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Clodronate kinetics and bioavailability.

G J Yakatan, W J Poynor, R L Talbert

    Clinical Pharmacology and Therapeutics
    |March 1, 1982
    PubMed
    Summary
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    Carbon 13-labeled clodronate disodium (Cl2MDP) is poorly absorbed orally, with only 1-2% bioavailability. The drug is primarily excreted unchanged by the kidneys, with a significant portion eliminated within 48 hours post-intravenous administration.

    Area of Science:

    • Pharmacokinetics and Drug Metabolism
    • Nephrology and Renal Excretion
    • Isotope Tracing in Biological Systems

    Background:

    • Clodronate disodium (Cl2MDP) is a bisphosphonate used in treating bone diseases.
    • Understanding its absorption, distribution, metabolism, and excretion (ADME) is crucial for optimizing therapeutic use.
    • Previous studies have indicated varying absorption rates, necessitating detailed pharmacokinetic analysis.

    Purpose of the Study:

    • To characterize the pharmacokinetic profile of carbon 13-labeled clodronate disodium in healthy adult males.
    • To determine the absorption, excretion, and disposition kinetics following intravenous and oral administration.
    • To quantify the absolute bioavailability of orally administered clodronate disodium.

    Main Methods:

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  • A crossover study design was employed in healthy adult males.
  • Carbon 13-labeled clodronate disodium was administered via intravenous infusion and orally.
  • Serum and urine clodronate levels were quantified over time using isotope-ratio mass spectrometry.

    • Main Results:

    • Clodronate disodium is primarily excreted unchanged by the kidney, with over 80% recovered within 48 hours after IV dosing.
    • Intravenous administration showed a biexponential serum concentration-time curve with a disposition half-life of 2 hours.
    • Oral bioavailability was found to be very low, ranging from 1% to 2%.

    Conclusions:

    • Clodronate disodium exhibits poor oral absorption and is predominantly eliminated renally in an unchanged form.
    • The drug's disposition kinetics are complex, potentially triexponential, though a slower component is less significant after a single dose.
    • These findings highlight the importance of the intravenous route for clodronate disodium administration due to its limited oral bioavailability.