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Related Experiment Videos

Comparative bioavailability of three commercial acetaminophen tablets

J B Sotiropoulus, T Deutsch, F M Plakogiannis

    Journal of Pharmaceutical Sciences
    |April 1, 1981
    PubMed
    Summary

    This study compared four acetaminophen products, finding significant variations in dissolution rates. Faster dissolution correlated with higher bioavailability, suggesting a link between in vitro properties and in vivo performance.

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    Area of Science:

    • Pharmaceutical Sciences
    • Pharmacokinetics
    • Drug Product Quality

    Background:

    • Acetaminophen is a widely used analgesic and antipyretic.
    • Variability in drug product quality can impact therapeutic efficacy.
    • In vitro dissolution testing is a key indicator of in vivo performance.

    Purpose of the Study:

    • To evaluate the in vitro properties and in vivo comparative bioavailability of four acetaminophen products.
    • To determine the relationship between dissolution rate and pharmacokinetic parameters.

    Main Methods:

    • Four acetaminophen products (three tablets, one liquid) were tested for in vitro properties (assay, hardness, friability, disintegration, dissolution).
    • In vivo comparative bioavailability was assessed using a urinary excretion experiment in four subjects with a crossover design.

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  • Dissolution rates were measured in 0.1 N HCl; elimination half-lives and relative bioavailabilities were calculated.

    • Main Results:

    • Significant variations in friability, disintegration, and dissolution were observed among the products.
    • Dissolution T50% values ranged from 1 min (Brands B, C) to 50 min (Brand A).
    • Relative bioavailabilities were 82% (A), 87% (B), and 92% (C); elimination half-lives varied.

    Conclusions:

    • In vitro dissolution rate appears to influence the rate and amount of acetaminophen excretion.
    • Product quality variations can lead to differences in acetaminophen bioavailability.
    • Dissolution testing is a valuable tool for predicting in vivo drug performance.