Katrina Zalokoski1, Neil Anderson1, Gareth Hardwell1 & Cristina Rey-Blanes1
1Chiesi, Unit 1-3 Bath Road Industrial Estate, Bath Road, Chippenham, SN14 0AB, United Kingdom
Summary
Resonant Acoustic Mixing (RAM) is an alternative mixing technology that can be used to produce dry powder blends. The mixing happens by oscillation of the mixing vessel in a vertical direction, while at the resonant frequency of the system. Due to this, the technology can generate largely homogeneous and aerosolizable blends in a short time. Two different Design of Experiments (DoE) have been performed, aiming to obtain comparison between blends manufactured by RAM and High Shear (HS) mixing. In addition, the lab-scale scalability of four blends was studied. A New Chemical Entity (NCE) was employed as a model Active Pharmaceutical Ingredient (API) and two different carriers were used for the study.
The results obtained showed how the blends manufactured by RAM obtained a comparable homogeneity and aerodynamic performance to those manufactured by HS mixing. In addition, four different RAM manufactured blends were scaled up to three different batch sizes, with no parameter adjustments, in order to investigate the scalability of the RAM manufactured blends. Three out of four of the blends showed comparable results with for the different batch sizes, with the fourth batch showed an increased deposition in the pre-separator, with increasing batch size, probably due to a combination of high vessel fill volume (%) and high acceleration levels (90 g).
Future research will focus on further investigation on producing blends with different carrier/API combinations, trialling the scalability of the process at larger scale or the use of the technology for other applications, like mechanofusion or API encapsulation.