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NasoNeb Nasal Nebulizer® Provides Superior Deposition Compared to Traditional Spray Pumps
Spray bottles and rinses don't compare to the delivery efficiency of the NasoNeb® Sinus Therapy System
Overall the NNSTS has demonstrated potential to deliver medication to the turbinate region of the nasal model while at the same time minimizing potential lung deposition.
Science-based Evidence | April 5, 2020
Nasal-Sprayed Particle Deposition Study Using the NasoNeb Sinus Therapy System and a Traditional Nasal Spray Pump
Spray bottles and rinses don't compare to the delivery efficiency of the NasoNeb® Sinus Therapy System
Overall the NNSTS has demonstrated potential to deliver medication to the turbinate region of the nasal model while at the same time minimizing potential lung deposition.
Introduction
Traditionally, nasal drug delivery has been used for the treatment of nasal congestion and minor complications such as allergic rhinitis. However, effectiveness is compromised by the delivery device that provides particles at high velocities leading to early deposition within the nasal vestibule rather than penetrating the nasal valve and depositing onto the main nasal passage walls in the turbinate nasal region. Therefore, studies of nasal-sprayed particles and their deposition are important for improving the efficacy of nasal drug delivery.
Commercially available nasal spray devices deposit most of the atomized drug in the anterior or front portion of the nose, missing the nasal mucosa in the turbinate or middle regions. Understanding deposition of atomized droplets within the main nasal passage provides insight into effective nasal spray targeted delivery.
Droplet Size
Droplet Size Distribution testing of the NNSTS using the Spraytec laser diffractometer
Using the laser diffractometer droplet diameters of interest were investigated at 3 and 6cm from the nozzle tip. The spray was analyzed for 500ms and the results averaged over that time period
The Perfect Droplet Size
The NasoNeb® Sinus Therapy System creates perfectly sized droplets that get past the front of your nose, and stick to those deep, hard-to-reach areas.
These solution droplets do the work for you, clearing out dust and allergens, reducing inflammation, or breaking down thick and crusty mucous making it easy to gently blow them out.
Drug Deposition
Drug deposition data of common budesonide drug preparations using the nasal model
Similar results to the chemical assay can be seen visually as the bulk of the deposition occurs in the middle segment of the model using the clear version of the model with Sargel.
NasoNeb Sinus Therapy System Delivery
Representative Images of the Transparent Model Following Budesonide Delivery via the NNSTS
Traditional Spray Pump Delivery
Representative Images of the Transparent Model Following Budesonide Delivery via a Traditional Spray Pump
References
1. Guidance for Industry. Nasal spray and inhalation solution, suspension, and spray drug products. Chemistry, manufacturing and controls documentation. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research (CDER); 2002.
2. Cheng, Y.S., H.C. Yeh, R.A. Guilmette, S.Q. Simpson, K.H. Cheng, and D.L. Swift. 1996. Nasal deposition of ultrafine particles in human volunteers and its relationship to airway geometry. Aerosol Sci. Technol. 25:274–291.
3. Guilmette, R. A., and T. J. Gagliano. "Construction of a model of human nasal airways using in vivo morphometric data." The Annals of Occupational Hygiene 38, no. VII (1994): 69-75.
4. Cheng, Y. S., T. D. Holmes, J. Gao, R. A. Guilmette, S. Li, Y. Surakitbanharn, and C. Rowlings. "Characterization of nasal spray pumps and deposition pattern in a replica of the human nasal airway." Journal of Aerosol Medicine 14, no. 2 (2001): 267-280.
5. Kulkarni V., Shaw C. Formulation and characterization of nasal sprays. An examination of nasal spray formulation parameters and excipients and their influence on key in vitro tests. Inhalation. 2012:10–15.
6. Sangolkar, S., V. Adhao, D. Mundhe, and H. Sawarkar. "Particle size determination of nasal drug delivery system: A review." Int. J. Pharm. Sci. Rev. Res 17 (2012): 66-73.
7. Xi, Jinxiang, Jiayao Eddie Yuan, Yu Zhang, Dannielle Nevorski, Zhaoxuan Wang, and Yue Zhou. "Visualization and quantification of nasal and olfactory deposition in a sectional adult nasal airway cast." Pharmaceutical research 33, no. 6 (2016): 1527-1541.
8. Xi, Jinxiang, Zhaoxuan Wang, Xiuhua April Si, and Yue Zhou. "Nasal dilation effects on olfactory deposition in unilateral and bi-directional deliveries: In vitro tests and numerical modeling." European Journal of Pharmaceutical Sciences 118 (2018): 113-123.
Meet the Expert
Mark Nagel is the Head of Aerosol Science at Trudell Medical International, has more than 25 years experience in the design, development and testing of aerosol drug delivery devices and has contributed to over 130 publications. He is the inventor on numerous patents and is a co-chair of the New Device and Emerging Therapies E-Health networking group within the International Society for Aerosols in Medicine (ISAM).
Delivery Matters
Evidence shows high viral load is found in the nasal cavity and nasopharynx for viruses and bacteria causing illness.
Methodology
Laser Diffraction Particle Sizing
The importance of controlling the particle size of nasal sprays has led the U.S. Food and Drug Administration (FDA) to recommend that laser diffraction droplet sizing be carried out for all NDAs and ANDAs for nasal drug delivery systems (1).
Nasal Model
The nasal replica was based on a MRI dataset initially reported in 1994 by Guilmette (3) and has been multiples times since then in particle deposition simulations and experiments for the Lovelace Research Institute of Albuquerque New Mexico. The MRI scans are that of a of a 53-year-old healthy male with no history of nasal abnormalities.