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Dissolution test for silymarin tablets and capsules.

A Campodónico1, E Collado, R Ricci

  • 1Cátedra de Control de Calidad de Medicamentos, Facultad de Farmacia y Bioquímica, Universidad de Buenos Aires, Junín 956, (1113) Buenos Aires, Argentina.

Drug Development and Industrial Pharmacy
|April 9, 2001
PubMed
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A new dissolution test estimates silymarin (Sl) in pharmaceutical products derived from Silybum marianum. The method shows reliable results, with dissolved silymarin ranging from 50-90% of labeled amounts in tested formulations.

Area of Science:

  • Pharmacognosy and Pharmaceutical Sciences
  • Phytochemistry
  • Analytical Chemistry

Background:

  • Silybum marianum contains active flavonoids like silybine, isosilybine, silycristine, and silydianine, collectively known as silymarin (Sl).
  • Accurate quantification of silymarin in pharmaceutical formulations is crucial for therapeutic efficacy.
  • Existing methods may require complex procedures for silymarin content estimation.

Purpose of the Study:

  • To develop and validate a simple dissolution test for estimating silymarin content in pharmaceutical formulations.
  • To assess the performance of commercial silymarin products from different geographical origins.

Main Methods:

  • Development of a straightforward dissolution test protocol.
  • Analysis of five commercial pharmaceutical products (tablets, sugar tablets, capsules) from Argentina, Brazil, Spain, and Italy.

Related Experiment Videos

  • Quantification of silymarin using high-performance liquid chromatography (HPLC) and UV spectrophotometry.

    • Main Results:

    • The developed dissolution test provides estimates of silymarin content in pharmaceutical formulations.
    • Dissolved silymarin amounts ranged from 50% to 90% of the labeled value, contingent on dosage form disintegration.
    • The method demonstrated feasibility across various commercial products and international sources.

    Conclusions:

    • A simple dissolution test is effective for estimating silymarin content in Silybum marianum-based pharmaceutical products.
    • The test's accuracy is dependent on the disintegration properties of the dosage form.
    • This method offers a practical approach for quality control of silymarin formulations.