TY - JOUR
T1 - How Does the Dissimilarity of Screw Geometry Impact Twin-screw Melt Granulation?
AU - Kittikunakorn, Nada
AU - Paul, Shubhajit
AU - Koleng, John J.
AU - Liu, Tongzhou
AU - Cook, Rachel
AU - Yang, Fengyuan
AU - Bi, Vivian
AU - Durig, Thomas
AU - Sun, Changquan Calvin
AU - Kumar, Aditya
AU - Zhang, Feng
N1 - Publisher Copyright:
© 2020
PY - 2021/2/1
Y1 - 2021/2/1
N2 - Using a model formulation of 80% gabapentin and 20% hydroxypropyl cellulose (KlucelTM), we investigate how differences in the geometry of mixing elements in the Leistritz Nano-16 and Micro-18 extruders affect granulation mechanisms and the properties of the resulting granules. Two extruders, Leistritz Nano-16 and Micro-18, commonly used in development and manufacturing, respectively, were used. The kneading blocks of the Nano-16 extruder are less efficient in dispersive mixing than the kneading blocks of the Micro-18 due to the thinner discs (2.5 mm wide) of the Nano-16. Therefore, our model formulation could be granulated only under a higher degree of fill (DF) by enhancing the axial compaction and heating of the barrel. In contrast, the thicker (5 mm wide) kneading blocks of the Micro-18 extruder provide efficient dispersive mixing that enables granulation without axial compaction and barrel heating. The higher specific mechanical energy (SME) achieved at higher screw speeds and lower feed rates led to more granulation. Because of the difference in granulation mechanisms between the two extruders, critical processing parameters also differed. Tabletability and degradant content of granules correlated positively with DF for the Nano-16 but with SME for the Micro-18 extruder.
AB - Using a model formulation of 80% gabapentin and 20% hydroxypropyl cellulose (KlucelTM), we investigate how differences in the geometry of mixing elements in the Leistritz Nano-16 and Micro-18 extruders affect granulation mechanisms and the properties of the resulting granules. Two extruders, Leistritz Nano-16 and Micro-18, commonly used in development and manufacturing, respectively, were used. The kneading blocks of the Nano-16 extruder are less efficient in dispersive mixing than the kneading blocks of the Micro-18 due to the thinner discs (2.5 mm wide) of the Nano-16. Therefore, our model formulation could be granulated only under a higher degree of fill (DF) by enhancing the axial compaction and heating of the barrel. In contrast, the thicker (5 mm wide) kneading blocks of the Micro-18 extruder provide efficient dispersive mixing that enables granulation without axial compaction and barrel heating. The higher specific mechanical energy (SME) achieved at higher screw speeds and lower feed rates led to more granulation. Because of the difference in granulation mechanisms between the two extruders, critical processing parameters also differed. Tabletability and degradant content of granules correlated positively with DF for the Nano-16 but with SME for the Micro-18 extruder.
UR - http://www.scopus.com/inward/record.url?scp=85096857952&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85096857952&partnerID=8YFLogxK
U2 - 10.1016/j.ejps.2020.105645
DO - 10.1016/j.ejps.2020.105645
M3 - Article
C2 - 33207275
AN - SCOPUS:85096857952
SN - 0928-0987
VL - 157
JO - European Journal of Pharmaceutical Sciences
JF - European Journal of Pharmaceutical Sciences
M1 - 105645
ER -