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Related Experiment Videos

pH-metric solubility. 3. Dissolution titration template method for solubility determination.

A Avdeef1, C M Berger

  • 1pION Inc., 5 Constitution Way, Woburn, MA 01801, USA. aavdeef@pion-inc.com

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
|October 31, 2001
PubMed
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This study introduces a faster potentiometric titration method for measuring drug solubility and pH profiles. The new protocol overcomes dissolution issues and significantly reduces data collection time.

Area of Science:

  • Pharmaceutical Science
  • Physical Chemistry
  • Analytical Chemistry

Background:

  • Determining aqueous solubility and solubility-pH profiles is crucial for ionizable drug development.
  • Traditional methods like shake-flask can be time-consuming and suffer from incomplete dissolution.
  • Developing efficient protocols is essential for accelerating drug discovery and formulation.

Purpose of the Study:

  • To develop a rapid and effective potentiometric saturation titration protocol.
  • To accurately determine aqueous intrinsic solubility and solubility-pH profiles of ionizable molecules.
  • To address challenges of incomplete dissolution and reduce experimental time.

Main Methods:

  • Application of modern dissolution kinetics theory (Noyes-Whitney extension) to acid-base titrations.

Related Experiment Videos

  • Development of a thermodynamic, three-component model for calculating concentrations in saturated solutions.
  • Utilizing potentiometric saturation titration with ten diverse drug compounds.

    • Main Results:

    • The developed method successfully determined solubility-pH profiles and intrinsic solubility.
    • The protocol effectively managed incomplete dissolution conditions during titration.
    • The new method demonstrated a tenfold increase in speed for determining equilibrium solubility constants compared to traditional methods.

    Conclusions:

    • The novel potentiometric saturation titration protocol offers a significantly faster and more robust approach for solubility determination.
    • This method provides a valuable tool for pharmaceutical scientists to efficiently characterize ionizable compounds.
    • The findings contribute to optimizing early-stage drug development processes.