Impact of blend properties and process variables on the blending performance
In this study, quantitative relationships were established between blend properties, process settings and blending responses via multivariate data-analysis. Four divergent binary blends were composed in three different ratios and processed at various throughputs and impeller speeds. Additionally, different impeller configurations were tested to see their impact on the overall blending performance. During each run, feeder mass flows were compared with the API concentration (BU) in order to investigate the dampening potential of the blender. The blender hold-up mass (HM), mean residence time (MRT), strain on the powder (#BP) and BU variability (RSDBU) were determined as blending descriptors and analyzed via PLS-regression. This elucidated the correlation between process settings (i.e. throughput and impeller speed) and blending responses, as well as the impact of blend properties on MRT and RSDBU. Furthermore, the study revealed that HM does not need to be in steady state conditions to assure a stable BU, while it became clear that long/large feeder deviations can only be dampened by the blender when using dedicated impeller configurations. Overall, this study demonstrated the generic application of the blender, while the developed PLS models could be used to predict the blender performance based on the blend properties.
Materials used (among others):
MCL100 Microcelac® 100/Co-processed microcrystalline cellulose and lactose, Caffeine anhydrous powder, PH101 Avicel PH-101/Microcrystalline cellulose, T 80 Tablettose 80/Lactose
B. Bekaert, W. Grymonpré, A. Novikova, C. Vervaet, V. Vanhoorne,
Impact of blend properties and process variables on the blending performance,
International Journal of Pharmaceutics, 2021, 121421, ISSN 0378-5173,
https://doi.org/10.1016/j.ijpharm.2021.121421.