Abstract
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 language | English |
|---|---|
| Pages (from-to) | 35-45 |
| Number of pages | 10 |
| Journal | International Journal of Pharmaceutics |
| Volume | 506 |
| Publication status | Published - 14 Apr 2016 |
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NANEX: Process design and optimization. / Baumgartner, Ramona; Matic, Josip; Schrank, Simone; Laske, Stephan; Khinast, Johannes; Roblegg, Eva.
In: International Journal of Pharmaceutics, Vol. 506, 14.04.2016, p. 35-45.Research output: Contribution to journal › Article › Research › peer-review
}
TY - JOUR
T1 - NANEX: Process design and optimization
AU - Baumgartner, Ramona
AU - Matic, Josip
AU - Schrank, Simone
AU - Laske, Stephan
AU - Khinast, Johannes
AU - Roblegg, Eva
PY - 2016/4/14
Y1 - 2016/4/14
N2 - Previously, we introduced a one-step nano-extrusion (NANEX) process for transferring aqueous nanosuspensionsinto solid formulations directly in the liquid phase. Nano-suspensions were fed into moltenpolymers via a side-feeding device and excess water was eliminated via devolatilization. However, thedrug content in nano-suspensions is restricted to 30 % (w/w), and obtaining sufficiently high drugloadings in thefinal formulation requires the processing of high water amounts and thus a fundamentalprocess understanding. To this end, we investigated four polymers with different physicochemicalcharacteristics (Kollidon1 VA64, Eudragit1 E PO, HPMCAS and PEG 20000) in terms of their maximumwater uptake/removal capacity. Process parameters as throughput and screw speed were adapted andtheir effect on the mean residence time andfilling degree was studied. Additionally, one-dimensionaldiscretization modeling was performed to examine the complex interactions between the screwgeometry and the process parameters during water addition/removal. It was established that polymerswith a certain water miscibility/solubility can be manufactured via NANEX. Long residence times of themolten polymer in the extruder and lowfilling degrees in the degassing zone favored the addition/removal of significant amounts of water. The residual moisture content in thefinal extrudates wascomparable to that of extrudates manufactured without water.
AB - Previously, we introduced a one-step nano-extrusion (NANEX) process for transferring aqueous nanosuspensionsinto solid formulations directly in the liquid phase. Nano-suspensions were fed into moltenpolymers via a side-feeding device and excess water was eliminated via devolatilization. However, thedrug content in nano-suspensions is restricted to 30 % (w/w), and obtaining sufficiently high drugloadings in thefinal formulation requires the processing of high water amounts and thus a fundamentalprocess understanding. To this end, we investigated four polymers with different physicochemicalcharacteristics (Kollidon1 VA64, Eudragit1 E PO, HPMCAS and PEG 20000) in terms of their maximumwater uptake/removal capacity. Process parameters as throughput and screw speed were adapted andtheir effect on the mean residence time andfilling degree was studied. Additionally, one-dimensionaldiscretization modeling was performed to examine the complex interactions between the screwgeometry and the process parameters during water addition/removal. It was established that polymerswith a certain water miscibility/solubility can be manufactured via NANEX. Long residence times of themolten polymer in the extruder and lowfilling degrees in the degassing zone favored the addition/removal of significant amounts of water. The residual moisture content in thefinal extrudates wascomparable to that of extrudates manufactured without water.
M3 - Article
VL - 506
SP - 35
EP - 45
JO - International Journal of Pharmaceutics
JF - International Journal of Pharmaceutics
SN - 0378-5173
ER -