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Bioavailability of sustained release propranolol formulations

J McAinsh, N S Baber, B F Holmes

    Biopharmaceutics & Drug Disposition
    |January 1, 1981
    PubMed
    Summary

    This study compared sustained-release propranolol formulations to a conventional tablet. Sustained-release propranolol showed longer half-lives and higher blood levels, indicating improved bioavailability.

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    Area of Science:

    • Pharmacokinetics
    • Drug formulation
    • Bioavailability studies

    Background:

    • Propranolol is a beta-blocker used to treat various cardiovascular conditions.
    • Optimizing propranolol delivery systems is crucial for therapeutic efficacy.
    • Sustained-release formulations aim to provide prolonged drug levels and reduce dosing frequency.

    Purpose of the Study:

    • To compare the bioavailability of two sustained-release propranolol formulations ('Inderal' LA and a clinical trial formulation) against a conventional 'Inderal' tablet.
    • To assess the impact of dissolution rate on propranolol pharmacokinetics.
    • To evaluate the in vivo performance of different propranolol delivery systems.

    Main Methods:

    • A crossover study involving twelve healthy adult male volunteers.

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  • Administration of 160 mg oral doses of three 'Inderal' formulations on separate occasions.
  • Measurement of propranolol concentrations in whole blood to determine bioavailability.

    • Main Results:

    • Peak blood levels and area under the curve decreased with increased dissolution time.
    • Sustained-release formulations exhibited longer half-lives compared to the conventional tablet.
    • Both sustained-release formulations maintained higher blood levels over 24 hours than the conventional tablet, with 'Inderal' LA showing superior results.

    Conclusions:

    • Increased dissolution time correlates with lower systemic bioavailability of propranolol.
    • Sustained-release propranolol formulations offer advantages in maintaining therapeutic drug levels.
    • The observed decrease in bioavailability with longer dissolution times may be attributed to increased propranolol metabolism.