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Single-dose pharmacokinetics of multilayer-release methylphenidate and immediate-release methylphenidate in children

Declan Quinn1, Twyla Bode, Joseph L Reiz

  • 1Royal University Hospital, Saskatoon, Saskatchewan, Canada.

Journal of Clinical Pharmacology
|March 31, 2007
PubMed

Insights

This study compared two methylphenidate formulations for attention-deficit/hyperactivity disorder (ADHD). Multilayer-release methylphenidate demonstrated a biphasic profile, maintaining plasma concentrations throughout the school day.

Area of Science:

  • Pharmacology
  • Neuroscience
  • Pediatrics

Background:

  • Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental disorder.
  • Methylphenidate is a widely prescribed stimulant medication for ADHD treatment.
  • Optimizing methylphenidate delivery systems is crucial for sustained symptom control.

Purpose of the Study:

  • To compare the single-dose pharmacokinetics of multilayer-release (MLR) methylphenidate versus immediate-release (IR) methylphenidate.
  • To evaluate the plasma concentration-time profiles of MLR-methylphenidate in children with ADHD.
  • To assess the suitability of MLR-methylphenidate for maintaining therapeutic levels throughout the school day.

Main Methods:

  • Randomized, crossover study design in children aged 6-12 years with ADHD.
  • Administration of equivalent doses of MLR-methylphenidate (once daily) and IR-methylphenidate (twice daily).
  • Serial plasma sampling for pharmacokinetic analysis over 24 hours post-dose.

Main Results:

  • The relative AUC(0-t) for MLR vs. IR methylphenidate was 100.8%.
  • The relative C(max 0-4) for MLR vs. IR methylphenidate was 78.8%.
  • MLR-methylphenidate exhibited a biphasic concentration-time profile, with initial rapid absorption and sustained levels.

Conclusions:

  • MLR-methylphenidate provides a pharmacokinetic profile suitable for once-daily dosing in children with ADHD.
  • The biphasic release pattern of MLR-methylphenidate ensures sustained therapeutic concentrations.
  • This formulation may offer improved adherence and efficacy compared to IR methylphenidate.

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