Comparative assessment of opioid reversal marketed and in-house nasal spray formulation by using the Malvern Spraytec

Abstract

The spray droplet size plays an important role in targeted nasal delivery. The particle size directs the
formulation to site of action based on the spray droplet size. The FDA guidance for nasal spray are getting
stringent day by day the generic players are struggling to achieve the specification as per guidance. Though
the qualitative (Q1) and quantitative (Q2) sameness optimized by generic player but the performance may
alter because of recipe used by Innovator Company. The current research focuses on the comparative
assessment of spray droplet size of marketed formulation and in-house formulation to understand the
performance similarity between them. The Malvern Spraytec instrument used to study the spray droplet size.
The method parameters were optimized and the formulations were analysed using same method parameters to
avoid the artifacts. The spray droplet size was determined and found to be similar. The employed method used
for the analysis can be used for routine analysis.