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Dose‐Proportional Pharmacokinetics of d‐threo ‐Methylphenidate After a Repeated‐Action Release Dosage Form
Author(s) -
Tuerck Dietrich,
AppelDingemanse Silke,
Maboudian Mojdeh,
Pommier Francoise,
Wang Yibin,
Sedek Greg
Publication year - 2007
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270006293757
Subject(s) - pharmacokinetics , cmax , methylphenidate , crossover study , pharmacology , geometric mean , medicine , anesthesia , mathematics , attention deficit hyperactivity disorder , placebo , pathology , psychiatry , statistics , alternative medicine
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 C max peak, C max 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 C max4–10 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 AUC 0‐∞ 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.