Comparative bioequivalence study between a novel matrix transdermal delivery system of fentanyl and a commercially available reservoir formulation.
OBJECTIVE
To determine the pharmacokinetics, safety and performance of a novel matrix formulation of fentanyl.


METHODS
Transdermal fentanyl was administered as the novel matrix and the Durogesic reservoir formulations (24 subjects, 100 microg h(-1)) in a randomized, fully replicate, four-way crossover study. Serum concentrations of fentanyl were assayed by LC/MS/MS. Pharmacokinetic parameters of fentanyl and performance (adherence and skin irritability) were evaluated.


RESULTS
Test/reference ratio (90% confidence intervals) for AUC(0-t), AUC(inf) and C(max) were 105.5% (99.4, 112.0), 105.3% (99.3, 111.6) and 111.4% (100.4, 123.6), respectively. Adherence and skin irritability results of the two formulations were similar.


CONCLUSIONS
The two formulations are expected to result in similar efficacy for the management of severe pain.
Marier
Jean-Francois
JF
MDS Pharma Services, Montreal (St-Laurent), Quebec, Canada.
Lor
Mary
M
Morin
Josée
J
Roux
Lionel
L
Di Marco
Marika
M
Morelli
Gaetano
G
Saedder
Eva Aggerholm
EA
D000279:Administration, Cutaneous; D000328:Adult; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000493:pharmacokinetics*; D018592:Cross-Over Studies; D016503:Drug Delivery Systems; D005283:Fentanyl / Q000008:administration & dosage / Q000493:pharmacokinetics*; D006801:Humans; D008297:Male; D008875:Middle Aged; D013810:Therapeutic Equivalency
D000701:Analgesics, Opioid; D005283:Fentanyl