Assessment of the Influence Factors on Nasal Spray Droplet Velocity Using Phase-Doppler Anemometry (PDA) |
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Authors: | Xiaofei Liu William H Doub Changning Guo |
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Institution: | (1) U. S. Food and Drug Administration, Division of Pharmaceutical Analysis, 1114 Market Street, Room 1002, St. Louis, Missouri 63101, USA; |
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Abstract: | Droplet velocity is an important parameter that can be used to characterize nasal spray products. In this study, a phase-Doppler
anemometry (PDA) system was used to measure the droplet velocities of nasal sprays. A survey of seven commercial nasal spray
products showed a range of droplet velocities from 6.7 to 19.2 m/s, all significantly different from each other. A three-level,
four-factor Box–Behnken design of experiments (DOE) methodology were applied to investigate the influences of actuation parameters
and formulation properties on nasal spray droplet velocity using a set of placebo formulations. The DOE study shows that all
four input factors (stroke length, actuation velocity, concentration of the gelling agent, and concentration of the surfactant)
have significant influence on droplet velocity. An optimized quadratic model generated from the DOE results describes the
inherent relationships between the input factors and droplet velocity thus providing a better understanding of the input factor
influences. Overall, PDA provides a new in vitro characterization method for the evaluation of inhalation drugs through assessment of spray velocity and may assist in product
development to meet drug delivery equivalency requirements. |
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Keywords: | |
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