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Quality-by-Design approach to the fluid-bed coating of ginkgo lactone nanosuspensions
RSC Advances ( IF 3.9 ) Pub Date : 2018-06-15 00:00:00 , DOI: 10.1039/c8ra03288b
Jiawei Han 1, 2 , Xin Wang 1, 2 , Jingxian Wang 1, 2 , Lingchong Wang 1, 2 , Lihua Chen 3 , Junsong Li 1, 2 , Wen Li 1
Affiliation  

The Quality-by-Design (QbD) approach was employed to investigate the fluid-bed coating process for the conversion of ginkgo lactone (GL) liquid nanosuspensions into dried nanosuspensions. The effects of critical process variables including inlet air temperature, inlet air capacity and atomizing air pressure were investigated. The particle size and percent yield were optimized using a full factorial design. A Box-Behnken design (BBD) was employed to generate the response surface and optimize process conditions. Multi-linear regression and one-way ANOVA were used to analyze the relationship between critical variables and responses. The results showed that all three selected variables were significant factors (p < 0.05) affecting the particle size. Higher inlet temperature, inlet air capacity or atomizing air pressure will cause an increase of particle size. In addition, the percent yield primarily depended on the inlet air temperature and inlet air capacity (p < 0.05). A higher percent yield was obtained at a higher inlet air temperature or inlet air capacity. The optimal conditions for BBD, including inlet air temperature, inlet air capacity and atomizing air pressure, were set at 40 °C, 11.6 Nm3 and 0.7 bar, respectively. Compared with the raw GLs, the optimized products presented an amorphous state and possessed much faster dissolution. The particle size, percent yield, PDI, zeta-potential and redispersibility index of the optimized products were 254.3 ± 9.8 nm, 82.36 ± 1.87%, 0.155 ± 0.02, −32.9 ± 3.8 mV and 113 ± 4.4% (n = 3), respectively. These results indicate that fluid-bed coating technology based on a QbD approach was sufficient for the solidification of nanosuspensions.

中文翻译:

银杏内酯纳米混悬剂流化床包衣的质量源于设计方法

质量源于设计 (QbD) 方法用于研究将银杏内酯 (GL) 液体纳米悬浮液转化为干燥纳米悬浮液的流化床包衣工艺。研究了关键过程变量的影响,包括入口空气温度、入口空气容量和雾化空气压力。使用全因子设计优化粒度和产率百分比。采用 Box-Behnken 设计 (BBD) 来生成响应面并优化工艺条件。多元线性回归和单因素方差分析用于分析关键变量和响应之间的关系。结果表明,所有三个选定变量都是显着因素(p< 0.05) 影响粒径。较高的入口温度、入口空气容量或雾化空气压力会导致颗粒尺寸增加。此外,产率百分比主要取决于进气温度和进气容量(p < 0.05)。在更高的入口空气温度或入口空气容量下获得更高的产率百分比。BBD的最佳条件,包括入口空气温度、入口空气容量和雾化空气压力,设置为40°C,11.6 Nm 3和 0.7 巴,分别。与原始 GLs 相比,优化后的产品呈现无定形状态,溶解速度更快。优化后产品的粒径、收率、PDI、zeta电位和再分散指数分别为254.3±9.8 nm、82.36±1.87%、0.155±0.02、-32.9±3.8 mV和113±4.4%(n =3),分别。这些结果表明,基于 QbD 方法的流化床涂层技术足以固化纳米悬浮液。
更新日期:2018-06-15
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