Using a predictive design of experiments (DoE) approach to investigate the in vitro performance sensitivity of an OTC multi-dose nasal spray

Alyssa Rubino, Maria Smith

Proveris Scientific Corporation, Hudson, Massachusetts, USA

BACKGROUND: Proveris by Design™ (PbD) is a systematic approach that formalizes product design, automates manual testing, and streamlines troubleshooting. Multi-dose nasal sprays can be studied using Design of Experiments (DoE) techniques to determine and predict their in vitro performance (e.g., shot weight, spray pattern) sensitivity to process settings (e.g., actuation velocity and stroke length). This study leverages the established DoE methodologies to investigate the pump delivery and spray pattern performance sensitivity of a popular, highly viscous, multi-dose nasal spray device to controlled changes in key process settings.

Related Works

Unit dose nasal sprays: method effects of setting stroke length on spray characteristics
Determination of the influencing factors on in vitro performance of a marketed OTC nasal spray product using a Quality by Design (QbD) and Design of Experiments (DOE) approach
Using a predictive design of experiments approach to investigate the in vitro performance sensitivity of a unit dose nasal spray
Impact of actuator design on multi-dose nasal spray characteristics