Journal of Bioequivalence & Bioavailability

Abstract

Pharmacokinetic/Pharmacodynamic Model for Aptensio XR® (an Extended-Release Methylphenidate Formulation) in 6-12 year-old Children

Andre J Jackson* and Inder Chaudhary

Aptensio XR^® is an Extended-Release (ER) Methylphenidate (MPH) capsule drug product, approved for use in patients 6 years and older. Absorption of Aptensio XR^® in children has been characterized by a fast first-order release and a delayed, slow first-order release. The current study investigated a Pharmacokinetic (PK) and Pharmacodynamic (PD) model for children 6-12 years-old (N=15). Determination of the PK parameters’ accuracy for pAUC (partial area under the curve) for times 0-3, 3-7, and 7-12 hours), C_max (maximum concentration), and AUC_0-T (area from time 0 to time T), for the 6-12 year-olds was calculated. All had bias less than 15% from the true observed values except for pAUC0-3 and C_max. This study also compared the current PD parameters with those previously reported from a meta- analysis (without children’s PK data) for MPH in children and adults for SKAMP scores (Swanson, Kotkin, Atkins, M-Flynn, and Pelham rating scale) and with those from this study for children ages 6-12. An indirect response model described the SKAMP composite scores corrected for placebo. The results of this study support the use of adult PK data to predict the SKAMP scores in children 6-12 years old for Aptensio XR^®.

Published Date: 2023-11-06; Received Date: 2023-10-05