Elucidation of the powder flow pattern in a twin-screw LIW-feeder for various refill regimes

Int J Pharm. 2023 Jan 25:631:122534. doi: 10.1016/j.ijpharm.2022.122534. Epub 2022 Dec 20.

Abstract

The importance of residence time distribution modeling is acknowledged as a tool for enabling material tracking and control within a continuous manufacturing line in order to safeguard both product quality and production efficiency. One of the first unit-operations into a continuous direct compression line (i.e. CDC-line) worthwhile doing extensive RTD-analysis upon are the LIW-feeders since they dose the ingredients in a controlled way following the label claim and hence can directly influence critical quality attributes like content uniformity. An NIR measurement method was developed determining the RTD of selected powders at specific feeder settings. Step-change experiments using sodium saccharin as a tracer were conducted. In order to gain and in depth understanding of the material flow, spatial samples throughout the hopper were taken at predefined timepoints during the step change experiments. This revealed the presence of a bypass trajectory along the edges of the agitator, while in the center of the agitator an inner mixing volume in which the tracer concentration lags behind seemed to be present. Finally, a model based on a plug flow and continuous stirred tank reactor was evaluated. The fitted model was not able to capture this complex flow behavior and shows the need for an extended compartmental model distinguishing between a bypass trajectory formed by the agitator and an inner mixing volume.

Keywords: Continuous manufacturing; NIR spectroscopy; Residence time distribution; Twin-screw LIW-feeder.

MeSH terms

  • Chemistry, Pharmaceutical* / methods
  • Pharmaceutical Vehicles
  • Powders
  • Pressure
  • Technology, Pharmaceutical* / methods

Substances

  • Powders
  • Pharmaceutical Vehicles