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Related Experiment Videos

Relative bioavailability of acetazolamide tablets

A B Straughn, R Gollamudi, M C Meyer

    Biopharmaceutics & Drug Disposition
    |January 1, 1982
    PubMed
    Summary

    Different acetazolamide tablet formulations showed variations in absorption rates, impacting peak plasma concentrations. In vitro dissolution testing correlated with these in vivo absorption differences, crucial for drug product quality.

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    Area of Science:

    • Pharmacokinetics
    • Drug product analysis
    • Bioavailability studies

    Background:

    • Acetazolamide is a carbonic anhydrase inhibitor used to treat glaucoma and epilepsy.
    • Variability in drug product performance can affect therapeutic outcomes.
    • Understanding in vivo absorption differences between dosage forms is critical for patient safety.

    Purpose of the Study:

    • To compare plasma acetazolamide concentrations from different tablet dosage forms.
    • To investigate the correlation between in vitro dissolution and in vivo absorption rates.
    • To assess the impact of different manufacturing lots on drug product performance.

    Main Methods:

    • A crossover study involving 12 human subjects.
    • Enzymatic determination of plasma acetazolamide concentrations.
    • In vitro dissolution testing at pH 1.5.

    Main Results:

    • No significant differences in overall drug exposure (AUC) were observed across treatments.
    • Significant differences in peak plasma concentration (Cmax) and time to peak concentration (Tmax) were found.
    • In vitro dissolution data correlated with in vivo absorption rate differences.

    Conclusions:

    • While overall bioavailability was similar, tablet formulations exhibited different absorption kinetics.
    • In vitro dissolution at pH 1.5 can predict in vivo absorption rate differences.
    • Manufacturing processes or formulation excipients may influence acetazolamide absorption rate.

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