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Related Experiment Videos

Elementary osmotic pump for indomethacin.

F Theeuwes, D Swanson, P Wong

    Journal of Pharmaceutical Sciences
    |March 1, 1983
    PubMed
    Summary
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    New osmotic pump systems deliver indomethacin at controlled rates. In vitro testing accurately predicts in vivo drug delivery performance in dogs, offering a promising alternative to conventional capsules.

    Area of Science:

    • Pharmacology
    • Drug Delivery Systems
    • Biopharmaceutics

    Background:

    • Osmotic pump systems offer controlled drug release.
    • Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID).
    • Optimizing drug delivery is crucial for therapeutic efficacy.

    Purpose of the Study:

    • To design and evaluate novel osmotic pump systems for controlled indomethacin delivery.
    • To assess the in vitro performance and in vivo predictability of these systems.
    • To compare the pharmacokinetic profiles with conventional indomethacin capsules.

    Main Methods:

    • Development of three osmotic pump prototypes with varying delivery rates (Z), total drug content (Mt), and 80% delivery time (t80).
    • In vitro drug release studies under different conditions (pH, stirring rate).

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  • In vivo drug delivery evaluation in canine gastrointestinal tracts.
  • Analysis of urinary drug recovery and plasma concentration profiles in human volunteers.

    • Main Results:

    • All systems demonstrated zero-order drug release, delivering approximately 70% of the indomethacin content.
    • Drug release rates were consistent and unaffected by pH, measurement method, or stirring rate.
    • In vitro release rates correlated well with in vivo performance in dogs, validating the in vitro method.
    • Human volunteer studies showed similar urinary recoveries but distinct plasma profiles compared to conventional capsules.

    Conclusions:

    • The developed osmotic pump systems provide predictable, zero-order indomethacin release.
    • The in vitro testing method is bioanalogous and predictive of in vivo drug delivery.
    • These novel systems represent a potentially improved alternative to conventional indomethacin formulations.