Pharmacokinetics and Bioequivalence of a Novel Extended-Release Formulation of Methylphenidate Hydrochloride for Attention-Deficit/Hyperactivity Disorder.

ABSTRACT: Extended-release (ER) formulations of the stimulant methylphenidate are commonly used to treat attention-deficit/hyperactivity disorder in both children and adults. Previous studies have shown that the clinical effectiveness of long-acting methylphenidate formulations is closely tied to the drug's pharmacokinetic (PK) profile, highlighting the need for consistency in drug exposure. ODX-methylphenidate ER uses an osmotic pump design to provide controlled release of drug over the course of the day. In these similarly designed 4-period replicate crossover studies, the PK profile of ODX-methylphenidate ER was compared to the reference product, osmotic release oral system (OROS)-methylphenidate ER, in healthy subjects in the fasted state. In the first trial (N = 60), a single 72-mg tablet of OD

SUBMITTER: Childress AC 

PROVIDER: S-EPMC12583981 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature