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Leveraging In Vitro Bioequivalence Tests for Locally-Acting Suspension Nasal Sprays with Three Anatomically-Correct Replicas of Human Nasal Airways Representing Intersubject Variability

Golshahi L, Alfaifi A, Hosseini S, Esmaeili AR, Hindle M, Longest P, Schuman TA.

Respiratory Drug Delivery 2022. Volume , 2022: 37-46.

Abstract:

We previously identified the variability for in vitro nasal drug deposition in a large group of adult subjects using two different nasal spray products with significantly different nozzle designs and plume properties [1]. Based on the deposition range we identified using both devices, and the aim to minimize the number of the nasal models used to evaluate products, we selected a set of three nasal models representing low, mean, and high drug delivery to the nasal target regions across both devices. With a top-down approach, we show how by sectioning the nasal models into smaller anatomical regions, we can obtain a more detailed picture of the drug distribution in various sections of the nasal cavity for different experimental cases. Using the developed models that are intended to account for population variability, we evaluated whether in vitro bioequivalence tests currently recommended by the US Food and Drug Administration (FDA) for nasal spray suspensions reflect the differences in drug deposition found in realistic nasal models. Preliminary analysis suggests such correlations are limited.