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PH-dependent drug release from certain commercial tablets.

J E Sutton, J L Lach, R S Wagner

    American Journal of Hospital Pharmacy
    |December 1, 1977
    PubMed
    Summary
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    Dissolution testing of nitrofurantoin and sulfisoxazole tablets revealed significant brand-to-brand variability and unpredictable pH effects. Standard single-pH dissolution tests may be inadequate for these drugs, impacting formulation considerations.

    Area of Science:

    • Pharmaceutical Sciences
    • Drug Delivery
    • Physical Pharmacy

    Background:

    • Drug dissolution is critical for oral bioavailability.
    • pH-dependent drug release can impact therapeutic efficacy.
    • Standard dissolution testing protocols may not capture complex release profiles.

    Purpose of the Study:

    • To develop dissolution-dialysis profiles for nitrofurantoin, hydrochlorothiazide, and sulfisoxazole tablets at various pH levels.
    • To assess the impact of pH on drug release rates.
    • To evaluate the adequacy of single-pH dissolution testing.

    Main Methods:

    • Utilized a two-compartment diffusion cell with a semipermeable cellophane membrane.
    • Tested nitrofurantoin and sulfisoxazole tablets across a range of pH values (1.2 to 7.2).

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  • Hydrochlorothiazide studies were discontinued due to negligible pH effects.

    • Main Results:

    • Dissolution rates for nitrofurantoin and sulfisoxazole were highly brand-specific and complex.
    • The influence of pH on drug release was unpredictable for these formulations.
    • Hydrochlorothiazide dissolution was not significantly affected by pH.

    Conclusions:

    • Single-point pH dissolution testing may be insufficient for certain drug products like nitrofurantoin and sulfisoxazole.
    • Formulators must consider pH-dependent release characteristics.
    • Unpredictable pH effects on dissolution warrant careful consideration in drug product development.