Optical Microscopy as a Tool for Assessing Parenteral Nutrition Solution Stability: A Proof of Concept.

IF 4.3 3区 医学 Q2 CHEMISTRY, MEDICINAL Pharmaceuticals Pub Date : 2024-10-05 DOI:10.3390/ph17101330
Luis Otero-Millán, Brais Bea-Mascato, Jose Luis Legido Soto, María Carmen Martín de la Cruz, Noemi Martínez-López-De-Castro, Natividad Lago-Rivero
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Abstract

Background/Objectives: Parenteral nutrition (PN) is used when enteral feeding is not possible. It is a complex mixture of nutrients that must meet a patient's needs but can face stability issues, such as lipid emulsion destabilisation and precipitate formation. Stability studies are complex, and the methodologies used are very varied in the literature. In addition, many studies are outdated and use outdated components. This study conducts a stability analysis of PN solutions using optical microscopy. Methods: Samples were prepared according to clinical practice standards and previous studies. We used a counting chamber for optical microscopic observations and different storage conditions (RT, 4 °C 1-14 days). Results: Precipitates larger than 5 µm were found in 8 out of 14 samples after 14 days of storage at room temperature, and none were observed in refrigerated samples. More lipid globules larger than 5 µm were detected in samples stored at room temperature than in those stored in a refrigerator after 14 days. Additionally, the number of large globules generally increased from day 1 to day 14 in most samples. Conclusions: The observed precipitates were probably calcium oxalate crystals, the formation of which is possible in PN but is not expected under the usual storage conditions in a hospital environment. Prolonged storage time and storage at room temperature increases the formation of these precipitates. These findings highlight the importance of using filters during both the preparation and administration of PN to prevent large particles from reaching patients.

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光学显微镜作为评估肠外营养液稳定性的工具:概念验证
背景/目的:肠外营养(PN)用于无法进行肠内喂养的情况。它是一种复杂的营养混合物,必须满足病人的需求,但也可能面临稳定性问题,如脂质乳液不稳定和沉淀形成。稳定性研究非常复杂,文献中使用的方法也多种多样。此外,许多研究已经过时,使用的成分也已经过时。本研究使用光学显微镜对 PN 溶液进行稳定性分析。方法:根据临床实践标准和以往研究制备样本。我们使用计数室进行光学显微观察,并采用不同的储存条件(RT、4 °C,1-14 天)。结果室温保存 14 天后,14 个样本中有 8 个样本中发现了大于 5 µm 的沉淀物,而冷藏样本中未发现沉淀物。在室温下保存 14 天的样品比在冰箱中保存 14 天的样品中检测到更多大于 5 微米的脂球。此外,从第 1 天到第 14 天,大多数样本中的大球数量普遍增加。结论:观察到的沉淀物可能是草酸钙结晶,在 PN 中可能会形成这种结晶,但在医院环境的通常储存条件下是不可能形成的。延长储存时间和在室温下储存会增加这些沉淀的形成。这些发现强调了在配制和给药过程中使用过滤器以防止大颗粒到达病人体内的重要性。
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来源期刊
Pharmaceuticals
Pharmaceuticals Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science
CiteScore
6.10
自引率
4.30%
发文量
1332
审稿时长
6 weeks
期刊介绍: Pharmaceuticals (ISSN 1424-8247) is an international scientific journal of medicinal chemistry and related drug sciences.Our aim is to publish updated reviews as well as research articles with comprehensive theoretical and experimental details. Short communications are also accepted; therefore, there is no restriction on the maximum length of the papers.
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