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PHARMACOKINETICS

Pharmacokinetics, Tolerability, and Performance of a Novel Matrix Transdermal Delivery System of Fentanyl Relative to the Commercially Available Reservoir Formulation in Healthy Subjects

Jean-Francois Marier, PhD, Mary Lor, BSc, Diane Potvin, MSc, Marika DiMarco, PhD, Gaetano Morelli, MD and Eva Aggerholm Sædder, MD

From the MDS Pharma Services, Montreal (St-Laurent), Quebec, Canada (Dr Marier, Ms Lor, Ms Potvin, Dr DiMarco, Dr Morelli) and Nycomed, Roskilde, Denmark (Dr Sædder).

A novel transdermal formulation of fentanyl-containing dipropylene glycol droplets dispersed in a silicone matrix with a rate-controlling membrane was developed. Healthy male subjects (n = 24) received repeated 72-hour applications of fentanyl (50 µg/h) as the novel matrix and the conventional reservoir formulations in a randomized, 2-way crossover study. Blood samples were collected, and serum concentrations of fentanyl were assayed using liquid chromatography with mass spectrometry detection. The mean area under the curve (AUC{tau}) and peak concentrations (Cmax) of the matrix formulation were 84 838 pg·h/mL and 1680 pg/mL, respectively. Ratio and 90% confidence intervals of AUC{tau} and Cmax between the 2 formulations were within 80% to 125%. Adherence of the matrix formulation was higher than the reservoir formulation (62.5 vs 56.2%, P < .0001), without affecting skin irritation. Vital signs and adverse events of the 2 formulations were similar in nature and frequency. The novel matrix formulation displayed enhanced adherence and resulted in similar pharmacokinetics and tolerability as the reservoir formulation.

Key Words: Fentanyl • matrix transdermal delivery system • pharmacokinetics • tolerability

Address for reprints: Eva Aggerholm Sædder, MD, Nycomed, International Medical Affairs, Langebjerg 1, Postbox 88, 4000 Roskilde, Denmark; e-mail: evs{at}nycomed.com.


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