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Surface acidity of solid pharmaceutical excipients III. Excipients for solid dosage forms

C A Scheef1, D Oelkrug, P C Schmidt

  • 1Department of Pharmaceutical Technology, Eberhard Karl University, Tübingen, Germany.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|October 31, 1998
PubMed
Summary

This study quantifies surface acidity in pharmaceutical excipients using acid-base indicators and methanol. Particle size did not affect acidity measurements, providing reliable data for solid dosage form development.

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Area of Science:

  • Pharmaceutical Science
  • Analytical Chemistry

Background:

  • Surface acidity of pharmaceutical excipients is crucial for solid dosage form stability and performance.
  • Accurate quantification of surface acidity is essential for excipient selection and formulation development.

Purpose of the Study:

  • To quantify the surface acidity of pharmaceutical excipients using acid-base indicators.
  • To investigate the effect of particle size on surface acidity determination.
  • To present surface acidity data for common excipients used in solid dosage forms.

Main Methods:

  • Utilized acid-base indicators to detect surface acidity via color changes.
  • Employed methanol as an organic solvent to prepare indicator-excipient mixtures for hydrophilic excipients.
  • Investigated the influence of particle size on surface acidity measurements.

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Main Results:

  • Successfully quantified the indicator's transition interval on the surface of hydrophilic excipients.
  • Determined that particle size did not significantly influence surface acidity measurements within the tested range.
  • Provided quantitative surface acidity data for various common pharmaceutical excipients.

Conclusions:

  • The developed method reliably quantifies surface acidity of pharmaceutical excipients, independent of particle size.
  • The findings support the use of this method for characterizing excipients in solid dosage form development.
  • Surface acidity data presented can aid in rational excipient selection for improved drug product performance.