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Related Experiment Videos

Bioavailability of controlled-release metoclopramide. 2nd communication: multiple dose study.

A H Beckett, W A Behrendt, B W Hadzija

    Arzneimittel-Forschung
    |February 1, 1987
    PubMed
    Summary

    Controlled-release metoclopramide capsules (Gastro-Timelets) and oral solution showed similar bioavailability in healthy men. Both formulations achieved bioequivalence, with smooth plasma concentration profiles for the capsules.

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    Area of Science:

    • Pharmacokinetics
    • Drug bioavailability
    • Pharmaceutical formulation

    Background:

    • Metoclopramide is commonly used for gastrointestinal motility disorders.
    • Understanding the bioavailability of different formulations is crucial for therapeutic efficacy.
    • Controlled-release formulations aim to provide sustained drug delivery.

    Purpose of the Study:

    • To compare the bioavailability of controlled-release metoclopramide capsules (Gastro-Timelets) versus an oral solution.
    • To assess the pharmacokinetic profile of metoclopramide after repeated oral administration.

    Main Methods:

    • A crossover study involving 10 healthy male subjects.
    • Administration of 30 mg of each metoclopramide formulation for 5 consecutive days.
    • Plasma metoclopramide concentrations measured using High-Performance Liquid Chromatography (HPLC).

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    Main Results:

    • Controlled-release capsules resulted in lower peak plasma metoclopramide levels occurring later compared to the solution.
    • Plasma concentration-time curves for the capsules were smoother, lacking sharp peaks and troughs.
    • Area Under the Curve (AUC) values indicated bioequivalence between the controlled-release capsules and the oral solution.

    Conclusions:

    • Controlled-release metoclopramide capsules (Gastro-Timelets) demonstrate bioequivalence to the oral solution.
    • The controlled-release formulation provides a smoother plasma concentration profile, potentially improving patient compliance and reducing side effects.
    • Both formulations are suitable for achieving therapeutic metoclopramide levels.