Reproducible fentanyl doses delivered intermittently at different time intervals from an electrotransport system

Abstract

The electrotransport transdermal fentanyl system (ET [fentanyl]), uses a small electrical current to enhance delivery of fentanyl to systemic circulation. Intermittent doses can be administered by periodic application of the current. The purpose of this study was to compare the effects of the frequency of intermittent drug delivery by ET (fentanyl) and compare the drug delivery to systemic circulation by ET (fentanyl) with intravenous administration. The topical safety was also determined for the ET (fentanyl) system. Nine adult male volunteers completed this three-treatment, randomized, 24-h, crossover study. ET (fentanyl) treatments with 200 microA direct current applied for 30 min at frequent (hourly) or infrequent (4-hourly) intervals over a 24-h period were compared. Also, the drug delivery to systemic circulation from ET (fentanyl) was compared with intravenous fentanyl 75 microg infused over 30 min every 4 h over a 24-hour period. The mean serum fentanyl concentration achieved with the hourly ET (fentanyl) regimen was higher than that for the 4-hourly ET (fentanyl) regimen as expected from the higher frequency of drug doses. The amount of fentanyl delivered estimated per dose from the ET (fentanyl) system using the iv fentanyl treatment as the reference was similar for the two ET regimens throughout the dosing period. This indicates consistent drug delivery regardless of the frequency of ET dosing. The majority of subjects reported either no, or barely perceptible, erythema 24 h after removal of the system.

Dermal and Transdermal Drug Delivery Systems: Current and Future Prospects

“…This operates in a similar manner to the Vyteris system. The NDA application is based on the ability of this system to enhance the delivery of fentanyl into the systemic circulation via the skin (Gupta et al 1998(Gupta et al , 1999. Fentanyl is an opioid analgesic used in the treatment of acute pain and the E-TRANS fentanyl system reportedly allows patient-controlled delivery of this pain medication and represents an improvement in pain management compared with intravenous injections and oral dosing methods (Alza 2005).…”

Patient-controlled Modalities for Acute Postoperative Pain Management

“…[67][68][69][70] Fentanyl, a shortacting synthetic opioid, has been used safely and effectively for 30 years to manage both acute and chronic pain. [71][72][73] Unlike morphine, fentanyl does not have active metabolites that accumulate over time. 74 Pharmacokinetic stud-CHRISTINE MIASKOWSKI 258 ies have shown that absorption of fentanyl from the PCTS system is not affected by demographic characteristics such as age, gender, ethnicity, or body weight.…”

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“…Improved drug permeation as a result of this methodology can be attributed to either one or a combination of the following mechanisms: Electro-repulsion (for charged solutes), electro-osmosis (for uncharged solutes) and electro-pertubation (for both charged and uncharged). Various iontophoretic devices are currently under commercial development including the Phoresor device developed by Iomed Inc. and the Vyteris and E-TRANS devices developed by Alza Corp 6,7 .…”