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Related Experiment Videos

Methylphenidate bioavailability from two extended-release formulations.

M A González1, H S Pentikis, N Anderl

  • 1GloboMax Américas, Weston, FL, USA.

International Journal of Clinical Pharmacology and Therapeutics
|May 9, 2002
PubMed
Summary
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The extended-release methylphenidate (MPH) capsule formulation showed greater early exposure compared to the OROS tablet, indicating they are not bioequivalent. This difference is significant for school children during the school day.

Area of Science:

  • Pharmacology
  • Pharmacokinetics
  • Drug Delivery Systems

Background:

  • Methylphenidate (MPH) is a central nervous system stimulant commonly prescribed for conditions like ADHD.
  • Extended-release formulations aim to provide sustained drug delivery throughout the day.
  • Comparing different MPH formulations is crucial for optimizing therapeutic outcomes.

Purpose of the Study:

  • To compare the absorption rate and extent of d,l-threo-methylphenidate (MPH) from two extended-release products: a capsule formulation with coated beads and an OROS tablet formulation.
  • To assess the pharmacokinetic profiles of these two MPH formulations in healthy adults under fasted conditions.

Main Methods:

  • Two single-dose, randomized crossover studies were conducted in healthy adults.
  • Pharmacokinetic parameters were determined by analyzing plasma MPH concentrations over 24 hours.

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  • Bioequivalence was assessed using 90% confidence intervals for the ratio of test to reference means, with 80-125% considered equivalent.

    • Main Results:

    • Both formulations demonstrated biphasic plasma concentration-time profiles and were equivalent in total drug exposure (AUC).
    • The capsule formulation resulted in significantly greater early exposure (AUC(0-4), AUC(0-6), C(max-1)) and higher plasma MPH concentrations at earlier time points (1.5, 3, 4 hours).
    • The OROS tablet formulation showed higher plasma MPH concentrations at later time points (8, 10, 12 hours), with confidence intervals outside the bioequivalence range.

    Conclusions:

    • The extended-release methylphenidate capsule and OROS tablet formulations are not bioequivalent.
    • The capsule formulation provides greater MPH exposure and higher concentrations during the initial 6 hours post-dosing.
    • This difference in early exposure may be relevant for maintaining therapeutic drug levels during a significant portion of the school day for pediatric patients.