College of Pharmacy, Howard University, 2300 4th Street Washington DC 20059, USA
Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire, Dr., Silver Spring, MD, 20993.College of Pharmacy, Howard University, 2300 4th Street Washington DC 20059, USA
Research Article
A Semi-physiologically Based Model for Methylphenidate Pharmacokinetics in Adult Humans
Author(s): Andre J Jackson*
To determine if a literature-sourced physiological model for immediate-release (IR) methylphenidate (MPH), with addition of parameters for extended-release (ER) absorption can be adapted for NONMEM analysis to describe extended-release MPH drug products (i.e., Concerta® ER 54 mg tablets and Ritalin-LA® 40 mg capsules) pharmacokinetics (PK) in adults.
This semi-physiological model will provide a platform to allow more accurate determination of Cmax in the analysis of methylphenidate plasma data from formulations with complex absorption. Adult reference data for total MPH plasma levels (summation of d- and l- enantiomers) were generated using individual subject parameters from a published NONMEM model for ER MPH (individual subject parameter generated data was used because the true experimental data is proprietary with only the previous.. View more»