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Related Experiment Videos

Bioavailability and dissolution behavior of trisulfapyrimidine suspensions.

L K Mathur, J M Jaffe, R I Poust

    Journal of Pharmaceutical Sciences
    |June 1, 1979
    PubMed
    Summary

    This study compared the bioavailability of seven trisulfapyrimidine suspensions in humans. An in vitro dissolution method showed promise for screening these drug suspensions, correlating well with in vivo results.

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    Area of Science:

    • Pharmacokinetics and Drug Bioavailability
    • Pharmaceutical Sciences
    • Analytical Chemistry

    Background:

    • Trisulfapyrimidine suspensions are commonly used for their antibacterial properties.
    • Variability in commercial formulations can impact drug efficacy.
    • Standardized methods are needed to ensure consistent drug delivery.

    Purpose of the Study:

    • To evaluate the in vivo bioavailability of seven commercial trisulfapyrimidine suspensions.
    • To assess the in vitro dissolution characteristics of these suspensions.
    • To establish a correlation between in vitro dissolution and in vivo bioavailability for quality control.

    Main Methods:

    • Seven commercial trisulfapyrimidine suspensions were administered to 14 healthy adult male volunteers (1-g dose).

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  • Serum drug concentrations (sulfadiazine, sulfamerazine, sulfamethazine) were measured over 48 hours using high-pressure liquid chromatography (HPLC).
  • In vitro dissolution testing was performed using the FDA paddle method in hydrochloric acid at 37°C, with samples analyzed by HPLC.

    • Main Results:

    • Significant differences in pharmacokinetic parameters (Cmax, Tmax, AUC) were observed among the seven trisulfapyrimidine suspensions.
    • In vitro dissolution studies revealed variations in the dissolution rates of the commercial preparations.
    • A significant positive correlation was found between an in vivo parameter (Cmax for sulfadiazine) and an in vitro parameter (percent sulfadiazine dissolved in 30 minutes).

    Conclusions:

    • Commercial trisulfapyrimidine suspensions exhibit significant variability in bioavailability.
    • The in vitro dissolution method using the FDA paddle method is a suitable and reliable tool for screening trisulfapyrimidine suspensions.
    • This in vitro method can help ensure consistent drug product quality and predict in vivo performance.