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Bioavailability studies with Digoxin-Sandoz and Lanoxin.

T Beveridge, F Kalberer, E Nüesch

    European Journal of Clinical Pharmacology
    |June 13, 1975
    PubMed
    Summary
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    Digoxin bioavailability varies significantly between brands and batches. Digoxin-Sandoz demonstrated consistent bioavailability, similar to newer Lanoxin, but plasma data interpretation requires caution. Cumulative urinary excretion is the most reliable bioavailability measure.

    Area of Science:

    • Pharmacokinetics
    • Drug bioavailability studies

    Background:

    • Significant variations in digoxin tablet bioavailability exist across brands and batches.
    • This variability can impact therapeutic efficacy and patient safety.

    Purpose of the Study:

    • To compare the bioavailability of Digoxin-Sandoz tablets with Lanoxin.
    • To assess the impact of storage and batch variations on Digoxin-Sandoz bioavailability.
    • To evaluate the reliability of plasma concentration versus urinary excretion data for bioavailability assessment.

    Main Methods:

    • Three cross-over studies involving 20 volunteers.
    • Comparison of Digoxin-Sandoz with Lanoxin (1969-1972 and post-May 1972).
    • Analysis of bioavailability using plasma concentrations and cumulative urinary excretion data.

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    Main Results:

    • Digoxin-Sandoz exhibited constant bioavailability, comparable to "new" Lanoxin.
    • Two-year storage did not affect Digoxin-Sandoz bioavailability.
    • Particle size influenced bioavailability.
    • Plasma data interpretation up to 6 hours post-administration can overestimate bioavailability differences compared to cumulative urinary excretion data.

    Conclusions:

    • Digoxin-Sandoz offers reliable bioavailability.
    • Cumulative urinary excretion over extended periods is the most dependable method for assessing digoxin bioavailability.
    • Caution is advised when relying solely on short-term plasma data for bioavailability assessment.