Using a predictive design of experiments approach to investigate the in vitro performance sensitivity of a unit dose nasal spray
Poster presented at Respiratory Drug Delivery 2016
Shaw CJ, Smith M, Newcomb A, Farina DJ, Kulkarni VS; Respiratory Drug Delivery 2016. Volume 2, 2016: 299-302.
INTRODUCTION: Unit dose nasal sprays are an attractive alternative to multi-dose devices for delivery of nasal therapies to treat conditions such as migraine pain (Imitrex® and Zomig®), cancer pain (Lazanda®), vitamin B12 deciency (Nascobal®), and heroin overdose reversal (Narcan®). Multi-dose nasal sprays have been studied using design of experiments (DoE) techniques to determine and predict their in vitro performance (e.g., shot weight, spray pattern, droplet size distribution) sensitivity to process settings (e.g., actuation velocity and stroke length) and formulation variables (e.g., viscosity, surface tension) . However, little literature has been published on the in vitro performance sensitivity of unit dose nasal spray products. This study leveraged the established multi-dose DoE methodologies to investigate the spray pattern and droplet size distribution (DSD) performance sensitivity of a popular unit dose device to controlled changes in key process settings and formulation properties.