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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International Pharmaceutical Excipients Council
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doaj-7c24ecabc32143e2b1338f9a23f89cc12020-11-24T21:47:09ZengInternational Pharmaceutical Excipients CouncilJournal of Excipients and Food Chemicals2150-2668Characterization 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.http://jefc.scholasticahq.com/article/1128-characterization-of-solid-excipients-delving-deeper-by-probing-the-surface.pdf |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Shireesh Apte |
spellingShingle |
Shireesh Apte Characterization of solid excipients: delving deeper by probing the surface Journal of Excipients and Food Chemicals |
author_facet |
Shireesh Apte |
author_sort |
Shireesh Apte |
title |
Characterization of solid excipients: delving deeper by probing the surface |
title_short |
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_sort |
characterization of solid excipients: delving deeper by probing the surface |
publisher |
International Pharmaceutical Excipients Council |
series |
Journal of Excipients and Food Chemicals |
issn |
2150-2668 |
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. |
url |
http://jefc.scholasticahq.com/article/1128-characterization-of-solid-excipients-delving-deeper-by-probing-the-surface.pdf |
work_keys_str_mv |
AT shireeshapte characterizationofsolidexcipientsdelvingdeeperbyprobingthesurface |
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1725899023343157248 |