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Related Experiment Videos

Isosorbide 5-mononitrate kinetics.

R M Major, T Taylor, L F Chasseaud

    Clinical Pharmacology and Therapeutics
    |May 1, 1984
    PubMed
    Summary
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    Isosorbide 5-mononitrate (5-ISMN) exhibits favorable pharmacokinetics, including complete oral absorption and a long half-life. This makes 5-ISMN a reliable vasodilator organic nitrate with predictable dosing for patients.

    Area of Science:

    • Pharmacology
    • Clinical Pharmacy
    • Drug Metabolism

    Background:

    • Organic nitrates are widely used as vasodilators.
    • Understanding the pharmacokinetics of isosorbide 5-mononitrate (5-ISMN) is crucial for optimizing its therapeutic use.
    • Previous studies have indicated potential variability in the absorption and metabolism of organic nitrates.

    Purpose of the Study:

    • To characterize the pharmacokinetic profile of isosorbide 5-mononitrate (5-ISMN) in healthy subjects.
    • To compare the kinetics of 5-ISMN following intravenous and oral administration.
    • To evaluate the absorption, distribution, metabolism, and excretion (ADME) characteristics of 5-ISMN.

    Main Methods:

    • A pharmacokinetic study involving 12 healthy subjects.
    • Intravenous infusion and oral administration of 20 mg isosorbide 5-mononitrate (5-ISMN).

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  • Model-independent and one-compartment open model analyses were used to determine kinetic parameters.

    • Main Results:

    • Isosorbide 5-mononitrate (5-ISMN) demonstrated excellent oral absorption (93% systemic availability) with rapid peak plasma concentrations at 0.83 hours.
    • Key pharmacokinetic parameters included a systemic clearance of 127 ml/min, volume of distribution of 48.5 L, and a half-life (t 1/2) of 4.4 hours.
    • Low intersubject variability in kinetics was observed, distinguishing 5-ISMN from other organic nitrates.

    Conclusions:

    • Isosorbide 5-mononitrate (5-ISMN) possesses a favorable pharmacokinetic profile characterized by complete oral absorption, a relatively long half-life, and minimal intersubject variability.
    • These pharmacokinetic properties suggest predictable therapeutic efficacy and simplified dosing regimens for 5-ISMN.
    • The absence of active metabolites further enhances the safety and predictability of isosorbide 5-mononitrate (5-ISMN) therapy.