Abstract
A mathematical approach was developed to estimate spray deposition patterns in the nasal cavity based on the geometric relationships between the emitted spray plume and the anatomical dimensions of the nasal valve region of the nasal cavity. Spray plumes were assumed to be spherical cones and the nasal valve region was approximated as an ellipse. The effect of spray plume angle (15–85°) on the fraction of the spray able to pass through the nasal valve (deposition fraction) was tested for a variety of nasal valve (ellipse) shapes and cross-sectional areas based on measured dimensions from pediatric and adult nasal cavities. The effect of the distances between the tip of the nasal spray device and the nasal valve (0.2–1.9 cm) on the deposition fraction was also tested. Simulation results show that (1) decreasing spray plume angles resulted in higher deposition fractions, (2) deposition fraction was inversely proportional to the spray distance and the nasal valve (ellipse) major/minor axis ratio, and (3) for fixed major/minor axis ratios, improved deposition occurred with larger nasal valve cross-sectional areas. For a typical adult nasal valve, plume angles of less than 40° emitted from a distance of 1 cm resulted depositions greater than 90% within the main nasal cavity, whereas for a 12-year-old child, only the most narrow plume angles (< 20°) administered resulted in significant deposition beyond the nasal valve.
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Funding
This study was funded by an FDA Grant to the National Institute for Pharmaceutical Technology and Education (NIPTE) titled “The Critical Path Manufacturing Sector Research Initiative (U01)”: grant no. 5U01FD004275.
The results and conclusions presented reflect the opinions of the authors and not those of the funding agencies.
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Guest Editors: Ajaz S. Hussain, Kenneth Morris, and Vadim J. Gurvich
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Foo, M.Y., Sawant, N., Overholtzer, E. et al. A Simplified Geometric Model to Predict Nasal Spray Deposition in Children and Adults. AAPS PharmSciTech 19, 2767–2777 (2018). https://doi.org/10.1208/s12249-018-1031-2
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DOI: https://doi.org/10.1208/s12249-018-1031-2