J Clin Pharmacol
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PEDIATRICS

Single-Dose Pharmacokinetics of Roflumilast in Children and Adolescents

Kathleen A. Neville, MD, MS, Stanley J. Szefler, MD, Susan M. Abdel-Rahman, PharmD, Gezim Lahu, MSc, Karl Zech, PhD, Rolf Herzog, Thomas D. Bethke, MD, Melanie C. Gleason, MS, PA-C and Gregory L. Kearns, PharmD, PhD, FCP

From the Department of Pediatrics, University of Missouri–Kansas City and the Children's Mercy Hospitals and Clinics, Kansas City, Missouri (Dr Neville, Dr Abdel-Rahman, Dr Kearns); National Jewish Medical and Research Center, Denver, Colorado (Dr Szefler, Ms Gleason); and Nycomed GmbH, Konstanz, Germany (Mr Lahu, Dr Zech, Mr Herzog, Dr Bethke).

Roflumilast is an orally administered phosphodiesterase 4 inhibitor that has potential for use in pediatric patients with asthma. The pharmacokinetics of roflumilast and roflumilast N-oxide were examined in adolescents and children with stable mild to moderate asthma in an open-label crossover study with age-stratification and 2 treatment periods (100-µg dose in period 1, 250-µg dose in period 2) separated by a washout period. Plasma concentrations were measured by high-performance liquid chromatography tandem mass spectrometry. Pharmacokinetic parameters were determined using standard noncompartmental methods and compared between study groups and within the entire cohort. Roflumilast was well tolerated. Linear relationships were evident for dose and area under the plasma drug concentration–time curve extrapolated to infinity for both roflumilast (r2 = 0.36, P < .01) and roflumilast N-oxide (r2 = 0.39, P < .01). With the exception of dose-normalized maximum plasma concentration (mean 1.1 and 0.8 µg/L per 1 µg/kg dose for adolescents and children, respectively), pharmacokinetic parameters for roflumilast and roflumilast N-oxide were not different between age groups and were similar to adults.

Key Words: Roflumilast • pharmacokinetics • children • adolescents • phosphodiesterase inhibitor

Address for reprints: Gregory L. Kearns, PharmD, PhD, FCP, Division of Pediatric Pharmacology and Medical Toxicology, The Children's Mercy Hospitals and Clinics, 2401 Gillham Road, Kansas City, MO 64079; e-mail: gkearns{at}cmh.edu.


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