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Related Experiment Videos

USP dissolution test II: Sigmoid dissolution profiles from directly compressed tablets.

J T Carstensen, J L Wright, K W Blessel

    Journal of Pharmaceutical Sciences
    |January 1, 1978
    PubMed
    Summary

    This study models tablet dissolution, explaining sigmoid dissolution curves and the log-linear relationship observed after the lag time in dissolution testing.

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    Area of Science:

    • Pharmaceutical Sciences
    • Physical Chemistry

    Background:

    • Understanding drug release kinetics is crucial for pharmaceutical development.
    • Directly compressed tablets are a common dosage form, requiring robust dissolution profiles.
    • The United States Pharmacopeia (USP) basket apparatus is a standard method for dissolution testing.

    Purpose of the Study:

    • To investigate the fundamental steps governing the dissolution of directly compressed tablets.
    • To develop a model that explains the characteristic sigmoid shape of dissolution curves.
    • To elucidate the correlation between undissolved mass and time beyond the initial lag phase.

    Main Methods:

    • Data generation was employed to analyze tablet dissolution.
    • A mathematical model was proposed to describe the dissolution process.

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  • The study focused on dissolution within a USP basket apparatus.

    • Main Results:

    • The proposed model successfully explains the sigmoid shape of dissolution curves.
    • A log-linear correlation between undissolved mass and time was identified post-lag time.
    • The model provides insights into the physical processes occurring during tablet disintegration and dissolution.

    Conclusions:

    • The developed model offers a comprehensive understanding of directly compressed tablet dissolution.
    • This research contributes to predicting and optimizing drug release profiles.
    • The findings are relevant for pharmaceutical formulation and quality control.