Comparative Bioavailability of Methylphenidate Powder for Prolonged-Release Oral Suspension and Methylphenidate Prolonged-Release Chewable Tablets versus Methylphenidate Immediate-Release Tablets: Phase 1, Single-Dose, Randomised, Crossover Studies in Healthy Adults.

ABSTRACT:

Background

Various oral methylphenidate formulations are available to treat attention-deficit/hyperactivity disorder, but unmet needs still exist, particularly for individuals with swallowing difficulties or those requiring more flexible dosing options. Two phase 1 studies evaluated the comparative bioavailability and safety/tolerability of two prolonged-release (PR) methylphenidate formulations, an oral suspension and a chewable tablet, compared with an established immediate-release (IR) oral tablet formulation.

Methods

Healthy volunteers were randomised to receive a single dose of methylphenidate PR oral suspension (total dose 60 mg; study 1) or chewable tablet (total dose 40 mg; study 2) and methylphenidate IR tablets (total dose 60 mg in study 1 and 40 mg in study 2) in

SUBMITTER: Ramos-Quiroga JA 

PROVIDER: S-EPMC12669362 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature