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Bioavailability of acetazolamide tablets.

G J Yakatan, E L Frome, R G Leonard

    Journal of Pharmaceutical Sciences
    |February 1, 1978
    PubMed
    Summary
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    Bioequivalence of acetazolamide tablets was assessed. While most bioavailability parameters were similar, two lots showed higher peak plasma concentrations, indicating lot-to-lot bioinequivalence.

    Area of Science:

    • Pharmacokinetics
    • Pharmaceutical Sciences
    • Drug Bioavailability

    Background:

    • Acetazolamide is a carbonic anhydrase inhibitor with therapeutic applications.
    • Ensuring consistent drug product quality is crucial for patient safety and efficacy.
    • Variability in drug manufacturing can lead to differences in bioavailability.

    Purpose of the Study:

    • To evaluate the lot-to-lot bioequivalence of acetazolamide tablets from a single manufacturer.
    • To assess key pharmacokinetic parameters including AUC, Tmax, and Cmax.
    • To explore the correlation between in vitro tests and in vivo bioavailability.

    Main Methods:

    • A single oral dose of 250 mg acetazolamide was administered to 20 healthy volunteers.
    • Five different lots of acetazolamide tablets were tested using a balanced incomplete block design.

    Related Experiment Videos

  • Plasma acetazolamide levels were quantified using an enzymatic assay.
  • Bioavailability parameters were calculated using digital computer fitting of plasma concentration-time data.

    • Main Results:

    • No significant differences were found in the area under the curve (AUC) or time to peak plasma concentration (Tmax) among the tested acetazolamide tablet lots.
    • Two of the five tested lots exhibited statistically significant higher peak plasma concentrations (Cmax) compared to the other three lots.
    • Lot-to-lot bioinequivalence was confirmed for acetazolamide tablets based on Cmax.

    Conclusions:

    • Significant lot-to-lot bioinequivalence exists among acetazolamide tablets from the same manufacturer, primarily due to differences in peak plasma concentrations.
    • In vitro tests showed some correlation with in vivo data but require further refinement for accurate prediction of bioinequivalence.
    • Manufacturing processes need careful control to ensure consistent acetazolamide tablet quality and therapeutic performance.