Assessment of inter-series reproducibility of parameters reflecting spraying quality of five oral sprays
Local antiseptics play an important role in the treatment of inflammatory diseases of the upper respiratory tract in children. There are many pharmaceutical forms of antiseptics, but doctors often recommend sprays, because they are easy to use, cost-effective, and ensure rapid effect. There is a large number of similar sprays under different brand names, which often makes it difficult to choose a drug. The stability of spraying parameters, such as dose mass and print area on a planar simulation model, appears to be a good additional criterion in for choosing an oral spray. Objective. To compare inter-series reproducibility of the dose mass and the area of the print on a planar simulation model of five benzydamine containing oral sprays in order to identify the spray with the most stable spraying parameters. Materials and methods. We evaluated five oral sprays (5 series for each) used for the treatment of inflammatory diseases of the upper respiratory tract in pediatric practice: Angidak, Zvezdochka Lor, Oralsept, Septolete Total, and Tantum Verde. We tested these sprays using planar simulation models, namely filter paper impregnated with Dragendorf reagent. The ELECTRONIC BALANCE B2104 electronic scales were used in assessing the reproducibility of the dose mass. Results. In this study, we evaluated inter-series reproducibility of the dose mass and cone characteristics for five oral sprays. To assess reproducibility, we calculated means, standard errors (%), and dispersion. Standard errors for the dose mass were as follows: 2%-3% for Tantum Verde and Septolete Total and 5%-8% for Oralsept, Zvezdochka Lor, and Angidak. The stability of the spray cone geometry was characterized by the reproducibility of the print area after spraying a single dose of the drug on a planar simulation model. The print areas were evaluated for five series of each spray. The reproducibility of the print area (standard error) was 3%-4% for Septolete Total and Tantum Verde, 10% for Oralsept, and more than 10% for Zvezdochka Lor and Angidak. Conclusion. We evaluated inter-series reproducibility of two parameters reflecting the quality of spraying (dose mass and print area on a planar simulation model) for five oral sprays. The best inter-series reproducibility was demonstrated by Septolete Total and Tantum Verde, which indicates better stability of the spraying systems used in these two drugs.