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Related Experiment Videos

Comparative bioavailability study of three sustained release quinidine formulations.

W A Mahon, J S Leeder, M M Brill-Edwards

    Clinical Pharmacokinetics
    |August 1, 1987
    PubMed
    Summary

    This study compared three sustained-release quinidine formulations. While overall absorption extent was similar, Quinidex showed slower absorption and higher steady-state trough concentrations than Biquin Durules and Quinaglute Dura-Tabs.

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    Area of Science:

    • Pharmacokinetics
    • Drug Absorption
    • Clinical Pharmacology

    Background:

    • Sustained-release formulations aim to provide consistent drug levels.
    • Quinidine is an antiarrhythmic agent requiring careful dose management.
    • Understanding absorption differences between formulations is crucial for therapeutic efficacy.

    Purpose of the Study:

    • To compare the absorption characteristics of three different sustained-release quinidine formulations.
    • To evaluate peak concentrations, absorption rates, and steady-state trough levels.
    • To determine if absorption models (zero-order vs. first-order) differ between formulations.

    Main Methods:

    • A randomized, 3-way crossover trial involving 12 healthy male volunteers.
    • Administration of single tablets of Quinidex (300mg), Biquin Durules (250mg), and Quinaglute Dura-Tabs (324mg) every 12 hours for 5 days.

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  • Measurement of quinidine serum concentrations and analysis using pharmacokinetic parameters and Wagner-Nelson plots.

    • Main Results:

    • Peak quinidine serum concentrations were significantly higher for Quinaglute compared to Biquin and Quinidex.
    • The extent of absorption (AUC infinity) was similar across all three formulations.
    • Quinidex exhibited significantly greater mean steady-state trough concentrations and a much slower absorption rate compared to Biquin and Quinaglute.

    Conclusions:

    • While the overall extent of absorption is comparable, significant differences exist in the rate and peak concentrations of these sustained-release quinidine formulations.
    • Quinidex demonstrates slower absorption and higher trough levels, suggesting potential for prolonged absorption beyond the 12-hour dosing interval.
    • These pharmacokinetic variations necessitate careful consideration when selecting a sustained-release quinidine product for patient therapy.