Characterization of solid excipients: delving deeper by probing the surface

Performance differences in different lots of solid excipients often cannot be detected by bulk physicochemical methods. This is because some of these (performance) differences originate at the surface of individual excipient particles, accounting for attributes that comprise a disproportionately lar...

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Main Author: Shireesh Apte
Format: Article
Language:English
Published: International Pharmaceutical Excipients Council 2016-11-01
Series:Journal of Excipients and Food Chemicals
Online Access:https://jefc.scholasticahq.com/article/1128-characterization-of-solid-excipients-delving-deeper-by-probing-the-surface
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author Shireesh Apte
author_facet Shireesh Apte
author_sort Shireesh Apte
collection DOAJ
description Performance differences in different lots of solid excipients often cannot be detected by bulk physicochemical methods. This is because some of these (performance) differences originate at the surface of individual excipient particles, accounting for attributes that comprise a disproportionately large part of the surface but a very small fraction of the total amount of the material. Because surface interactions play a significant role in the formulation and stability of solid dosage forms, it should not be surprising that excipients that may be indistinguishable at the compendial, and/or bulk level, may yet behave differently due to their different surface characteristics. Surface acidity, surface free energy, surface charge, surface roughness and surface amorphicity (crystallinity) of a bulk excipient powder represent attributes that are not usually measured as part of routine raw material testing by the end user. In addition to the apparent values of these surface characteristics, their intra- and inter-lot heterogeneity can influence functionality, and in some instances, significantly cause it to change.
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spelling doaj.art-825bac314c2441af81cdeac1f1271e6c2024-03-20T18:01:27ZengInternational Pharmaceutical Excipients CouncilJournal of Excipients and Food Chemicals2150-26682016-11-0121Characterization of solid excipients: delving deeper by probing the surfaceShireesh AptePerformance differences in different lots of solid excipients often cannot be detected by bulk physicochemical methods. This is because some of these (performance) differences originate at the surface of individual excipient particles, accounting for attributes that comprise a disproportionately large part of the surface but a very small fraction of the total amount of the material. Because surface interactions play a significant role in the formulation and stability of solid dosage forms, it should not be surprising that excipients that may be indistinguishable at the compendial, and/or bulk level, may yet behave differently due to their different surface characteristics. Surface acidity, surface free energy, surface charge, surface roughness and surface amorphicity (crystallinity) of a bulk excipient powder represent attributes that are not usually measured as part of routine raw material testing by the end user. In addition to the apparent values of these surface characteristics, their intra- and inter-lot heterogeneity can influence functionality, and in some instances, significantly cause it to change.https://jefc.scholasticahq.com/article/1128-characterization-of-solid-excipients-delving-deeper-by-probing-the-surface
spellingShingle Shireesh Apte
Characterization of solid excipients: delving deeper by probing the surface
Journal of Excipients and Food Chemicals
title Characterization of solid excipients: delving deeper by probing the surface
title_full Characterization of solid excipients: delving deeper by probing the surface
title_fullStr Characterization of solid excipients: delving deeper by probing the surface
title_full_unstemmed Characterization of solid excipients: delving deeper by probing the surface
title_short Characterization of solid excipients: delving deeper by probing the surface
title_sort characterization of solid excipients delving deeper by probing the surface
url https://jefc.scholasticahq.com/article/1128-characterization-of-solid-excipients-delving-deeper-by-probing-the-surface
work_keys_str_mv AT shireeshapte characterizationofsolidexcipientsdelvingdeeperbyprobingthesurface