NANEX: Process design and optimization

Ramona Baumgartner, Josip Matic, Simone Schrank, Stephan Laske, Johannes Khinast, Eva Roblegg

Research output: Contribution to journalArticle

Abstract

Previously, we introduced a one-step nano-extrusion (NANEX) process for transferring aqueous nanosuspensions
into solid formulations directly in the liquid phase. Nano-suspensions were fed into molten
polymers via a side-feeding device and excess water was eliminated via devolatilization. However, the
drug content in nano-suspensions is restricted to 30 % (w/w), and obtaining sufficiently high drug
loadings in the
final formulation requires the processing of high water amounts and thus a fundamental
process understanding. To this end, we investigated four polymers with different physicochemical
characteristics (Kollidon1 VA64, Eudragit1 E PO, HPMCAS and PEG 20000) in terms of their maximum
water uptake/removal capacity. Process parameters as throughput and screw speed were adapted and
their effect on the mean residence time and
filling degree was studied. Additionally, one-dimensional
discretization modeling was performed to examine the complex interactions between the screw
geometry and the process parameters during water addition/removal. It was established that polymers
with a certain water miscibility/solubility can be manufactured via NANEX. Long residence times of the
molten polymer in the extruder and low
filling degrees in the degassing zone favored the addition/
removal of significant amounts of water. The residual moisture content in the
final extrudates was
comparable to that of extrudates manufactured without water.
Original languageEnglish
Pages (from-to)35-45
Number of pages10
JournalInternational Journal of Pharmaceutics
Volume506
Publication statusPublished - 14 Apr 2016

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  • Cite this

    Baumgartner, R., Matic, J., Schrank, S., Laske, S., Khinast, J., & Roblegg, E. (2016). NANEX: Process design and optimization. International Journal of Pharmaceutics, 506, 35-45.