Comprehensive analysis of the spray parameters of nasal sprays containing antibiotics, anti-inflammatory and vasoconstrictive components

Abstract

Objective. To compare spraying parameters of two multicomponent nasal sprays, Polydexa with phenylephrine (Polydexa with PE) and its generic, to choose the spary with an optimal quality of spraying. Materials and methods. We used a silicone model of the nasal cavity (Koken Co. Ltd., Tokyo, Japan) to analyze spray distribution in the nasal cavity. A planar simulation model (a plate for thin-layer chromatography “silica gel 60 without fluorescence”) was used to assess spraying parameters and width. Dynamic characteristics of spraying and the dispersed composition of sprays were evaluated using shadow photography. Results. We evaluated the distribution of the spray dose in the nasal cavity using the silicone nose model. We compared dose distribution between the two sprays studied using both full and half-filled bottles. We assessed the breadth and homogeneity of the spray by analyzing the track on a planar simulation model. Shadow photography was used to evaluate the dynamic spraying characteristics, such as total duration, duration of the individual stages of spraying, spray-cone angle, as well as dispersion characteristics, including mean particle sizes and particle size distributions. Conclusion. Experiments with the silicone nose model demonstrated that Polydexa with PE creates a larger area of spray distribution than generic, which indicates its better coverage of the nasal mucosa. Сomparison of the dynamic spraying characteristics showed a significant difference between the two sprays studied caused by differences in the design of their vials. The dispersed compositions of both sprays were similar, although Polydexa with PE produced a more homogeneous and finely dispersed spray than generic. Comparison of the shape and area of the spraying track on a planar simulation model showed a wide but uneven spraying of generic and a narrow, dense and homogenous one of Polydexa with PE. Key words: nasal spray, silicone nose model, shadow photography, spraying characteristics, neomycin, polymyxin B, dexamethasone, phenylephrine