Systematic Study of the Effects of High Shear Granulation Parameters on Process Yield, Granule Size, and Shape by Dynamic Image Analysis

• Published in: Pharmaceutics Vol. 13; no. 11; p. 1894
• Main Authors: Macho, Oliver, Gabrišová, Ľudmila, Peciar, Peter, Juriga, Martin, Kubinec, Róbert, Rajniak, Pavol, Svačinová, Petra, Vařilová, Tereza, Šklubalová, Zdenka
• Format: Journal Article
• Language: English
• Published: Basel MDPI AG 08-11-2021; MDPI
• Subjects: Aqueous solutions; Cellulose; dynamic image analysis; granules; high shear granulation; Humidity; liquid to solid ratio; Morphology; Particle size; Pharmaceutical industry; United Kingdom > UK; Czech Republic
• ISSN: 1999-4923; 1999-4923
• DOI: 10.3390/pharmaceutics13111894

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.