Dissolution and disintegration kinetics of high-active pharmaceutical granules produced at laboratory and manufacturing scale
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F60461373%3A22340%2F16%3A43901970" target="_blank" >RIV/60461373:22340/16:43901970 - isvavai.cz</a>
Result on the web
<a href="http://dx.doi.org/10.1016/j.ejpb.2016.04.005" target="_blank" >http://dx.doi.org/10.1016/j.ejpb.2016.04.005</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.ejpb.2016.04.005" target="_blank" >10.1016/j.ejpb.2016.04.005</a>
Alternative languages
Result language
angličtina
Original language name
Dissolution and disintegration kinetics of high-active pharmaceutical granules produced at laboratory and manufacturing scale
Original language description
The effect of process scale-up from 4 to 400-L high-shear granulator on the release kinetics of the active ingredient from pharmaceutical granules has been investigated. The dissolution and disintegration rates of the granules were measured simultaneously by the combination of UV/vis spectroscopy and static light scattering. The granule batches were found to consist of sub-populations with qualitatively different dissolution behavior: ?weaker? granules that disintegrated during dissolution, and ?stronger? granules that retained their size and from which the active ingredient was gradually leached. The existence of these sub-populations was attributed to non-uniform distribution of normal and shear forces that prevail in granulators of different size. This hypothesis was confirmed by preparing granules at increasing values of the Froude number at the 4-L scale, and observing a transition from the break-up dissolution mode to the leaching dissolution mode with increasing granule densification. The simultaneous observation of solute concentration and particle size distribution during granules dissolution proved to be a useful tool for the understanding of dissolution mechanisms and for identifying non-uniformities of process conditions that can occur during scale-up. ? 2016 Elsevier B.V.
Czech name
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Czech description
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Classification
Type
J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)
CEP classification
CI - Industrial chemistry and chemical engineering
OECD FORD branch
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Result continuities
Project
Result was created during the realization of more than one project. More information in the Projects tab.
Continuities
P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)<br>S - Specificky vyzkum na vysokych skolach
Others
Publication year
2016
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
European Journal of Pharmaceutics and Biopharmaceutics
ISSN
0939-6411
e-ISSN
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Volume of the periodical
106
Issue of the periodical within the volume
September 2016
Country of publishing house
US - UNITED STATES
Number of pages
10
Pages from-to
107-116
UT code for WoS article
000382338100014
EID of the result in the Scopus database
2-s2.0-84963705407