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Related Experiment Videos

Digoxin degradation in acidic dissolution medium

T Sonobe, S Hasumi, T Yoshino

    Journal of Pharmaceutical Sciences
    |April 1, 1980
    PubMed
    Summary

    Digoxin tablets showed faster release in water and artificial intestinal juice. In USP dissolution tests, hydrolysis was significant, but magnesium compounds in formulations effectively suppressed digoxin breakdown without delaying release.

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    Area of Science:

    • Pharmaceutical Sciences
    • Drug Delivery
    • Analytical Chemistry

    Background:

    • Digoxin is a cardiac glycoside with a narrow therapeutic index, necessitating precise control over its release and stability.
    • Understanding digoxin's degradation pathways in dissolution media is crucial for accurate pharmaceutical quality control.
    • Two manufacturing methods, solvent deposition and simple blending, were compared for digoxin tablet formulations.

    Purpose of the Study:

    • To investigate the dissolution and degradation kinetics of digoxin from two tablet formulations (A and B) in various media.
    • To elucidate the hydrolysis products and rates of digoxin degradation in a United States Pharmacopeia (USP) dissolution test medium.
    • To explore formulation strategies for inhibiting digoxin hydrolysis during dissolution testing.

    Main Methods:

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    • High-performance liquid chromatography (HPLC) was employed to quantify digoxin and its hydrolysis products.
    • Dissolution testing was performed using distilled water, artificial intestinal juice, and a USP dissolution test medium.
    • Differential equations were used to model the concentrations of digoxin and its degradation products based on dissolution and hydrolysis rates.

    Main Results:

    • Tablet A (solvent deposition) exhibited faster digoxin release than Tablet B (simple blending) in water and artificial intestinal juice, with no observed decomposition.
    • In the USP dissolution medium, digoxin underwent hydrolysis to digoxigenin bisdigitoxoside, digoxigenin monodigitoxoside, and digoxigenin.
    • Hydrolysis was the rate-determining step in the early stage of dissolution, while dissolution became rate-limiting in the later stage of digoxin degradation.
    • Incorporating magnesium oxide or magnesium hydroxide-aluminum hydroxide into tablet formulations inhibited digoxin hydrolysis by over 14% within 30 minutes without significantly delaying drug release.

    Conclusions:

    • Digoxin's stability is formulation and medium-dependent, with significant hydrolysis occurring in the USP dissolution test medium.
    • The rate-determining step for digoxin degradation shifts from hydrolysis to dissolution over time.
    • Magnesium-based excipients offer a viable strategy to mitigate digoxin hydrolysis during dissolution testing, improving assay reliability.