Effect of process scale-up on the dissolution of granules with a high content of active pharmaceutical ingredient

Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F60461373%3A22340%2F15%3A43899914" target="_blank" >RIV/60461373:22340/15:43899914 - isvavai.cz</a>
Result on the web
<a href="http://apps.webofknowledge.com/full_record.do?product=WOS&search_mode=GeneralSearch&qid=4&SID=S2K2CD6AfClgauzA9GP&page=1&doc=1" target="_blank" >http://apps.webofknowledge.com/full_record.do?product=WOS&search_mode=GeneralSearch&qid=4&SID=S2K2CD6AfClgauzA9GP&page=1&doc=1</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.powtec.2015.04.028" target="_blank" >10.1016/j.powtec.2015.04.028</a>

Result language
angličtina
Original language name
Effect of process scale-up on the dissolution of granules with a high content of active pharmaceutical ingredient
Original language description
The robustness and parametric sensitivity of a high-shear wet granulation process during scale-up were investigated for a formulation containing over 50% by weight of a hydrophobic active pharmaceutical ingredient (API). The sensitivity of granule properties-such as particle site distribution, bulk density and dissolution rate with respect to both formulation (binder/solids ratio) and process parameters (agitation rate and wet massing time) was determined at three different scales (0.5, 4.0 and 25.0 L).For a fixed impeller speed at a given granulator scale, the dissolution rate was found to be strongly correlated with bulk density, and both parameters could be controlled relatively precisely by the wet massing time. However, during scale-up and for variable agitation rates (expressed by the dimensionless Froude number) dissolution rate was found to be a non-trivial function of both granule size distribution and granule density. A set of process parameters for which the formulation was
Czech name
—
Czech description
—

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
—

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

Similar results(10)