TY - JOUR
T1 - Transdermal fentanyl matrix patches Matrifen and Durogesic DTrans are bioequivalent
AU - Kress, Hans G
AU - Boss, Hildegard
AU - Delvin, Thomas
AU - Lahu, Gezim
AU - Lophaven, Søren
AU - Marx, Michael
AU - Skorjanec, Sophie
AU - Wagner, Thomas
N1 - Copyright 2010 Elsevier B.V. All rights reserved.
PY - 2010/6
Y1 - 2010/6
N2 - Aim: The pharmacokinetic profiles of the two commercially available transdermal fentanyl patches Matrifen® (100μg/h) and Durogesic® DTrans® (100μg/h), used to manage severe chronic pain, were compared regarding their systemic exposure, rate of absorption, and safety. Methods: Transdermal matrix fentanyl patches [Matrifen® or Durogesic® DTrans® (100μg/h)] were applied for 72. h to 30 healthy male subjects in a randomized, four-period (two replicated treatment sequences), crossover study; 28 subjects completed the study. The pharmacokinetic parameters of fentanyl were determined for 144. h after application using plasma samples. Safety of the patches (adverse events) and performance (adhesion, skin irritation, residual fentanyl content in the patch) were evaluated. Results: The plasma concentration-time curves of Matrifen® (Test) and Durogesic® DTrans® (Reference) were similar. The geometric least square means of the Test/Reference ratio (90% confidence intervals [CI]) were within the range of 80-125%, demonstrating bioequivalence of Matrifen® and Durogesic® DTrans®: AUC0-tlast 92.5 (CI 88.7-96.4), AUC0-inf 91.7 (CI 88.0-95.7), and Cmax 98.3 (CI 92.9-104.1). After 72h application, Matrifen® had a more efficient utilization of fentanyl (mean±SD 82.3±9.43%) than Durogesic® DTrans® (52.3±12.8%), with substantially lower residual fentanyl in patch after use. The pharmacokinetic parameters showed lower intra- and inter-subject variability for Matrifen® than for Durogesic® DTrans® patch. Conclusions: Despite different technologies, the transdermal fentanyl patches Matrifen® and Durogesic® DTrans® are bioequivalent. Compared with Durogesic® DTrans®, the Matrifen® patch had lower initial and lower residual fentanyl content, as well as lower intra- and inter-subject variability, allowing reproducible drug delivery and reliable analgesia.
AB - Aim: The pharmacokinetic profiles of the two commercially available transdermal fentanyl patches Matrifen® (100μg/h) and Durogesic® DTrans® (100μg/h), used to manage severe chronic pain, were compared regarding their systemic exposure, rate of absorption, and safety. Methods: Transdermal matrix fentanyl patches [Matrifen® or Durogesic® DTrans® (100μg/h)] were applied for 72. h to 30 healthy male subjects in a randomized, four-period (two replicated treatment sequences), crossover study; 28 subjects completed the study. The pharmacokinetic parameters of fentanyl were determined for 144. h after application using plasma samples. Safety of the patches (adverse events) and performance (adhesion, skin irritation, residual fentanyl content in the patch) were evaluated. Results: The plasma concentration-time curves of Matrifen® (Test) and Durogesic® DTrans® (Reference) were similar. The geometric least square means of the Test/Reference ratio (90% confidence intervals [CI]) were within the range of 80-125%, demonstrating bioequivalence of Matrifen® and Durogesic® DTrans®: AUC0-tlast 92.5 (CI 88.7-96.4), AUC0-inf 91.7 (CI 88.0-95.7), and Cmax 98.3 (CI 92.9-104.1). After 72h application, Matrifen® had a more efficient utilization of fentanyl (mean±SD 82.3±9.43%) than Durogesic® DTrans® (52.3±12.8%), with substantially lower residual fentanyl in patch after use. The pharmacokinetic parameters showed lower intra- and inter-subject variability for Matrifen® than for Durogesic® DTrans® patch. Conclusions: Despite different technologies, the transdermal fentanyl patches Matrifen® and Durogesic® DTrans® are bioequivalent. Compared with Durogesic® DTrans®, the Matrifen® patch had lower initial and lower residual fentanyl content, as well as lower intra- and inter-subject variability, allowing reproducible drug delivery and reliable analgesia.
KW - Administration, Cutaneous
KW - Adult
KW - Analgesics, Opioid
KW - Area Under Curve
KW - Cross-Over Studies
KW - Drug Delivery Systems
KW - Fentanyl
KW - Humans
KW - Least-Squares Analysis
KW - Male
KW - Middle Aged
KW - Therapeutic Equivalency
KW - Young Adult
U2 - 10.1016/j.ejpb.2010.02.005
DO - 10.1016/j.ejpb.2010.02.005
M3 - Journal article
C2 - 20152899
SN - 0939-6411
VL - 75
SP - 225
EP - 231
JO - European Journal of Pharmaceutics and Biopharmaceutics
JF - European Journal of Pharmaceutics and Biopharmaceutics
IS - 2
ER -