized to dose strength of 0.2 to 0.4 cm2 per μg/h fentanyl nominally for one-day delivery, and a normalized fentanyl content of about 0.04 to 0.08 mg/(μg/h), said fentanyl being sufficient to induce and maintain analgesia in a human for one day, wherein daily replacement application of one patch on the skin achieves a steady state plasma level effective for analgesia, and wherein said reservoir contains residual fentanyl base of less than 30 wt % after one day of use. |