Number-concentration of nanoparticles in liposomal and polymeric multiparticulate preparations: Empirical and calculation methods
Number-concentration of nanoparticles in liposomal and polymeric multiparticulate preparations: Empirical and calculation methods
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DOI：
10.1016/j.biomaterials.2005.06.006
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发表时间：
2006-02-01
期刊：
影响因子：
14
通讯作者：
Golomb, G
中科院分区：
文献类型：
--
作者：
Epstein, H;Afergan, E;Golomb, G
纳米颗粒制剂中的实际颗粒数对于质量保证、综合理化表征和药效学具有重要意义。以前采用的一些计算方法是有限的，因为它们依赖于几个假设，不适用于某些制剂。目前还没有经过验证的实验方法来确定脂质体和聚合物纳米颗粒制剂（< 500 nm）的颗粒数-浓度（N-c）。本研究探讨了一种新的经验方法，用于计算纳米颗粒制剂中的颗粒数，包括含药物的脂质体和聚合物NP。在新的方法中，悬浮的NP被雾化形成气溶胶液滴，该气溶胶液滴被干燥并使用扫描迁移率粒度仪（SMPS）计数。用三种不同的制剂进行实验，空脂质体（200和400 nm）、载药脂质体（200 nm）和聚合物NP（150 nm）。经证实，SMPS技术未诱导制剂的有害形态或结构变化，并且所获得的N-c1值代表原始颗粒。可以得出结论，浓度高达每1cm（3）空气10个颗粒（对应于每1 ml溶液约10（12）个颗粒）的纳米制剂可以在30-900 nm的尺寸范围内直接计数。将测量值与新开发的理论计算进行比较，以评估这些计算的可行性。(c)2005爱思唯尔有限公司保留所有权利。
The actual number of particles in formulations of nanoparticles (NP) is of importance for quality assurance, comprehensive physicochemical characterization, and pharmacodynamics. Some calculation methods that have been previously employed are limited because they rely on several assumptions and are not applicable for certain preparations. Currently there are no validated experimental methods for determining the particle number-concentration (N-c)of liposomal and polymeric nanoparticulate preparations (< 500 nm). This study examines a new empirical method for counting the number of particles in nanoparticulate formulations including drug-containing liposomes and polymeric NP. In the new method, suspended NP are nebulized to form aerosol droplets which are dried and counted using a scanning mobility particle sizer (SMPS). Experiments were conducted with three different preparations, empty liposomes (200 and 400 nm), drug-loaded liposomes (200 nm), and polymeric NP (150 nm). It was verified that no detrimental morphological or structural changes of the formulations have been induced by the SMPS technique, and that the obtained N-c, values represent the original particles. It is concluded that nano-formulations with concentrations of up to 10, particles per 1 cm(3) air, corresponding to approximately 10(12) particles per 1 ml solution, can be directly counted within the size range of 30-900 nm. The measured values are compared to newly developed theoretical calculations to assess the viability of these calculations. (c) 2005 Elsevier Ltd. All rights reserved.