NANEX: Process design and optimization

作者：Baumgartner Ramona; Matic Josip; Schrank Simone; Laske Stephan; Khinast Johannes; Roblegg Eva^*

来源：International Journal of Pharmaceutics, 2016, 506(1-2): 35-45.

DOI：10.1016/j.ijpharm.2016.04.029

• One-step nano-extrusion process
• NANEX design and optimization
• Screw configuration
• Water integration capacity
• Mean residence time
• Devolatilization

Previously, we introduced a one-step nano-extrusion (NANEX) process for transferring aqueous nano-suspensions 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 (Kollidon (R) VA64, Eudragit (R) 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.

• 出版日期2016-6-15