Nano-extrusion: a one-step process for manufacturing of solid nanoparticle formulations directly from the liquid phase

AAPS PharmSciTech. 2013 Jun;14(2):601-4. doi: 10.1208/s12249-013-9946-0. Epub 2013 Mar 6.

Abstract

This paper presents a novel one-step process for converting a liquid stabilized nano-suspension into a solid formulation via hot-melt extrusion combined with an internal devolatilization process (nano-extrusion, NANEX). A polymer (Soluplus®) was fed into the extruder and molten, after which a stable nano-suspension was added via side-feeding devices. The solvent (water) was removed by devolatilization and the polymer solidified at the outlet. The solid material can be tableted or filled in a capsule directly. The results showed that the obtained extrudates comprised nanocrystals in the de-aggregated form, confirming that a solid nano-formulation was prepared. This method is capable of overcoming many of the problems associated with other processes involving solid nano-dosage forms and poses a straightforward approach towards manufacturing such products.

MeSH terms

  • Chemistry, Pharmaceutical
  • Dosage Forms
  • Hot Temperature
  • Microscopy, Electron, Scanning
  • Nanoparticles*
  • Nanotechnology*
  • Particle Size
  • Polyethylene Glycols / chemistry
  • Polyvinyls / chemistry
  • Solvents / chemistry
  • Spectrometry, X-Ray Emission
  • Technology, Pharmaceutical / methods*
  • Titanium / chemistry
  • Water / chemistry

Substances

  • Dosage Forms
  • Polyvinyls
  • Solvents
  • polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer
  • Water
  • titanium dioxide
  • Polyethylene Glycols
  • Titanium