20.500.12556/RUL-148361 Effect of process parameters in high shear granulation on characteristics of a novel co-processed mesoporous silica material In this study, insights into the development and optimization of a co-processed excipient based on mesoporous silica are presented. The main advantage of such a material is that it is appropriate for direct tablet compression and has a sufficiently large specific surface area to be suitable for potential subsequent drug loading and formulation of (amorphous) solid dispersions. Our aim was to use a Design of Experiments approach to investigate which process parameters in high shear granulation affect the characteristics of such a co-processed material. The parameters included were the amount of binder (isomalt), the amount of water (granulation liquid), the water addition rate and the speed of the impeller. The responses evaluated and modelled were particle size and its distribution, specific surface area, bulk density, flowability, compressibility and compactibility. The models obtained showed good quality in terms of goodness of fit and predictive power. Active effects were identified for all responses, giving a thorough insight into factors affecting the material characteristics. Optimization experiments resulted in products with the desired characteristics (high specific surface area, large particle size, good flow and compression properties) and confirmed the validity of the generated models. mesoporous silica high-shear granulation design of experiment co-processing excipient mezoporozni silicijev dioksid granulacija z visokim strigom načrt poskusa soobdelava pomožne snovi farmacevtske oblike dostavni sistemi true false true Angleški jezik Slovenski jezik Članek v reviji 2023-08-18 11:24:03 2023-08-18 11:24:07 2023-08-25 10:21:24 0000-00-00 00:00:00 2023 0 0 15 str. Vol. 188, art. 106528 2023 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 615.45+615.015.14 0928-0987 10.1016/j.ejps.2023.106528 160783619 1-s2.0-S0928098723001586-main.pdf 1-s2.0-S0928098723001586-main.pdf 1 8CA1BF7FC2580E43F91AF3F82CCAD84A b9fc1ba3f19bb5d9578b1e1b9b48c00229e26aabd2633fe2f64fce4191084c92 6832d591-3da9-11ee-b9d7-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=172536 https://www.sciencedirect.com/science/article/pii/S0928098723001586 1 f5ba5ba6-3da8-11ee-b9d7-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=172535 Fakulteta za farmacijo 0 0 0