Elucidation of mass transfer mechanisms in pellet formation by spheronization

Eur J Pharm Biopharm. 2021 Mar:160:92-99. doi: 10.1016/j.ejpb.2021.01.013. Epub 2021 Jan 29.

Abstract

Previously published mechanisms of pellet formation during extrusion-spheronization include a transfer of material between different granules. This research aimed to specify the origin of this transfered mass, enabling further insight into the extrusion-spheronization process. Granules of various diameters were rounded simultaniously in a spheronizer to ascertain if mass transfer between smaller and larger granules is truly in balance, or if mass transfer from smaller to larger granules is preferred. Granules were also marked with a fluorescent tracer to enable quantification of mass transfer. By using differently sized and shaped granules as starting material, different modes of mass transfer were investigated. Samples were taken after various process durations to investigate the kinetics of the tranfer mechanism. It was found that both small and large granules dispense and receive mass during spheronization. In general, small granules increase their size, while large granules maintain their size or show a slight size decrease, resulting in the particularly narrow monomodal size distribution.

Keywords: Extrusion; Granulation; Mass transfer; Pellets; Spheronization; Wet granulation.

MeSH terms

  • Chemistry, Pharmaceutical
  • Drug Compounding / methods*
  • Excipients / chemistry*
  • Particle Size

Substances

  • Excipients