Quality by design: characterization of self-nano-emulsified drug delivery systems (SNEDDs) using ultrasonic resonator technology.
Quality by design: characterization of self-nano-emulsified drug delivery systems (SNEDDs) using ultrasonic resonator technology.
复制标题
质量源于设计：使用超声谐振器技术表征自纳米乳化药物输送系统 (SNEDD)。
DOI：
10.1016/j.ijpharm.2007.04.009
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发表时间：
2007
影响因子：
5.8
通讯作者：
Mansoor A. Khan
中科院分区：
文献类型：
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作者：
R. Shah;Ahmed S. Zidan;T. Funck;M. Tawakkul;A. Nguyenpho;Mansoor A. Khan
在目前的工作中，详细介绍了超声波测量的一种新颖应用，以表征纳米乳液配方，作为总体质量源于设计 (QbD) 目标的一部分。利用超声波谐振器技术（URT）测量由不同比例的油：表面活性剂：助表面活性剂组成的自纳米乳化药物递送系统（SNEDD）的声速和吸收。 QbD 概念用于通过将环孢菌素 A 溶解在油中，利用甜橙油（油）、Emulphor-620（表面活性剂）和 Capmul（辅助表面活性剂）来创建不同的 SNEDD 配方。将混合物乳化在水中，并在超声波谐振器系统中等温地进行超声波测量，持续约15-20分钟。通过在单个谐振器频率下进行系统超声测量，研究了液滴中各个组分的可压缩性、液滴的水合以及成分对液滴稳定性的影响。使用 Urick 方程计算，油、水和界面组分的绝热压缩系数分别为 68、44.6 和 53 [10−11Pa−1]。此外，超声波吸收与纳米乳液的液滴尺寸呈线性相关，R2为0.84，表明这可以用作测量纳米乳液的液滴尺寸的附加技术。超声波数据与配方成分的相关性表明，超声波速度与配方中油量的增加以及表面活性剂与助表面活性剂的比率呈负相关，而液滴直径与这些配方因素呈正相关。从结果可以预见，介质的可压缩性随着油性成分的添加而增加，从而降低了声速。因此，URT能够直接、方便地分析纳米乳液的物理性质以及配方因素的影响，这是这些纳米乳液稳定性的重要指标。
In the present work, a novel application of ultrasonic measurements is detailed to characterize nano-emulsion formulations as a part of the overall Quality by Design (QbD) goal. Ultrasonic resonator technology (URT) was utilized to measure sound velocity and absorption of self-nanoemulsified drug delivery systems (SNEDDs) consisting of various ratios of oil:surfactant:co-surfactant. A QbD concept was used to create different SNEDDs formulations utilizing sweet orange oil (oil), Emulphor-620 (surfactant), and Capmul (co-surfactant) by dissolving Cyclosporine A in oil. The mixture was emulsified in water and ultrasonic measurements were carried out in an ultrasonic resonator system isothermally for a period of about 15–20min. Compressibility of the individual components in the droplets, hydration of the droplets and the influence of the composition on droplet stability were studied by systematic ultrasonic measurements at a single resonator frequency. The adiabetic compressibilities for the oil, aqueous and interfacial components were 68, 44.6, and 53 [10−11Pa−1], respectively as calculated using Urick's equation. Also the ultrasonic absorption correlated droplet size of nano-emulsions linearly with R2of 0.84 indicating this can be used as an additional technique to measure the droplet size of nano-emulsions. Correlation of ultrasonic data with formulation components indicated that the ultrasonic velocity correlated negatively with increasing oil amount in the formulation as well as surfactant-to-cosurfactant ratios where as droplet diameter correlated positively with these formulation factors. It can be envisioned from the results that the compressibility of the media increases with the addition of the oily component and thus reducing the sound velocity. Thus URT enabled direct and convenient analysis of the physical properties as well as influence of formulation factors of nano-emulsions which is an important indication of stability of these nano-emulsions.