Determination and Consistency Analysis of Particle Size Distribution of Budesonide Nasal Spray / 中国药房

ABSTRACT

OBJECTIVE:To establish the method for the determination of particle size distribution of Budesonide nasal spray, and to analyze the consistency of particle size distribution of spray samples. METHODS:Water was used as dispersant for mixing and dispersing(1800 r/min). The particle sizes [d(0.1),d(0.5),d(0.9)] corresponded to accumulative particle size of 10%,50%and 90%were used as characteristic value. The distribution of granularity was determined by laser scattering method. The consisten-cy of particle size distribution of samples from 2 manufacturers (A,B) were analyzed among different batches or same batch of same manufacturer by SAS 9.3 statistical software. RESULTS:The mean values of d(0.1),d(0.5) and d(0.9) were 3.96 μm, 29.58 μm and 67.10 μm in manufacturer A. The mean values of d(0.1),d(0.5)and d(0.9)were 2.00 μm,7.53 μm and 28.51 μm in manufacturer B. By analysis,there was great difference in particle size of samples from 2 manufacturers. The particle size of the samples from manufacturer A were larger than that of manufacturer B. The consistency among different batches from manufacturer B was better,and the consistency among same batch were all good from 2 manufacturers. CONCLUSIONS:The established meth-od is suitable for particle size distribution of Budesonide nasal spray and the consistency analysis of particle size distribution.