A quantitative study of the effect of process parameters on key granule characteristics in a high shear wet granulation process involving a two component pharmaceutical blend

Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F60461373%3A22340%2F15%3A43900017" target="_blank" >RIV/60461373:22340/15:43900017 - isvavai.cz</a>
Result on the web
<a href="http://apps.webofknowledge.com/full_record.do?product=UA&search_mode=GeneralSearch&qid=13&SID=U1pZHBSPBb1pKRGmC6q&page=1&doc=1" target="_blank" >http://apps.webofknowledge.com/full_record.do?product=UA&search_mode=GeneralSearch&qid=13&SID=U1pZHBSPBb1pKRGmC6q&page=1&doc=1</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.apt.2014.10.012" target="_blank" >10.1016/j.apt.2014.10.012</a>

Result language
angličtina
Original language name
A quantitative study of the effect of process parameters on key granule characteristics in a high shear wet granulation process involving a two component pharmaceutical blend
Original language description
The objective of the current work was to investigate the effect of liquid to solid ratio (L/S), impeller speed and the wet massing time on the critical quality attributes of granules in a high shear wet granulation process for a two component (API and excipient) system. The parameters were evaluated for their effect on granule properties using a design of experiment based approach. Granules were characterized for their particle size distribution, content uniformity, morphology and porosity. The liquid to solid (L/S) ratio was found to have a dominant effect on the median particle size and exhibited a clear trend. The system was found to be extremely well mixed for all conditions thus implying robust composition uniformity within and between batches, independent of process parameters. The release kinetics of granules within the batch were found to be identical, independent of particle size. The granules were found to be fairly spherical as observed through a scanning electron microscope
Czech name
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Czech description
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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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Project
<a href="/en/project/LH12115" target="_blank" >LH12115: Multi-scale analysis and design of granulation processes</a><br>
Continuities
P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)<br>S - Specificky vyzkum na vysokych skolach

Publication year
2015
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

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