In Vitro Assessment of Spray Deposition Patterns in a Pediatric (12 Year-Old) Nasal Cavity Model
Nasal sprays available for the treatment of cold and allergy symptoms currently use identical formulations and devices for adults as well as for children. Due to the obvious differences between the nasal airway dimensions of a child and those of an adult, the performance of nasal sprays in children was evaluated.
Deposition patterns of nasal sprays administered to children were tested using a nasal cast based on MRI images obtained from a 12 year old child’s nasal cavity. Test formulations emitting a range of spray patterns were investigated by actuating the device into the pediatric nasal cast under controlled conditions.
The results showed that the nasal sprays impacted in the anterior region of the 12 year old child’s nasal cavity, and only limited spray entered the turbinate region – the effect site for most topical drugs and the primary absorptive region for systemically absorbed drugs.
Differences in deposition patterns following the administration of nasal sprays to adults and children may lead to differences in efficacy between these populations. Greater anterior deposition in children may result in decreased effectiveness, greater anterior dosage form loss, and the increased potential for patient non-compliance.
Key Wordsanterior deposition nasal cast nasal spray pediatrics plume angle
ACKNOWLEDGMENTS AND DISCLOSURES
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# 5U01FD004275.
The results and conclusions presented reflect the opinions of the authors and not those of the funding agencies.
- 11.Swift DL, Proctor DF. Access of air to the respiratory tract. Respir Def Mech. 1977;5(part 1):63–93.Google Scholar
- 13.Andersen I, Proctor D. Measurement of nasal mucociliary clearance. Eur J Respir Dis Suppl. 1982;127:37–40.Google Scholar
- 17.USFDA. Guidance for Industry “Bioavailability and bioequivalence studies for nasal aerosols and nasal sprays for local action”. Center for Drug Evaluation and Research (CDER), Rockville, MD. 2003.Google Scholar
- 33.Warnken ZN, Smyth HDC, Davis DA, Weitman S, Kuhn JG, Williams RO. Personalized medicine in nasal delivery: the use of patient-specific administration parameters to improve nasal drug targeting using 3D-printed nasal replica casts. Mol Pharm. 2018. https://doi.org/10.1021/acs.molpharmaceut.7b00702.
- 34.Foo MY. Deposition pattern of nasal sprays in the human nasal airway: interactions among formulation, device, anatomy and administration techniques. Ph.D. Dissertation, University of Iowa, Iowa City, IA: ProQuest; 2007.Google Scholar
- 38.Chabacano. Olfactory System [Internet]. Wikimedia Commons. Copyright information: Creative Commons Attribution-ShareAlike (CC BY-SA 2.5) [cited 2017 Oct 14]. Available from: https://upload.wikimedia.org/wikipedia/commons/2/20/Olfactory_system.svg