Laser Triangulation Based In-Line Elastic Recovery Measurement for the Determination of Ribbon Solid Fraction in Roll Compaction

J Pharm Sci. 2024 Apr;113(4):1020-1028. doi: 10.1016/j.xphs.2023.10.013. Epub 2023 Oct 13.

Abstract

Process Analytical Technology (PAT) plays a crucial role in the design of today's manufacturing lines as continuous manufacturing becomes more important. Until now PAT tools to measure the ribbon solid fraction (SFribbon) in-line are not commonly used in roll compaction. The aim of this study was therefore to establish a new approach as PAT for in-line ribbon solid fraction determination. Different placebo formulations with different binders and one formulation containing active pharmaceutical ingredient were investigated using in-line laser triangulation measurement to detect the ribbon thickness after compaction. With this the ribbon elastic recovery was determined in-line (ERin-line) while the ribbons are attached to the roll surface. It was found that the ratio (ERratio) between the total elastic recovery and ERin-line is formulation specific and not influenced by any process parameters. This enables ERratio as prediction tool for SFribbon, if the solid fraction at gap (SFgap) width is known. SFgap was determined with ribbon mass flow measurement or based on the Midoux model, a simplified Johanson model, gaining two prediction models for SFribbon. Both models showed good agreement of the predicted SFribbon and the measured one.

Keywords: Elastic recovery; In-line; Laser triangulation; Process analytical technology (PAT); Ribbon solid fraction; Roll compaction.

MeSH terms

  • Drug Compounding
  • Lasers*
  • Particle Size
  • Powders
  • Tablets
  • Technology, Pharmaceutical*

Substances

  • Tablets
  • Powders