Drop-On-Demand Dispensing of Pharmaceutical Suspensions: Correlation of Material Attributes and Operating Conditions to Process Performance

Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
2010 AIChE Annual Meeting
AIChE Annual Meeting
November 10, 2010 - 7:00pm
The ability to produce drops on demand is critical to microdosing applications, such as dispensing inks, polymers, and other biological fluids. In the pharmaceutical industry microdosing can be used to reliably fill capsules with multiple materials at strictly controlled ratios, under full closed loop control. Additionally the emergent trend of personalized dosing for therapies in hospitals could lead to personalized microbatch manufacturing based on drop on demand microdosing. While the satisfactory operation of microdosing equipment options for different liquids is usually confined to a narrow region of the system parameter space, there is still a significant lack of understanding of the underlying correlations between material attributes, processing parameters and properties of the dispensed droplets. In this work, a piezo-electric valve, specifically a 50 micron MJ-AT-01 valve from Microfab, has been chosen as a typical micro-dispensing device. The process design space has been mapped for materials with varied properties (viscosity, surface tension, etc.). Process parameters considered include dwell voltage and rising time among others. To better investigate the underlying physical phenomena governing the performance of the system, numerical simulations were performed of the flow of both Newtonian and non-Newtonian fluids through the dispensing nozzle. Specific focus was placed on the resolution of the flow directly before and after the nozzle orifice. The results of this study could provide a substantial contribution to the ability to a priori assess the operating parameters required to reliably dispense drops on demand for different materials.
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