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Stability study of nitroglycerin sublingual tablets

D P Page, N A Carson, C A Buhr

    Journal of Pharmaceutical Sciences
    |January 1, 1975
    PubMed
    Summary
    This summary is machine-generated.

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    Nitroglycerin sublingual tablets showed a decrease in strength over one year, but refrigeration helped maintain potency. Tablet uniformity and drug degradation remained stable during the study period.

    Area of Science:

    • Pharmaceutical Sciences
    • Drug Stability Studies

    Background:

    • Nitroglycerin sublingual tablets are crucial for managing angina.
    • Understanding the long-term stability of these tablets is essential for patient care.

    Purpose of the Study:

    • To evaluate the stability of nitroglycerin sublingual tablets over a one-year period.
    • To assess the impact of storage conditions on tablet strength, uniformity, and drug degradation.

    Main Methods:

    • Analysis of nitroglycerin tablets from six different manufacturers.
    • Semiautomated assay procedures to determine drug content and uniformity.
    • Inclusion of both molded and compressed tablet types with varying ages.

    Main Results:

    • A noticeable loss of nitroglycerin strength was observed in the tablets over time.

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  • Refrigeration significantly slowed down the rate of strength loss.
  • Tablet uniformity and the degradation of nitroglycerin itself remained within acceptable limits throughout the study.

    • Conclusions:

    • Nitroglycerin sublingual tablet strength degrades over time, emphasizing the need for proper storage.
    • Refrigeration is a key factor in preserving the potency of nitroglycerin tablets.
    • Despite strength loss, tablet uniformity and drug integrity are maintained, suggesting formulation stability.