Comparative bioequivalence study between a novel matrix transdermal delivery system of fentanyl and a commercially available reservoir formulation |
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| Authors: | Marier Jean-Francois Lor Mary Morin Josée Roux Lionel Di Marco Marika Morelli Gaetano Saedder Eva Aggerholm |
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| Affiliation: | MDS Pharma Services, Montreal (St-Laurent), Quebec, Canada. |
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| Abstract: | AIM: 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. CONCLUSION: The two formulations are expected to result in similar efficacy for the management of severe pain. |
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| Keywords: | fentanyl matrix transdermal delivery system performance pharmacokinetics safety |
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