Formulation and Quality – Chemical
2019 PharmSci 360
In this study, actuators on pressurized metered dose inhalers (pMDIs) were manufactured by 3D printing, combined with commercial drug canisters, and tested in vitro on the pharmaceutical quality attributes in the combination products. The diameters of the six 3D-printed inhaler nozzles were between 310 to 470 µm, slightly larger than that of the commercial inhalers (250 µm). The spray patterns showed no significant difference between 3D printed and commercial inhaler devices. For the particle size distribution (PSD) measurements, the cumulative mass depositions all matched closely. However, the fine particle fraction (FPF) show a negative linear relationship with the nozzle diameter (Correlation coefficient = 0.8481). In conclusion, the drug performance is sensitive to the pMDI actuator designs (nozzle diameter).