title: Assessment of the influence factors on nasal spray droplet velocity using phase-Doppler anemometry (PDA).
abstract: Droplet velocity is an important parameter that can be used to characterize nasal spray products. In this study, a phase-Doppler anemometry (PDA) system was used to measure the droplet velocities of nasal sprays. A survey of seven commercial nasal spray products showed a range of droplet velocities from 6.7 to 19.2 m/s, all significantly different from each other. A three-level, four-factor Box-Behnken design of experiments (DOE) methodology were applied to investigate the influences of actuation parameters and formulation properties on nasal spray droplet velocity using a set of placebo formulations. The DOE study shows that all four input factors (stroke length, actuation velocity, concentration of the gelling agent, and concentration of the surfactant) have significant influence on droplet velocity. An optimized quadratic model generated from the DOE results describes the inherent relationships between the input factors and droplet velocity thus providing a better understanding of the input factor influences. Overall, PDA provides a new in vitro characterization method for the evaluation of inhalation drugs through assessment of spray velocity and may assist in product development to meet drug delivery equivalency requirements.
authors.affiliation: U. S. Food and Drug Administration, Division of Pharmaceutical Analysis, 1114 Market Street, Room 1002, St. Louis, Missouri 63101, USA.
authors.forename: Xiaofei
authors.initials: X
authors.lastname: Liu
authors.forename: William H
authors.initials: WH
authors.lastname: Doub
authors.forename: Changning
authors.initials: C
authors.lastname: Guo
mesh_terms: D000281:Administration, Intranasal; D000336:Aerosols; D002482:Cellulose / Q000032:analysis; D016503:Drug Delivery Systems; D005079:Excipients; D005782:Gels; D006801:Humans; D059085:Nasal Sprays; D009330:Nebulizers and Vaporizers; D010316:Particle Size; D011136:Polysorbates; D012107:Research Design; D013501:Surface-Active Agents / Q000378:metabolism; D013678:Technology, Pharmaceutical / Q000295:instrumentation / Q000379:methods; D014783:Viscosity
chemical_list: D000336:Aerosols; D005079:Excipients; D005782:Gels; D059085:Nasal Sprays; D011136:Polysorbates; D013501:Surface-Active Agents; D002482:Cellulose