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Bioavailability evaluation of a controlled-release dextromethorphan liquid.

J R Woodworth1, S R Dennis, O N Hinsvark

  • 1Pennwalt Pharmaceutical Division, Rochester, New York.

Journal of Clinical Pharmacology
|February 1, 1987
PubMed
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This study found that controlled-release dextromethorphan (DM) suspension is bioequivalent to immediate-release DM solution. The CR formulation provides prolonged drug release, offering a potentially improved dosing option for patients.

Area of Science:

  • Pharmacology
  • Clinical Pharmacy
  • Drug Development

Background:

  • Dextromethorphan (DM) is a widely used antitussive agent.
  • Optimizing DM delivery through controlled-release (CR) formulations can improve patient compliance and therapeutic outcomes.
  • Understanding the pharmacokinetic profile of CR DM is crucial for its clinical application.

Purpose of the Study:

  • To evaluate the bioavailability and pharmacokinetic characteristics of a novel controlled-release (CR) dextromethorphan (DM) suspension.
  • To compare the steady-state pharmacokinetics of CR DM suspension with an immediate-release (IR) DM solution.
  • To assess the drug release profile of the CR DM formulation in healthy volunteers.

Main Methods:

  • A randomized, two-way, steady-state crossover study involving 24 healthy male volunteers with specific CYP2D6 metabolizer phenotypes (slow and intermediate).

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  • Volunteers received either 30 mg immediate-release (IR) DM solution four times daily (qid) or 60 mg controlled-release (CR) DM suspension twice daily (bid) for two weeks, maintaining a total daily dose of 120 mg.
  • Plasma and urine samples were collected over 12-hour dosing intervals on the final day of each treatment phase for analysis of DM and its active metabolite, dextrorphan (DP).

    • Main Results:

    • The controlled-release (CR) dextromethorphan (DM) suspension was found to be bioequivalent to the immediate-release (IR) DM solution at steady state.
    • Pharmacokinetic analysis revealed a prolonged drug release profile for the CR DM suspension compared to the IR formulation.
    • Total urinary excretion data supported the bioequivalence and prolonged release findings.

    Conclusions:

    • The CR DM suspension demonstrates bioequivalence to the IR DM solution, confirming its suitability as an alternative formulation.
    • The CR formulation offers a prolonged drug release, potentially leading to improved dosing convenience and sustained therapeutic effect.
    • This study supports the clinical utility of CR DM suspension for conditions requiring dextromethorphan therapy.