Scale-up of the rounding process in pelletization by extrusion-spheronization

Pharm Dev Technol. 2019 Oct;24(8):1014-1020. doi: 10.1080/10837450.2019.1621900. Epub 2019 Jun 24.

Abstract

Previously described scaling models for the spheronization process of wet extrudates are incomplete, often concluding with an adjustment of the plate speed according to the spheronizer diameter, but neglecting to give guidelines on the adjustment of the load or the process duration. In this work, existing scaling models were extended to include the load and the process time. By analyzing the final particle size and shape distributions as well as the rounding kinetics for various loads and plate speeds in spheronizers with plate diameters of 0.12 m, 0.25 m and 0.38 m, the found scaling model was validated. The peripheral speed was found to be the main influence on the rounding kinetic, while the load and the plate diameter only showed minor influence. Higher peripheral speeds, higher loads and a larger spheronizer diameter led to an increase in rounding kinetic, allowing for shorter residence times and increased throughput. However, lower peripheral speed, lower loads and lower plate diameters led to particles of increased sphericity.

Keywords: Extrusion; pellets; scale-up; spheronization; wet granulation.

MeSH terms

  • Cellulose / chemistry
  • Drug Compounding / methods
  • Excipients / chemistry
  • Kinetics
  • Lactose / chemistry
  • Microspheres
  • Particle Size
  • Pharmaceutical Preparations / chemistry*

Substances

  • Excipients
  • Pharmaceutical Preparations
  • Cellulose
  • Lactose
  • microcrystalline cellulose