Boc Susan, Momin Mohammad A M, Farkas Dale R, Longest Worth, Hindle Michael
Department of Pharmaceutics, Virginia Commonwealth University, Richmond, Virginia, USA.
Department of Mechanical & Nuclear Engineering, Virginia Commonwealth University, Richmond, Virginia, USA.
AAPS PharmSciTech. 2021 Apr 15;22(4):135. doi: 10.1208/s12249-021-01998-9.
Efficient delivery of dry powder aerosols dispersed with low volumes of air is challenging. This study aims to develop an efficient dry powder inhaler (DPI) capable of delivering spray-dried Survanta-EEG powders (3-10 mg) with a low volume (3 mL) of dispersion air. A series of iterative design modifications were made to a base low air volume actuated DPI. The modifications included the replacement of the original capsule chamber with an integral dose containment chamber, alteration of the entrainment air flow path through the device (from single-sided (SS) to straight through (ST)), change in the number of air inlet holes (from one to three), varying the outlet delivery tube length (45, 55, and 90 mm) and internal diameter (0.60, 0.89, and 1.17 mm). The modified devices were evaluated by determining the influence of the modifications and powder fill mass on aerosol performance of spray-dried Survanta-EEG powders. The optimal DPI was also evaluated for its ability to aerosolize a micronized powder. The optimized dose containment unit DPI had a 0.21 mL powder chamber, ST airflow path, three-0.60 mm air inlet holes, and 90 mm outlet delivery tube with 0.89 mm internal diameter. The powder dispersion characteristics of the optimal device were independent of fill mass with good powder emptying in one 3 mL actuation. At 10 mg fill mass, this device had an emitted mass of 5.3 mg with an aerosol Dv50 of 2.7 μm. After three 3 mL actuations, >85% of the spray-dried powder was emitted from the device. The emitted mass of the optimal device with micronized albuterol sulfate was >72% of the nominal fill mass of 10 mg in one 3 mL actuation. Design optimization produced a DPI capable of efficient performance with a dispersion air volume of 3 mL to aerosolize Survanta-EEG powders.
以低空气量分散干粉气雾剂的高效递送具有挑战性。本研究旨在开发一种高效的干粉吸入器（DPI），能够以低体积（3 mL）的分散空气递送喷雾干燥的Survanta-EEG粉末（3 - 10 mg）。对一种基于低空气量驱动的DPI进行了一系列迭代设计修改。修改包括用一体式剂量容纳腔替换原来的胶囊腔，改变通过该装置的夹带空气流动路径（从单侧（SS）改为直通（ST）），改变进气孔数量（从一个改为三个），改变出口输送管长度（45、55和90 mm）以及内径（0.60、0.89和1.17 mm）。通过确定这些修改和粉末填充质量对喷雾干燥的Survanta-EEG粉末气溶胶性能的影响，对改进后的装置进行了评估。还评估了最佳DPI雾化微粉化粉末的能力。优化后的剂量容纳单元DPI具有0.21 mL的粉末腔、ST气流路径、三个0.60 mm的进气孔以及内径为0.89 mm的90 mm出口输送管。最佳装置的粉末分散特性与填充质量无关，在一次3 mL驱动中粉末排空良好。在填充质量为10 mg时，该装置的喷出质量为5.3 mg，气溶胶Dv50为2.7 μm。经过三次3 mL驱动后，>85%的喷雾干燥粉末从装置中喷出。对于微粉化硫酸沙丁胺醇，最佳装置在一次3 mL驱动中的喷出质量>10 mg标称填充质量的72%。设计优化产生了一种DPI，能够以3 mL的分散空气量高效地雾化Survanta-EEG粉末。
