Open Access(618) The Assessment of the Impact of Heat on the Systemic Delivery of Fentanyl Through the Transdermal Fentanyl Delivery System
Author(s) -
Y. Eugene Mironer
Publication year - 2000
Publication title -
pain medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.893
H-Index - 97
eISSN - 1526-4637
pISSN - 1526-2375
DOI - 10.1046/j.1526-4637.2000.000024-17.x
Subject(s) - transdermal , fentanyl , medicine , drug delivery , delivery system , analgesic , anesthesia , transdermal patch , pharmacology , chemistry , organic chemistry
Authors: T Samuel Shomaker, University of Utah; Michael Ashburn, University of Utah Introduction: The noninvasive delivery of analgesic medications has the potential to improve patient acceptance, reduce variability of serum drug concentrations, and smooth peak and trough concentrations that disadvantage traditional modes of drug administration. This abstract reports the results of a study of the use of locally applied heat on the systemic delivery of fentanyl through the Transdermal Fentanyl Delivery System. Study Type: Open, 2‐period crossover, randomized. Method: Six healthy adult volunteers received 2 administrations of a fentanyl 2.5 mcg/h patch with and without local heat for 240 minutes, followed by administration without heat for an additional 20 hours. Participants then crossed over and repeated the study. Vital signs and oxygen saturations were monitored. Venous blood was drawn at baseline and every hour up to 24 hours to determine mean peak plasma concentrations (CMAX) of fentanyl and to evaluate the area under the curve (AUC) of the plasma fentanyl concentration versus time post‐administration graph. Results: For heat administration CMAX was seen at a median of 17 hours, with an average maximum concentration of 0.6 ng/ml compared with 23 hours at a maximum concentration of 0.6 ng/ml for no heat. AUC for the 24‐hour period averaged 548 ng/ml min for heat versus 495 ng/ml min for no heat. No differences were statistically significant. However, for the 4‐hour period of heat application, statistically significant differences were seen in both mean CMAX (heat 0.4 ng/ml versus no heat 0.1 ng/ml ( P = .030)) and mean AUC (heat 40 ng/ml min versus no heat 10 ng/ml min ( P = .010)). There were no statistically significant differences in vital signs or oxygen saturation. All subjects reported side effects with an average of 2.3 per subject for each administration. Low oxygen saturation and nausea were most commonly reported, but all events were mild or moderate. Conclusion: These results suggest that heat can decrease time to the onset of steady state fentanyl concentration. If the increased rate of fentanyl delivery using heat can be reliably produced in a larger study the potential exists to improve the efficiency and safety of the Fentanyl Transdermal Delivery System.