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.
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 language | English |
|---|---|
| Pages (from-to) | 35-45 |
| Number of pages | 10 |
| Journal | International Journal of Pharmaceutics |
| Volume | 506 |
| Issue number | 1-2 |
| DOIs | |
| Publication status | Published - 14 Apr 2016 |