Objective: To determine spray pattern, plume geometry and delivered dose of the reference products and the tested products of salbutamol sulfate inhalation aerosol, and judge the atomization characteristic equivalence in vitro of the reference and test products. Methods: Spray pattern and plume geometry of salbutamol sulfate inhalation aerosol were determined by Spray VIEW. Plume geometry was evaluated with plume angle and plume width. Spray pattern was evaluated with spray area and ovality. The results were analyzed by population bioequivalence (PBE).Combined with the results of delivered dose, equivalence in vitro of the reference products and the tested products was further judged. Results: The ratios of the average of the geometric mean of plume angle of the reference and the test products were 98.2%(3 cm), 97.1%(6 cm), respectively, and the average of the geometric mean of plume width were 97.4%(3 cm) and 98.4%(6 cm), respectively. The spray area, ovality, plume angle and plume width at 3 cm and 6 cm were analyzed by PBE. The upper limits of the 95% confidence interval of ovality were -0.02(3 cm) and -0.02(6 cm), respectively. The upper limits of the 95% confidence interval of spray area were -0.01 (3 cm) and -0.02 (6 cm), respectively. The upper limits of the 95% confidence interval of plume angle were -0.02(3 cm) and-0.02(6 cm), respectively. The upper limits of the 95% confidence interval of plume width were-0.02(3 cm) and -0.02(6 cm), respectively. The delivered dose of the reference products and the test products were different, and the delivered dose of the test products was more uniform. Conclusion: The reference and the test products are equivalent in spray pattern and plume geometry, but the uniformity of delivery dose is non-equivalent by nonparametric test. It provides choices for the formulation, process and atomization device screening of generic products, offers the evaluation method of atomization characteristic in vitro, and provides ideas for the development and evaluation in vitro of generic products.
CHANG Jie, WEI Ning-yi, GENG Ying, ZHOU Ying, WANG Zhen, NING Bao-ming
. Determination of spray pattern and plume geometry of salbutamol sulfateinhalation aerosol and analysis of population bioequivalence[J]. Chinese Journal of Pharmaceutical Analysis, 2023
, 43(5)
: 771
-779
.
DOI: 10.16155/j.0254-1793.2023.05.07
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