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Spironolactone. II. Bioavailability.

A Karim, J Zagarella, T C Hutsell

    Clinical Pharmacology and Therapeutics
    |February 1, 1976
    PubMed
    Summary
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    This study compared spironolactone bioavailability from tablets versus a solution. New 100-mg spironolactone tablets showed similar bioavailability to existing 25-mg tablets, but urinary canrenone excretion is not a reliable measure.

    Area of Science:

    • Pharmacokinetics
    • Drug bioavailability
    • Metabolism studies

    Background:

    • Spironolactone is a widely used medication.
    • Assessing the bioavailability of different spironolactone formulations is crucial for therapeutic efficacy.
    • Previous studies have investigated spironolactone's absorption and metabolism.

    Purpose of the Study:

    • To determine and compare the bioavailability of commercial 25-mg spironolactone tablets and a new 100-mg tablet formulation.
    • To evaluate the pharmacokinetic profile of spironolactone and its metabolite canrenone.
    • To assess the reliability of urinary canrenone excretion as a bioavailability indicator.

    Main Methods:

    • 12 healthy male subjects received a 200-mg oral dose of spironolactone in solution or tablet form.

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  • Plasma levels of canrenone (dethioacetylated metabolite) were measured over time.
  • Area under the plasma concentration-time curve (AUC) was calculated to determine bioavailability.
  • Urinary excretion of canrenone was quantified over 48 hours.

    • Main Results:

    • Peak plasma canrenone levels were higher and reached faster with the solution compared to both tablet formulations.
    • Bioavailability of the 25-mg and 100-mg tablets relative to the solution was approximately 99.6% and 92.1%, respectively.
    • Urinary canrenone excretion represented only 2% to 4% of the administered dose and varied between formulations.

    Conclusions:

    • Both 25-mg and 100-mg spironolactone tablet formulations exhibit comparable bioavailability.
    • Urinary canrenone excretion is not a dependable method for assessing spironolactone bioavailability due to low recovery and formulation-dependent variability.