Anatomically realistic nasal replicas capturing the range of nasal spray drug delivery in adults

Ali Alfaifi; Sana Hosseini; Amir R Esmaeili; Ross Walenga; Andrew Babiskin; Theodore Schuman; Worth Longest; Michael Hindle; Laleh Golshahi

doi:10.1016/j.ijpharm.2022.121858

Anatomically realistic nasal replicas capturing the range of nasal spray drug delivery in adults

Int J Pharm. 2022 Jun 25:622:121858. doi: 10.1016/j.ijpharm.2022.121858. Epub 2022 May 26.

Authors

Ali Alfaifi¹, Sana Hosseini¹, Amir R Esmaeili¹, Ross Walenga², Andrew Babiskin², Theodore Schuman³, Worth Longest⁴, Michael Hindle⁵, Laleh Golshahi⁶

Affiliations

¹ Department of Mechanical and Nuclear Engineering, Virginia Commonwealth University, Richmond, VA, USA.
² Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
³ Department of Otolaryngology - Head and Neck Surgery, VCU Health, Richmond, VA, USA.
⁴ Department of Mechanical and Nuclear Engineering, Virginia Commonwealth University, Richmond, VA, USA; Department of Pharmaceutics, Virginia Commonwealth University, Richmond, VA, USA.
⁵ Department of Pharmaceutics, Virginia Commonwealth University, Richmond, VA, USA.
⁶ Department of Mechanical and Nuclear Engineering, Virginia Commonwealth University, Richmond, VA, USA. Electronic address: lgolshahi@vcu.edu.

PMID: 35643344
DOI: 10.1016/j.ijpharm.2022.121858

Abstract

To improve the relationships between commonly conducted in vitro studies for locally-acting nasal spray drug products with in vivo regional deposition, this study developed a set of in vitro adult nasal geometries that captured the range of nasal drug delivery to the region posterior to internal nasal valve (INV), also known as posterior delivery (PD), and evaluated their performance with existing in vivo data. The PD of fluticasone propionate (FP) and fluticasone furoate (FF) in 40 nasal cavities was statistically analyzed to identify three airway models representing the low, mean, and high PD in adults. The models were also externally validated by comparing the in vitro nasal deposition from a different drug product (mometasone furoate (MF)) with the relevant in vivo data. The three selected geometries represented the low, mean, and high PD with multiple nasal sprays. They were verified in terms of reproducibility of in vitro data and validated by showing a reasonable agreement with preexisting in vivo MF PD despite differences in administration and defining the regions. The three models are envisioned to potentially facilitate the development of locally-acting nasal sprays and provide a better understanding of how in vitro metrics relate to in vivo regional nasal deposition.

Keywords: Anatomical variability; Bioequivalence; In vitro aerosol testing; Locally-acting drugs; Nasal spray; Regional deposition.

MeSH terms

Administration, Intranasal
Fluticasone
Mometasone Furoate
Nasal Sprays*
Nose*
Reproducibility of Results

Substances

Nasal Sprays
Mometasone Furoate
Fluticasone