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Perspectives in solubility measurement and interpretation
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- Bergström, Christel A.S. 1973- (author)
- Uppsala universitet,Institutionen för farmaci
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- Avdeef, Alex (author)
- In ADME Res, 1732 First Ave,102, New York, NY 10128 USA
- (creator_code:org_t)
- 2019-04-03
- 2019
- English.
- In: ADMET AND DMPK. - : IAPC PUBLISHING. - 1848-7718. ; 7:2, s. 88-105
- Research review (peer-reviewed)
Abstract
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- Several key topics in solubility measurement and interpretation are briefly summarized and illustrated with case studies drawing on published solubility determinations as a function of pH. Featured are examples of ionizable molecules that exhibit solubility-pH curve distortion from that predicted by the traditionally used Henderson-Hasselbalch equation and possible interpretations for these distortions are provided. The scope is not exhaustive; rather it is focused on detailed descriptions of a few cases. Topics discussed are limitations of kinetic solubility, 'brick-dust and grease-balls,' applications of simulated and human intestinal fluids, supersaturation and the relevance of pre-nucleation clusters and sub-micellar aggregates in the formation of solids, drug-buffer/excipient complexation, hydrotropic solubilization, acid-base 'supersolubilization,' cocrystal route to supersaturation, as well as data quality assessment and solubility prediction. The goal is to highlight principles of solution equilibria - graphically more than mathematically - that could invite better assay design, to result in improved quality of measurements, and to impart a deeper understanding of the underlying solution chemistry in suspensions of drug solids. The value of solid state characterizations is stressed but not covered explicitly in this mini-review.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Hälsovetenskap -- Annan hälsovetenskap (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Health Sciences -- Other Health Sciences (hsv//eng)
Keyword
- Solubility-pH
- shake-flask solubility
- intrinsic solubility
- thermodynamic solubility
- Henderson-Hasselbalch equation
- supersaturation
- pre-nucleation clusters
- drug aggregates
- drug salts
- pharmaceutical cocrystals
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