Agglomerate strength and dispersion of pharmaceutical powders

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• 作者：Santoso Adi^a ; Handoko Adi^a ; Hak-Kim Chan^a ; ^{kim.chan@sydney.edu.au} ; Warren H. Finlay^b ; Zhenbo Tong^c ; Runyu Yang^c ; Aibing Yu^c
• 关键词：Agglomerate strength ; Mannitol ; Dry powder inhalation ; Aerosol ; Storage humidity
• 刊名：Journal of Aerosol Science
• 出版年：2011
• 出版时间：April 2011
• 年：2011
• 卷：42
• 期：4
• 页码：285-294
• 全文大小：898 K

文摘

This study aims to investigate quantitatively the direct correlation between the mechanical strength of powder agglomerates and their dispersion into aerosols by a dry powder inhaler. Agglomerates of mannitol as a model drug-only formulation were prepared by a rolling method followed by exposure to various relative humidity (RH: 55 % , 82 % , 86 % and 90 % ). The agglomerate strength was obtained from the compression of single agglomerates at a selected speed rate using an Instron testing machine. The dispersion performance (FPF_Loaded) was determined at flow rates of 60 and 100 l min⁻¹ using an Aeroliser^® coupled to a multistage liquid impinger. Results showed an inverse linear relationship between the agglomerate strength and the dispersion performance. An increase in strength from 3 to 183 kPa resulted in a significant drop (P<0.05) of 18 % in the FPF_Loaded. Agglomerates containing ‘solid bridges’ exhibited higher strength (three to eight times) and lower FPF (5–15 % , corresponding to 86 % and 90 % RH) compared to those containing ‘liquid bridges’. These results have provided direct information on the agglomerate strength and its quantitative relationship with powder aerosol performance.