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In Vitro Regional Deposition of Nasal Sprays in an Idealized Nasal Inlet: Comparison with In Vivo Gamma Scintigraphy

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Abstract

Purpose

To compare in vitro regional nasal deposition measurements using an idealized nasal airway geometry, the Alberta Idealized Nasal Inlet (AINI), with in vivo regional deposition for nasal drug products.

Materials and Methods

One aqueous solution formulation (NasalCrom), one aqueous suspension formulation (Nasonex) and one nasal pressurized metered dose spray device (QNASL) were selected. Two spray orientation angles, 60° and 45° from the horizontal, were selected. A steady inhalation flow rate of 7.5 L/min was selected to simulate slow inhalation through a single nostril. After actuation, the AINI was disassembled. The mass of drug deposited in each region and a downstream filter, representing penetration of drug to the lungs, was determined using ultraviolet–visible (UV–Vis) spectrophotometry.

Results

No filter (lung) deposition was detected for NasalCrom or Nasonex. Filter deposition ranged from 6 to 11% for QNASL. For NasalCrom, 45% to 69% of the dose deposited in the AINI was deposited in the vestibule and 31% to 55% was deposited in the turbinates; for Nasonex, 66% to 74% (vestibule) and 26% to 34% (turbinates); for QNASL, 90% to 100% (vestibule) and 0% to 10% (turbinates). No statistically significant difference was observed between regional deposition in vivo and in vitro for any of the formulations, except that nasopharyngeal deposition with Nasonex differed by less than 1.56% from in vivo, which while statistically significant, is unlikely to be clinically significant.

Conclusions

The AINI was able to mimic regional in vivo deposition for nasal drug products, permitting differentiation between devices based on regional deposition.

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Funding

This study was funded by the Natural Sciences and Engineering Research Council of Canada. The aluminum version of the AINI geometry was supplied by Copley Scientific.

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Authors and Affiliations

  1. Department of Mechanical Engineering, Faculty of Engineering, University of Alberta, 10-265 Donadeo Innovation Centre for Engineering, Edmonton, Canada

    John Z. Chen, Warren H. Finlay & Andrew Martin

Authors
  1. John Z. Chen
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  2. Warren H. Finlay
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  3. Andrew Martin
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Contributions

John Chen developed the methodology, conducted the experimental study, analyzed the data, and wrote the manuscript. Warren Finlay and Andrew Martin contributed to the conceptualization of the study, the development of methodology, and the analysis of data, and reviewed and edited the manuscript.

Corresponding author

Correspondence to Andrew Martin.

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Conflict of Interest

WF and AM are co-inventors of the AINI geometry, which is licensed by the University of Alberta to Copley Scientific through a royalty-bearing agreement.

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Chen, J.Z., Finlay, W.H. & Martin, A. In Vitro Regional Deposition of Nasal Sprays in an Idealized Nasal Inlet: Comparison with In Vivo Gamma Scintigraphy. Pharm Res 39, 3021–3028 (2022). https://doi.org/10.1007/s11095-022-03388-7

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  • DOI: https://doi.org/10.1007/s11095-022-03388-7

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