Dose Control Study on Fentanyl Patch Using Two Types of Covering Material

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The morphine equivalent of a commercially available fentanyl patch preparation (2.5mg) is 45 to 134mg/day (p.o.). However, for lower doses, the adhesive surface of the patch is usually covered with a semi-blocked dressing (Tegaderm^[○!R] to control the dose. In the present study, both in vitro and in vivo experiments were carried out to examine the drug release characteristics from such patches. In vitro, the drug release characteristics of a fentanyl patch (2.5mg) with its entire surface covered with Tegaderm^[○!R] and those of a cover-free patch were compared in simulated sweat (pH 4.5), according to the dissolution test method for transdermal systems specified in the U.S. Pharmacopoeia (USP 28, paddle over disk method). Comparing the fentanyl content of the samples by HPLC showed that there was no significant difference in the percentages of drug released from either patch. In the in vivo experiment, patches were attached to the shaved backs of rabbits (n=3) and blood samples were sequentially collected for 72 hours. Measuring the fentanyl content of serum samples by HPLC/ESI-MS showed that though the drug absorption rate was significantly reduced for the patch covered with Tegaderm^[○!R], the serum concentration was still at a high level after 72 hours. Also, AUC 0-72h for the patch covered with Tegaderm^[○!R] was more than 50% of the free patch suggesting that fentanyl was released through the Tegaderm^[○!R] covering. When the entire surface of the fentanyl patch was covered with Saran wrap^[○!R] instead of Tegaderm^[○!R], no appreciable permeation of the drug was observed and when half of the patch surface was covered with Saran wrap^[○!R], the AUC value was around half that of the wrap-free patch. Saran wrap^[○!R] is therefore potentially useful as an auxiliary material for dose control.
日本医療薬学会の論文
2008-01-10

Dose Control Study on Fentanyl Patch Using Two Types of Covering Material

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