Systematic Study of the Effects of High Shear Granulation Parameters on Process Yield, Granule Size, and Shape by Dynamic Image Analysis
Oliver Macho,
Ľudmila Gabrišová,
Peter Peciar,
Martin Juriga,
Róbert Kubinec,
Pavol Rajniak,
Petra Svačinová,
Tereza Vařilová,
Zdenka Šklubalová
Affiliations
Oliver Macho
Institute of Process Engineering, Faculty of Mechanical Engineering, Slovak University of Technology in Bratislava, Námestie Slobody 17, 812 31 Bratislava, Slovakia
Ľudmila Gabrišová
Institute of Process Engineering, Faculty of Mechanical Engineering, Slovak University of Technology in Bratislava, Námestie Slobody 17, 812 31 Bratislava, Slovakia
Peter Peciar
Institute of Process Engineering, Faculty of Mechanical Engineering, Slovak University of Technology in Bratislava, Námestie Slobody 17, 812 31 Bratislava, Slovakia
Martin Juriga
Institute of Process Engineering, Faculty of Mechanical Engineering, Slovak University of Technology in Bratislava, Námestie Slobody 17, 812 31 Bratislava, Slovakia
Róbert Kubinec
Department of Analytical Chemistry, Faculty of Natural Sciences, Comenius University in Bratislava, Ilkovičova 6, 842 15 Bratislava 4, Slovakia
Pavol Rajniak
Department of Chemical and Biochemical Engineering, Faculty of Chemical and Food Technology, Slovak University of Technology in Bratislava, Radlinského 9, 812 37 Bratislava, Slovakia
Petra Svačinová
Department of Pharmaceutical Technology, Faculty of Pharmacy in Hradec Králové, Charles University, Ak. Heyrovského 1203, 500 05 Hradec Králové, Czech Republic
Tereza Vařilová
Department of Pharmaceutical Technology, Faculty of Pharmacy in Hradec Králové, Charles University, Ak. Heyrovského 1203, 500 05 Hradec Králové, Czech Republic
Zdenka Šklubalová
Department of Pharmaceutical Technology, Faculty of Pharmacy in Hradec Králové, Charles University, Ak. Heyrovského 1203, 500 05 Hradec Králové, Czech Republic
The aim of the work was to analyze the influence of process parameters of high shear granulation on the process yield and on the morphology of granules on the basis of dynamic image analysis. The amount of added granulation liquid had a significant effect on all monitored granulometric parameters and caused significant changes in the yield of the process. In regard of the shape, the most spherical granules with the smoothest surface were formed at a liquid to solid ratio of ≈1. The smallest granules were formed at an impeller speed of 700 rpm, but the granules formed at 500 rpm showed both the most desirable shape and the highest process yield. Variation in the shape factors relied not only on the process parameters, but also on the area equivalent diameter of the individual granules in the batch. A linear relationship was found between the amount of granulation liquid and the compressibility of the granules. Using response surface methodology, models for predicting the size of granules and process yield related to the amount of added liquid and the impeller speed were generated, on the basis of which the size of granules and yield can be determined with great accuracy.
