Knowledge Center

Poster / Nov 12, 2017

Enhancing Amorphous Solid Dispersion Miscibility and Drug Saturation through Ternary Systems

  • Traciann Scirbona
  • Michael Puppolo
  • Iris Duarte
  • João Henriques
  • Rui Ferreira
  • David Storey
  • Dirce Macario
AAPS 2017
The original process for manufacturing amorphous solid dispersions of Drug X involved spray drying crystalline Drug X and Eudragit L100, at a 3% solids loading. Initial batches exhibited a low product yield of 46% (%w/w) and required an extensive post drying step to remove the process solvent. The yield was determined to be a consequence of low solids loading, which resulted in the production of amorphous solid dispersions with sub-micron particles that were lost to the filter and presented clogging challenges. Solubility limitations prevented the solid loading to be increased beyond 3% and therefore it was hypothesized a more advantageous approach may be hot melt extrusion, if the physical and chemical properties of Drug X were suitable for extrusion.