Analytical Tools for the Characterization of Nasal Spray Drug Products

The recent guidelines and regulations issued by the European Medicines Agency (EMA) and the United States Food and Drug Administration (US-FDA) regarding the invitro testing procedures for nasal spray (NS) products characterization. Nasal spray products are evaluated by using various advanced analytical techniques. This chapter summarizes the requirements of US-FDA and EMA for the measurement of osmolality, surface tension, viscosity, net fill content, justification for minimum fill, number of actuations per container, priming repriming study, droplet size distribution, spray pattern, plume geometry, and nasal spray solution shot weights. The assay, related substances and preservative content tests are also equally important tests which need to be performed and safety of nasal spray drug products; the development of analytical methods and validation of these methods are also described in the said chapter. The objective was to compile the entire nasal spray drug product specifications with their regulatory requirements from the published regulatory guidance and research articles. The literature review is carried out to identify the suitable analytical techniques, nasal spray inhaler device and formulation dependent variables. In the aforementioned chapter the critical analytical method parameters during the testing of DSD, SP and PG like stroke length (SL), actuation velocity (AV), return velocity (RV), actuation force (AF) and return force (RF) are also described. This chapter will surely give a deep insight to all the scientists engaged in development and manufacturing of quality nasal spray generic products for various regulatory markets like US and Europe.