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Related Experiment Videos

Serious bioavailability problems with a generic prolonged-release quinidine gluconate product

M C Meyer, A B Straughn, P Lieberman

    Journal of Clinical Pharmacology
    |February 1, 1982
    PubMed
    Summary

    A new quinidine gluconate tablet showed significantly lower absorption compared to the original. This bioequivalence issue led to a Class I recall by the U.S. Food and Drug Administration.

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    Area of Science:

    • Pharmacokinetics and Drug Bioavailability
    • Pharmaceutical Sciences
    • Clinical Pharmacology

    Background:

    • A new prolonged-release quinidine gluconate tablet formulation was recently introduced to the market.
    • Quinidine is an antiarrhythmic medication requiring consistent therapeutic drug levels.
    • Bioequivalence studies are crucial for ensuring therapeutic equivalence between generic and innovator drug products.

    Purpose of the Study:

    • To compare the bioavailability of a new prolonged-release quinidine gluconate tablet against the innovator product.
    • To assess potential bioequivalence issues with the new quinidine formulation.
    • To evaluate the clinical implications of any observed differences in drug absorption.

    Main Methods:

    • A single-dose, open-label bioavailability study was conducted.

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  • Twelve healthy adult male subjects participated in the study.
  • Plasma concentrations of quinidine were measured after administration of both tablet formulations.

    • Main Results:

    • The extent of quinidine absorption from the new marketed product was approximately 50% of that from the innovator's product.
    • Projections indicated significantly lower steady-state plasma concentrations for the new formulation during multiple-dose administration.
    • A bioequivalence problem with medically significant implications was identified.

    Conclusions:

    • The new prolonged-release quinidine gluconate tablet exhibited suboptimal bioavailability compared to the innovator product.
    • The observed pharmacokinetic differences pose a risk to therapeutic efficacy and patient safety.
    • The study's findings directly led to a Class I recall of the less bioavailable quinidine product by the U.S. Food and Drug Administration.