Dalla-Bona Alexandra C, Schmehl Thomas, Gessler Tobias, Seeger Werner, Beck-Broichsitter Moritz
a Department of Internal Medicine , Medical Clinic II, Justus-Liebig-Universität , Giessen , Germany.
Drug Dev Ind Pharm. 2015;41(10):1704-9. doi: 10.3109/03639045.2014.993399. Epub 2014 Dec 18.
The process of vibrating-mesh nebulization is affected by sample physicochemical properties. Exemplary, electrolyte supplementation of diverse formulations facilitated the delivery of adequate aerosols for deep lung deposition.
This study addressed the impact of storage conditions of poly(lactide-co-glycolide) nanosuspension on aerosol properties when nebulized by the eFlow®rapid.
First, purified nanosuspensions were supplemented with electrolytes (i.e. sodium chloride, lactic and glycolic acid). Second, the degradable nanoparticles (NP) were incubated at different temperatures (i.e. 4, 22 and 36 °C) for up to two weeks. The effect of formulation supplementation and storage on aerosol characteristics was studied by laser diffraction and correlated with the sample conductivity.
Nebulization of purified nanosuspensions resulted in droplet diameters of >7.0 µm. However, electrolyte supplementation and storage, which led to an increase in sample conductivity (>10-20 µS/cm), were capable of providing smaller droplet diameters during vibrating-mesh nebulization (≤5.0 µm). No relevant change of NP properties (i.e. size, morphology, remaining mass and molecular weight of the employed polymer) was observed when incubated at 22 °C for two weeks.
Sample aging is an alternative to electrolyte supplementation in order to ameliorate the aerosol characteristics of degradable NP formulations when nebulized by vibrating-mesh technology.
振动网式雾化过程受样品物理化学性质影响。例如，不同配方的电解质补充有助于产生足够的气溶胶以实现肺部深部沉积。
本研究探讨了聚（丙交酯-共-乙交酯）纳米混悬液在通过eFlow®rapid雾化时储存条件对气溶胶性质的影响。
首先，向纯化的纳米混悬液中补充电解质（即氯化钠、乳酸和乙醇酸）。其次，将可降解纳米颗粒（NP）在不同温度（即4、22和36°C）下孵育长达两周。通过激光衍射研究配方补充和储存对气溶胶特性的影响，并与样品电导率相关联。
纯化纳米混悬液的雾化产生的液滴直径>7.0μm。然而，电解质补充和储存导致样品电导率增加（>10 - 20μS/cm），这能够在振动网式雾化过程中提供较小的液滴直径（≤5.0μm）。当在22°C下孵育两周时，未观察到NP性质（即所用聚合物的尺寸、形态、剩余质量和分子量）的相关变化。
样品老化是一种替代电解质补充的方法，可改善可降解NP配方在通过振动网式技术雾化时的气溶胶特性。
