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首页> 外文期刊>Powder Technology: An International Journal on the Science and Technology of Wet and Dry Particulate Systems >Optimizing aerosolization efficiency of dry-powder aggregates of thermally-sensitive polymeric nanoparticles produced by spray-freeze-drying
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Optimizing aerosolization efficiency of dry-powder aggregates of thermally-sensitive polymeric nanoparticles produced by spray-freeze-drying

机译：优化通过喷雾冷冻干燥制得的热敏聚合物纳米颗粒的干粉聚集体的雾化效率

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摘要

Dry powder inhaler (DPI) delivery of therapeutic nanoparticles requires the nanoparticles to be transformed into inhalable micro-scale aggregate structures (i.e. nano-aggregates). The present work details the spray-freeze-drying (SFD) production of dry-powder aggregates of thermally-sensitive polymeric nanoparticles. Specifically, the aim is to optimize the aerosolization efficiency of the nano-aggregates, while keeping the morphology, production yield, flowability, and aqueous reconstitution in the desirable range. For this purpose, the effects of SFD process parameters (i.e. atomization rate, feed concentration, and feed rate) and freeze-drying adjuvant formulation on the nano-aggregate characteristics are examined. Low melting-point poly (caprolactone) (PCL) nanoparticles are used as the model nanoparticles. Mannitol and leucine are used as the hydrophilic and hydrophobic adjuvants, respectively. Large spherical porous nano-aggregates, where PCL nanoparticles are physically dispersed in the porous adjuvant matrix, have been produced. The presence of mannitol is crucial in ensuring that the nano-aggregates readily reconstitute into individual nanoparticles upon exposure to an aqueous environment, so that they can perform their intended therapeutic functions. The presence of leucine, on the other hand, is mandatory to obtain high aerosolization efficiency as its presence reduces the nano-aggregate tendency to agglomerate. At the optimal condition, nano-aggregates exhibiting ED (Emitted Dose)≈95%, FPF (Fine Particle Fraction)≈30%, and MMAD (Mass Median Aerodynamic Diameter) ≈5.3 μm, which are comparable to the values obtained in commercial DPI, have been produced. The results signify the potential of SFD to be employed in the production of inhalable dosage form of thermally-sensitive therapeutic nanoparticles.
机译：治疗性纳米颗粒的干粉吸入器（DPI）递送要求将纳米颗粒转化为可吸入的微型聚集体结构（即纳米聚集体）。本工作详细介绍了热敏聚合物纳米颗粒的干粉聚集体的喷雾冷冻干燥（SFD）生产。具体地，目的是优化纳米聚集体的雾化效率，同时将形态，生产产率，流动性和水重构保持在期望的范围内。为此目的，检查了SFD工艺参数（即雾化速率，进料浓度和进料速率）和冷冻干燥助剂制剂对纳米聚集体特性的影响。低熔点聚己内酯（PCL）纳米颗粒用作模型纳米颗粒。甘露醇和亮氨酸分别用作亲水性和疏水性佐剂。已经生产出大的球形多孔纳米聚集体，其中PCL纳米颗粒物理分散在多孔佐剂基质中。甘露醇的存在对于确保纳米聚集体在暴露于水性环境后能容易地重构为单个纳米颗粒，从而使其能够执行其预期的治疗功能至关重要。另一方面，亮氨酸的存在是获得高雾化效率所必需的，因为它的存在降低了纳米聚集体的凝聚趋势。在最佳条件下，纳米聚集体的ED（发射剂量）≈95％，FPF（细颗粒分数）≈30％和MMAD（质量平均空气动力学直径）≈5.3μm，与商业DPI获得的值相当，已产生。结果表明SFD在生产热敏治疗性纳米颗粒可吸入剂型中的潜力。

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