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首页> 外文期刊>Journal of drug delivery science and technology >Evaluation of the impact of critical quality attributes and critical process parameters on quality and stability of parenteral nutrition nanoemulsions
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Evaluation of the impact of critical quality attributes and critical process parameters on quality and stability of parenteral nutrition nanoemulsions

机译：评价临界质量属性和关键过程参数对肠胃外营养纳米乳液质量和稳定性的影响

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The aim of this study was to develop, characterize and evaluate concentrated nanoemulsions (20%) for parenteral nutrition. Those systems were developed by the high-pressure homogenization method. Optimal conditions for the nanoemulsion production were identified using 2(4-1) fractional factorial design. The characterization of physicochemical parameters was carried out immediately after the nanoemulsion production, and after 10 and 30 days. The biological control was conducted 30 days after their preparation as well. The oil phase contained the combination of the soybean (SO) and fish oil (FO) as well as the fish oil and medium-chain triglycerides (MCT), while the aqueous phase was composed of water for injections. The egg yolk phospholipids (EP) were used as surfactants alone, or in combination with Poloxamer 188 (PI). The obtained results were in accordance with the literature date e.i. quality requirements for parenteral emulsions (the droplet diameter <= 500 nm, PDI <= 0.25, absolute value of zeta-potential >= 25 mV, pH-value in the range of 6-9). It was shown that the combination of two surfactants (the egg yolk phospholipids that provides the electrostatic stabilization and Poloxamer 188-steric stabilizer) used as emulsifiers ensures the optimal quality of the obtained nanoemulsions for parenteral nutrition. (C) 2017 Elsevier B.V. All rights reserved.
机译：本研究的目的是发展，表征和评估肠胃外营养的浓缩纳米乳液（20％）。这些系统是由高压均质化方法开发的。使用2（4-1）分数阶段设计鉴定了纳米乳液产生的最佳条件。在纳米乳液生产后立即进行物理化学参数的表征，并在10和30天后进行。生物控制也在制备后30天进行。油相含有大豆（SO）和鱼油（FO）以及鱼油和中链甘油三酯（MCT）的组合，而水相由注射水组成。蛋黄磷脂（EP）用作单独的表面活性剂，或与泊洛沙姆188（PI）组合。获得的结果符合文献日e.i。肠胃外乳液的质量要求（液滴直径<= 500nm，PDI <= 0.25，ζ-电位的绝对值> = 25mV，pH值范围为6-9）。结果表明，两种表面活性剂（提供静电稳定化和泊洛沙姆188-立体稳定剂的蛋黄磷脂）的组合确保了所得纳米乳液的最佳质量用于肠胃外营养。 （c）2017 Elsevier B.v.保留所有权利。

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