부산대학교 도서관

To purchase or authenticate to the full-text of this article, please visit this link: http://dx.doi.org/10.1111/j.1365-2125.2006.02758.x Byline: Jean-Francois Marier, Mary Lor, Josee Morin, Lionel Roux, Marika Di Marco, Gaetano Morelli, Eva Aggerholm Saedder (1) Keywords: fentanyl; matrix transdermal delivery system; performance; pharmacokinetics; safety 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.sup.[R] reservoir formulations (24 subjects, 100 [micro]g h.sup.-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.sub.0-t, AUC.sub.inf and C.sub.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. Author Affiliation: (1)Nycomed, Roskilde, Denmark Article History: Received7 October 2005Accepted3 June 2006Published OnlineEarly30 August 2006 Article note: Eva Aggerholm Saedder MD, Medical Advisor, NYCOMED, International Medical Affairs, Langebjerg 1, Postbox 88, 4000 Roskilde, Denmark., Tel: +45 46 77 11 11, Fax: +45 46 75 59 99, E-mail: amgr@nycomed.com