SEDEX—Self-Emulsifying Delivery Via Hot Melt Extrusion: A Continuous Pilot-Scale Feasibility Study

Ožbej Zupančič, Aygün Doğan, Josip Matić, Varun Kushwah, Carolina Alva, Martin Spoerk, Amrit Paudel*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review


The aim of this study was to develop a continuous pilot-scale solidification and characterization of self-emulsifying drug delivery systems (SEDDSs) via hot melt extrusion (HME) using Soluplus® and Kollidon® VA-64. First, an oil-binding capacity study was performed to estimate the maximal amount of SEDDSs that the polymers could bind. Then, HME was conducted using a Coperion 18 mm ZSK18 pilot plant-scale extruder with split-feeding of polymer and SEDDS in 10, 20, and 30% w/w SEDDSs was conducted. The prepared extrudates were characterized depending on appearance, differential scanning calorimetry, wide-angle X-ray scattering, emulsification time, droplet size, polydispersity index, and cloud point. The oil-binding studies showed that the polymers were able to bind up to 50% w/w of liquid SEDDSs. The polymers were processed via HME in a temperature range between 110 and 160 °C, where a plasticizing effect of the SEDDSs was observed. The extrudates were found to be stable in the amorphous state and self-emulsified in demineralized water at 37 °C with mean droplet sizes between 50 and 300 nm. A cloud point and phase inversion were evident in the Soluplus® samples. In conclusion, processing SEDDSs with HME could be considered a promising alternative to the established solidification techniques as well as classic amorphous solid dispersions for drug delivery.

Original languageEnglish
Article number2617
Issue number12
Publication statusPublished - Dec 2022


  • hot melt extrusion (HME)
  • pilot scale production
  • SEDDSs characterization
  • self-emulsifying drug delivery systems (SEDDSs)
  • solid SEDDSs
  • ZSK18

ASJC Scopus subject areas

  • Pharmaceutical Science


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