Spray characteristics between generic and original azelastine hydrochloride nasal spray
Objective To evaluate consistency in the spray characteristics(droplet size distribution,spray pattern,and plume geometry)of the original and generic azelastine hydrochloride nasal sprays.Methods The particle size distribution,spray pattern and plume geometry were determined by laser particle size analyzer and SprayVIEW laser Imaging system,respectively.Results The ovality ratio of the original and generic drugs detected at 6 cm distance were(1.152±0.052)vs(1.306±0.049);the spray area were(490.3±43.6)mm2 vs(365.6±55.5)mm2;the spray angle were(25.5±1.9)° vs(22.4±1.0)°;the D50 and D90 were(45.01±1.81)μm vs(57.39±3.39)μm,and(81.93±6.83)μm vs(146.47±14.05)μm,having significant differences(P＜0.05),respectively.Conclusion The original drug of azelastine hydrochloride nasal spray has a good spraying characteristics.The generic drug needs improvement.
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