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Ene Ette
Anoixis Pharmacometric Services, 214 N. Main Street, Natick Massachusetts, USA
Publications
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Research Article
Semi-Physiological based Population Pharmacokinetic Model for Methylphenidate Hydrochloride Multi-Layer Extended Release (Aptensio XR®) Capsules in Children ages 4-12 and Adults
Author(s): Andre J Jackson*, Richard Brundage, Ene Ette and Inder Chaudhary
Aptensio XR® is an Extended-Release (ER) Methylphenidate (MPH) capsule drug product, approved for use in patients 6 years and above. Clinical studies have been conducted in adults (N=24), children ages 6-12 (N=15), and pre-school children ages 4-5 (N=9) with approved doses in children aged 6 and above at 10, 15, 20, 30, 40, 50, and 60 mg. The purpose of this investigation is to determine if a semi-physiological model for ER MPH can adequately describe Aptensio XR® (bead formulation) clinical data in children ages 4-12 and adults. Absorption of Aptensio XR® in children has been characterized by two fast first-order releases and a delayed slow first-order release and in adults by a fast zero-order release and a delayed first-order release. Both are consistent with published MPH models for these demographic groups. Subject.. View more»