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Impact of blend properties and process variables on the blending performance

By Bekaert, B; Grymonpre, W; Novikova, A; Vervaet, C; Vanhoorne, V

Published on CMKC

Abstract

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.

Journal

International Journal of Pharmaceutics. Volume 613, 2022, 121421

DOI

10.1016/j.ijpharm.2021.121421

Type of publication

Peer-reviewed journal

Affiliations

  • Ghent University
  • Fette Compacting Belgium
  • Fette Compacting GmbH

Article Classification

Research article

Classification Areas

  • Oral solid dose
  • Material characterization

Tags