首页> 美国卫生研究院文献>AAPS PharmSciTech >Box-Behnken experimental design in the development of a nasal drug delivery system of model drug hydroxyurea: Characterization of viscosity in vitro drug release droplet size and dynamic surface tension
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Box-Behnken experimental design in the development of a nasal drug delivery system of model drug hydroxyurea: Characterization of viscosity in vitro drug release droplet size and dynamic surface tension

机译:在模型药物羟基脲鼻腔给药系统开发中的Box-Behnken实验设计:粘度体外药物释放液滴大小和动态表面张力的表征

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摘要

The purpose of the research was to investigate the changes in physicochemical properties and their influence on nasal formulation performance using 5-factor, 3-level Box-Behnken experimental design on the combined responses of viscosity, droplet size distribution (DSD), and drug release. Gel formulations of hydroxyurea (HU) with surface-active polymers (hydroxyethylcellulose [HEC] and polyethylene-oxide [PEO]) and ionic excipients (sodium chloride and calcium chloride) were prepared using Box-Behnken experimental design. The rheology and dynamic surface tension (DST) of the test formulations was investigated using LV-DV-III Brookfield rheometer and T60 SITA tensiometer, respectively. Droplet size analysis of nasal aerosols was determined by laser diffraction using the Malvern Spraytec with the InnovaSystems actuator. In vitro drug release studies were conducted on Franz diffusion cells. With PEO gel, calcium chloride increased the viscosity and DSD and retarded drug release, while sodium chloride decreased the viscosity, DST, and DSD and accelerated the release of HU. With HEC gel, the addition of the above salts resulted in less significant changes in viscosity, DSD, and DST, but both salts significantly increased the release of HU. Droplet size data obtained from a high viscosity nasal pump was dependent on type of polymer, polymer-excipient interactions, and solvent properties. The applications of Box-Behnken experimental design facilitated the prediction and identified major excipient influences on viscosity, DSD, and in vitro drug release.
机译:该研究的目的是使用粘度,液滴尺寸分布(DSD)和药物释放的组合响应的五因素,三级Box-Behnken实验设计来研究理化性质的变化及其对鼻剂性能的影响。使用Box-Behnken实验设计制备了具有表面活性聚合物(羟乙基纤维素[HEC]和聚环氧乙烷[PEO])和离子型赋形剂(氯化钠和氯化钙)的羟基脲(HU)凝胶制剂。分别使用LV-DV-III Brookfield流变仪和T60 SITA张力仪研究了测试制剂的流变学和动态表面张力(DST)。使用带有InnovaSystems执行器的Malvern Spraytec,通过激光衍射测定鼻气溶胶的液滴大小。在Franz扩散池上进行了体外药物释放研究。使用PEO凝胶时,氯化钙增加了粘度和DSD并延缓了药物的释放,而氯化钠降低了粘度,DST和DSD并加速了HU的释放。使用HEC凝胶时,上述盐的添加导致粘度,DSD和DST的变化较小,但两种盐均显着增加了HU的释放。从高粘度鼻泵获得的液滴尺寸数据取决于聚合物的类型,聚合物与赋形剂的相互作用以及溶剂的性质。 Box-Behnken实验设计的应用有助于预测并确定主要的赋形剂对粘度,DSD和体外药物释放的影响。

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