Evaluation of Spray Characteristics of Suspension Nasal Sprays
The droplet size distribution was measured by the laser particle size measurement system,while the spray pattern and plume geometry were measured by SprayVIEW laser imaging system.The spray performances of two kinds of suspension nasal sprays between the original drugs and the generic drugs were compared.Additionally,the consistency of spray performances between different batches of the samples from 4 companies(A,B,C,D)was analyzed in this study.The results showed that d(0.5)was in the range of 27-51 μm.The droplet size distribution results of the products from companies A and B,C and D were different.The intra-and inter-batch variabilities of the droplet size distribution of nasal sprays from companies A and D were less than those of the products from companies B and C,respectively.The spray area showed a significant difference between the original drugs and the generic drugs.The plume geometry results of the products from companies A and B,C and D were similar.The cross section of the spray was nearly circular with elliptical rate of 1.13 to 1.41.The spray performance results of the products from the original drugs and the generic drugs were different.Therefore,it was necessary to strengthen the investigation on detection methods of the spray performances and comparison study of different products in the development of nasal spray products.