Simulation of roller compaction by combination of a compaction simulator and oscillating mill - A material sparing approach

Int J Pharm. 2023 Sep 25:644:123281. doi: 10.1016/j.ijpharm.2023.123281. Epub 2023 Jul 29.

Abstract

This study investigates the feasibility of a compaction simulator and oscillating mill to mimic a roller compactor as a material sparing approach for process development. Microcrystalline cellulose and dicalcium phosphate dihydrate were selected to represent soft and hard materials, respectively. The relative density of ribbons and riblets was determined using a pycnometer and granules size distribution was determined by laser diffraction. Tablet tensile strength and relative density were determined using a hardness tester and pycnometer, respectively. This study showed that the relative density of riblets and ribbons were similar between 1 and 12 kN/cm, which indicates that the compaction simulator adequately mimics the compaction of the roller compactor using a Kp of 1. The size distribution of granules produced by the oscillating mill and roller compactor were similar, which indicates that the oscillating mill adequately mimics the roller compactor when using a similar gap and sieve design. Finally, the tablet tensile strength and relative density were similar independent of the applied granulation method and deformation behaviour of the material. In conclusion, the use of a compaction simulator and an oscillating mill in combination adequality mimics the roller compactor, which ultimately can save large amounts of material and time during process development.

Keywords: Compaction simulation; Roller compaction; Upscaling.

MeSH terms

  • Drug Compounding / methods
  • Particle Size
  • Tablets* / chemistry
  • Tensile Strength

Substances

  • Tablets