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Related Experiment Videos

Is bicarbonate buffer suitable as a dissolution medium?

Julia Elisabeth Boni1, Rolf Stefan Brickl, Jennifer Dressman

  • 1Pharmaceutical Research & Development, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany.

The Journal of Pharmacy and Pharmacology
|October 4, 2007
PubMed
Summary
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Preparing bicarbonate buffer for drug dissolution testing is time-consuming and yields less reproducible results compared to standard phosphate buffers. Its physiological relevance is limited by practical challenges in dissolution studies.

Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery
  • Biopharmaceutical Analysis

Background:

  • Bicarbonate buffer systems are physiologically relevant for simulating intestinal conditions.
  • Standard phosphate buffers and biorelevant media like FaSSIF are commonly used in dissolution testing.
  • Evaluating alternative buffer systems is crucial for improving dissolution testing methods.

Purpose of the Study:

  • To compare the preparation of bicarbonate buffer with standard methods.
  • To assess the suitability of bicarbonate buffer for drug dissolution testing.
  • To compare dissolution profiles of a Biopharmaceutical Classification System Class II drug (BIXX) in various media.

Main Methods:

  • Two methods for bicarbonate buffer preparation were compared.

Related Experiment Videos

  • Dissolution testing of three BIXX formulations was conducted in bicarbonate buffer, phosphate buffer, and fasted-state simulating intestinal fluid (FaSSIF).
  • Media preparation ease, robustness, and reproducibility were evaluated.

    • Main Results:

    • Bicarbonate buffer preparation was time-consuming and required in-situ preparation with constant CO2 supply for pH stability.
    • Dissolution testing in bicarbonate buffer showed 1.5- to 5-times higher coefficients of variance compared to phosphate buffers.
    • Reproducibility of dissolution results was poorer with bicarbonate buffer.

    Conclusions:

    • While physiologically relevant for the fasted state, bicarbonate buffer's practicality for dissolution testing is limited.
    • The poor reproducibility of results restricts the suitability of bicarbonate buffer for routine dissolution testing.
    • Phosphate buffers remain a more robust and reproducible choice for compendial media and FaSSIF preparation.