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Bioavailability of a sustained-release dyphylline formulation

K J Simons, F E Simons, C W Bierman

    Journal of Clinical Pharmacology
    |April 1, 1977
    PubMed
    Summary
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    Sustained-release dyphylline tablets offer lower bioavailability but maintain therapeutic serum concentrations. This study found no adverse effects in subjects receiving multiple doses of sustained-release dyphylline.

    Area of Science:

    • Pharmacokinetics and Drug Delivery

    Background:

    • Dyphylline is a bronchodilator used in respiratory conditions.
    • Optimizing drug delivery systems is crucial for effective therapeutic outcomes.

    Purpose of the Study:

    • To evaluate the bioavailability of dyphylline from sustained-release (SR) tablets compared to conventional tablets.
    • To assess the pharmacokinetic profile and safety of multiple-dose dyphylline SR tablets.

    Main Methods:

    • Single-dose bioavailability study in seven healthy subjects comparing dyphylline SR tablets to conventional tablets.
    • Multiple-dose pharmacokinetic study in three subjects receiving dyphylline SR tablets every 8 hours for four days.
    • Serum dyphylline concentrations were monitored to determine bioavailability and steady-state levels.

    Main Results:

    Related Experiment Videos

    • Bioavailability of dyphylline from SR tablets was 67.8% relative to conventional tablets.
    • Multiple dosing achieved steady-state serum dyphylline concentrations above 7.88 microng/ml.
    • Peak serum concentrations reached 30 microng/ml in one subject with no reported adverse effects.

    Conclusions:

    • Dyphylline SR tablets demonstrate reduced bioavailability but can achieve and maintain therapeutic serum concentrations.
    • The multiple-dose regimen of dyphylline SR tablets appears safe and effective for maintaining therapeutic levels.