Dose-Proportional Pharmacokinetics of d-threo-Methylphenidate After a Repeated-Action Release Dosage Form

A bimodal extended‐release formulation of d‐methylphenidate (d‐MPH) has been developed to enable fast onset of action and once‐daily administration in patients with attention deficit hyperactivity disorder. The authors studied the dose proportionality of extended‐release d‐MPH pharmacokinetics. Twen...

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Bibliographic Details
Published in:Journal of clinical pharmacology 2007-01, Vol.47 (1), p.64-69
Main Authors: Tuerck, Dietrich, Appel-Dingemanse, Silke, Maboudian, Mojdeh, Pommier, Francoise, Wang, Yibin, Sedek, Greg
Format: Article
Language:English
Subjects:
Administration, Oral
Adult
Area Under Curve
Chromatography, High Pressure Liquid
Controlled release
Controlled release preparations
Cross-Over Studies
d-MPH
Delayed-Action Preparations - administration & dosage
Delayed-Action Preparations - pharmacokinetics
Dopamine Agents - administration & dosage
Dopamine Agents - blood
Dopamine Agents - pharmacokinetics
Dosage and administration
dose proportionality
Dose-Response Relationship, Drug
Drug Tolerance
Drugs
extended release
Female
Health aspects
human
Humans
Male
Methylphenidate
Methylphenidate - administration & dosage
Methylphenidate - blood
Methylphenidate - pharmacokinetics
Methylphenidate hydrochloride
Pharmacokinetics
Stereoisomerism
Tandem Mass Spectrometry
Time Factors
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Summary:A bimodal extended‐release formulation of d‐methylphenidate (d‐MPH) has been developed to enable fast onset of action and once‐daily administration in patients with attention deficit hyperactivity disorder. The authors studied the dose proportionality of extended‐release d‐MPH pharmacokinetics. Twenty‐five healthy adult volunteers received 5, 10, 20, 30, and 40 mg d‐MPH in a crossover study with 7 days between doses. All doses were well tolerated. Dose proportionality was shown for all dose‐dependent pharmacokinetic parameters. Geometric means (%gCV) for the first Cmax peak, Cmax 0–4, were 3.25 (29.0%), 6.05 (27.1%), 12.6 (31.9%), 18.5 (31.9%), and 25.2 ng/mL (29.3%) for d‐MPH 5, 10, 20, 30, and 40 mg, respectively. Geometric means (%gCV) for Cmax4–10 were 3.18 (27.5%), 5.84 (27.7%), 12.5 (31.7%), 17.7 (31.6%), and 23.6 ng/mL (29.0%), respectively. Geometric means for AUC0‐∞ were 24.3 (30.7%), 45.9 (30.2%), 96.4 (35.5%), 144 (33.3%), and 195 ng • h/mL (30.9%), respectively. The pharmacokinetics of once‐daily extended‐release d‐MPH are proportional to the dose.
ISSN:0091-2700
1552-4604
DOI:10.1177/0091270006293757