Using Quality by Design Approach to Correlate Patient Usage to the In Vitro Performance of a Nasal Spray Product

This study shows how high-resolution measurements of human usage (“ergonometrics”) of a commercially available nasal spray pump device vary between different age groups of people, including the effect of dominant vs. non-dominant hand, and how these ergonometrics are related to in vitro performance. The QbD approach used in the study was designed to fit with FDA guidance that calls for nasal spray pump developers to replicate actual patient actuation parameters.