Leung Sharon Shui Yee, Chiow Adam Chong Ming, Ukkonen Ari, Chan Hak-Kim
Faculty of Pharmacy, The University of Sydney, Sydney, NSW 2006, Australia.
Dekati Ltd., Tykkitie 1, FIN-36240, Kangasala, Finland.
Pharm Res. 2016 Feb;33(2):283-91. doi: 10.1007/s11095-015-1786-z. Epub 2015 Sep 3.
To investigate the applicability of Bipolar Charge Analyzer (BOLAR), a new commercial instrument developed by Dekati Ltd., in simultaneously characterizing the bipolar electrostatic charge profile and measuring the size distribution of commercial metered dose inhalers (MDIs).
Intal Forte(®) (sodium cromoglycate), Tilade(®) (nedocromil sodium), Ventolin(®) (salbutamol sulphate), and QVAR(®) (beclomethasone dipropionate) were used as model MDIs in this study. Three individual actuations of each MDI were introduced into the BOLAR at an air flow rate of 60 l/min. Charge and mass profiles for each actuation were determined.
The BOLAR was found to have better performance in collecting valid charge data (≥80%) than valid mass data (≥50%). In all tested products, both positively and negatively charged particles were found in five defined size fractions between zero and 11.6 μm, with the charge magnitude decreased with increasing particle size. The net charge profiles obtained from the BOLAR qualitatively agreed with the results reported previously. In all suspension type MDIs, negligible masses were detected in the smallest size fraction (<0.95 μm), for which the charge was most likely caused by the propellant and excipients. QVAR was the only solution MDI tested and the charge and mass profiles were significantly different from the suspension-type MDIs. Its mass profile was found to follow closely with the charge profile.
Positively and negatively charged MDI particles of different size fractions and their corresponding charge-to-mass profiles were successfully characterized by the BOLAR.
研究由德卡蒂有限公司开发的新型商用仪器双极电荷分析仪（BOLAR）在同时表征商用定量吸入器（MDIs）的双极静电荷分布和测量其粒径分布方面的适用性。
本研究中使用因他福特（®）（色甘酸钠）、替乐（®）（奈多罗米钠）、万托林（®）（硫酸沙丁胺醇）和辅舒酮（®）（丙酸倍氯米松）作为MDIs的模型。将每个MDI的三次单独喷雾以60升/分钟的气流速率引入BOLAR中。确定每次喷雾的电荷和质量分布。
发现BOLAR在收集有效电荷数据（≥80%）方面比有效质量数据（≥50%）具有更好的性能。在所有测试产品中，在0至11.6微米的五个定义粒径分数中均发现了带正电和带负电的颗粒，电荷大小随粒径增大而减小。从BOLAR获得的净电荷分布在质量上与先前报道的结果一致。在所有混悬型MDIs中，在最小粒径分数（<0.95微米）中检测到的质量可忽略不计，其电荷很可能由推进剂和赋形剂引起。辅舒酮是唯一测试的溶液型MDI，其电荷和质量分布与混悬型MDIs显著不同。发现其质量分布与电荷分布密切相关。
BOLAR成功地表征了不同粒径分数的带正电和带负电的MDI颗粒及其相应的电荷-质量分布。
