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Developing a discriminating dissolution test for three mebendazole polymorphs based on solubility differences.

E Swanepoel1, W Liebenberg, B Devarakonda

  • 1Research Institute for Industrial Pharmacy, School of Pharmacy, Potchefstroom University for CHE, Potchefstroom, South Africa.

Die Pharmazie
|March 19, 2003
PubMed
Summary
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Mebendazole dissolution testing requires careful medium selection. Reducing sodium lauryl sulphate (SLS) in hydrochloric acid (HCl) dissolution media enhances sensitivity to mebendazole

Area of Science:

  • Pharmaceutical Sciences
  • Physical Chemistry

Background:

  • Mebendazole, a broad-spectrum anthelmintic, exhibits poor water solubility and exists in three polymorphic forms (A, B, C).
  • Pharmaceutical development requires dissolution tests sensitive to drug crystal form, as it impacts drug release from oral dosage forms.
  • The United States Pharmacopeia (USP) 24 specifies a dissolution medium of 0.1 M hydrochloric acid (HCl) with 1.0% sodium lauryl sulphate (SLS) for mebendazole tablets.

Purpose of the Study:

  • To investigate the impact of sodium lauryl sulphate (SLS) concentration on the ability of dissolution media to differentiate between mebendazole polymorphs.
  • To identify an optimized dissolution medium composition for discriminating the solubility differences of mebendazole's polymorphic forms.

Main Methods:

  • Dissolution testing of mebendazole polymorphs (A, B, C) using varying concentrations of sodium lauryl sulphate (SLS) in 0.1 M hydrochloric acid (HCl).

Related Experiment Videos

  • Comparison of dissolution profiles generated with the standard USP 24 medium versus modified media with reduced SLS content.

    • Main Results:

    • The standard USP 24 dissolution medium (0.1 M HCl with 1.0% SLS) failed to distinguish between the dissolution rates of mebendazole polymorphs.
    • Decreasing the SLS concentration in the dissolution medium revealed significant differences in the dissolution rates among the three mebendazole polymorphs.
    • The most effective medium for discriminating between mebendazole polymorphs was 0.1 M HCl without any added SLS.

    Conclusions:

    • The high SLS concentration in the current USP dissolution test for mebendazole masks critical differences in polymorph solubility.
    • Optimizing dissolution media composition, specifically by reducing or eliminating SLS, is crucial for developing tests that are sensitive to mebendazole's polymorphic variations.
    • A dissolution medium of 0.1 M HCl alone provides superior discrimination between mebendazole polymorphs, aiding in pharmaceutical development and quality control.