FDA – FRI acknowledged important tool for investigating deposition

In a recent article, the Food and Drug Administration (FDA) mentioned Fluidda’s FRI technology as an important tool to investigate regional drug deposition of the extrathoracic region, especially to measure the effects of small-airway variability. This is a valuable recognition and is very encouraging:

“However, while there are several studies which have investigated small-airway deposition using a variety of CFD Methods, very few have addressed effects of small-airway variability. A technique developed by Jan De Backer and co-workers uses four CT scans for each of several subjects to define upper airway geometries, where scans are taken after normal expiration at Functional Residual capacity (FRC) and after deep inhalation at Total Lung Capacity (TLC), before and after treatment. The scans at FRC and TLC are segmented on a lobar basis to determine airflow distribution, while the upper airways are segmented to provide geometric models for CFD analysis, where pressure outlets on the resulting upper airway models are chosen to represent airflow distribution measured via lobar segmentation.

This method, which has been termed Functional Respiratory Imaging (FRI), can then be used to predict central and peripheral deposition for all subjects in the study, where this method was used to predict central to peripheral ratios for both APIs of a combination product for several different inhalation conditions in six subjects with asthma.”

Categorised in: / February 10, 2020 4:22 pm / Published by

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