pH-Induced precipitation behavior of weakly basic compounds: determination of extent and duration of supersaturation using potentiometric titration and correlation to solid state properties.

Pharmaceutical Research
Yi-Ling HsiehLynne S Taylor

Abstract

To examine the precipitation and supersaturation behavior of ten weak bases in terms of the relationship between pH-concentration-time profiles and the solid state properties of the precipitated material. Initially the compound was dissolved at low pH, followed by titration with base to induce precipitation. Upon precipitation, small aliquots of acid or base were added to induce slight subsaturation and supersaturation respectively and the resultant pH gradient was determined. The concentration of the unionized species was calculated as a function of time and pH using mass and charge balance equations. Two patterns of behavior were observed in terms of the extent and duration of supersaturation arising following an increase in pH and this behavior could be rationalized based on the crystallization tendency of the compound. For compounds that did not readily crystallize, an amorphous precipitate was formed and a prolonged duration of supersaturation was observed. For compounds that precipitated to crystalline forms, the observed supersaturation was short-lived. This study showed that supersaturation behavior has significant correlation with the solid-state properties of the precipitate and that pH-metric titration methods can be...Continue Reading

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Citations

Aug 26, 2014·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Asami Ono, Kiyohiko Sugano
Sep 10, 2014·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Mark BerlinJennifer B Dressman
Feb 12, 2014·Journal of Pharmaceutical Sciences·Cordula StillhartMartin Kuentz
Jan 3, 2014·Journal of Pharmaceutical Sciences·Shweta A RainaLynne S Taylor
Apr 10, 2013·Journal of Pharmaceutical Sciences·Panos MacherasGeorgia Valsami
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May 29, 2015·Pharmaceutical Research·Shweta A RainaLynne S Taylor
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Sep 17, 2019·Molecular Pharmaceutics·Enikő BorbásHajnalka Pataki

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