Innovative Production of Diclofenac Sodium-Loaded Solid Lipid Nanoparticles by Membrane Nanoprecipitation: Evaluation of Encapsulation Efficiency and Photoprotection Ability.

IF 4.1 3区医学 Q2 CHEMISTRY, MULTIDISCIPLINARY

Pharmaceutical Research Pub Date : 2026-08-01 Epub Date: 2026-06-19 DOI:10.1007/s11095-026-04139-8

Fabio Bazzarelli, Giuseppina Ioele, Martina Chieffallo, Lidietta Giorno, Antonio Garofalo, Alessio Fuoco, Emma Piacentini

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引用次数: 0

Abstract

Purpose: The stability of diclofenac sodium (DS) in liquid formulation is influenced by environmental factors such as temperature, humidity and light. The encapsulation of this drug in solid lipid nanoparticles (SLNs) can offer a useful strategy to protect it from degradation. The present study shows the potential of membrane nanoprecipitation (MN) as a productive and advantageous method for the formulation of cocoa butter-based SLNs to improve the photostability of DS.

Methods: Conventional batch nanoprecipitation and MN were explored by varying the formulation parameters and process conditions to obtain SLNs.

Results: The MN produced SLNs with an average size of 421 ± 14 nm, a high encapsulation efficiency of 95 ± 3.2%, and a drug loading of 8.8 ± 0.2%, when an acetate buffer at pH 4.1 was used as the non-solvent phase. Chemical characterization of the proposed formulation was performed by DSC and FTIR analyses. The efficacy of SLNs in preserving DS stability was investigated under simulated sunlight exposure, demonstrating a residual drug concentration of 90% after 3.34 min with respect to the aqueous solution that showed the same concentration value after 0.072 min.

Conclusions: Overall, MN represents a suitable and sustainable process for the continuous production of light-stable drug-loaded SLNs.

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膜纳米沉淀法创新生产双氯芬酸钠负载固体脂质纳米颗粒：包封效率和光保护能力的评价。

目的：考察温度、湿度、光照等环境因素对双氯芬酸钠液体制剂稳定性的影响。将该药物包封在固体脂质纳米颗粒（sln）中可以提供一种有效的策略来保护其免受降解。本研究表明，膜纳米沉淀法（MN）是一种高效且有利的方法，可用于制备可可脂基sln，以提高DS的光稳定性。方法：通过改变配方参数和工艺条件，探索常规间歇纳米沉淀法和MN法制备单晶硅纳米粒子。结果：以pH 4.1的醋酸缓冲液为非溶剂相时，MN制备的sln平均粒径为421±14 nm，包封率为95±3.2%，载药量为8.8±0.2%。通过DSC和FTIR分析对该制剂进行了化学表征。在模拟阳光照射下研究了sln保持DS稳定性的效果，结果表明，在3.34 min后，sln相对于水溶液的残留药物浓度为90%，而在0.072 min后，sln的残留药物浓度保持在相同的浓度值。结论：总的来说，MN是一种适合连续生产光稳定载药sln的可持续工艺。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pharmaceutical Research 医学-化学综合

CiteScore

6.60

自引率

5.40%

发文量

276

审稿时长

3.4 months

期刊介绍： Pharmaceutical Research, an official journal of the American Association of Pharmaceutical Scientists, is committed to publishing novel research that is mechanism-based, hypothesis-driven and addresses significant issues in drug discovery, development and regulation. Current areas of interest include, but are not limited to: -(pre)formulation engineering and processing- computational biopharmaceutics- drug delivery and targeting- molecular biopharmaceutics and drug disposition (including cellular and molecular pharmacology)- pharmacokinetics, pharmacodynamics and pharmacogenetics. Research may involve nonclinical and clinical studies, and utilize both in vitro and in vivo approaches. Studies on small drug molecules, pharmaceutical solid materials (including biomaterials, polymers and nanoparticles) biotechnology products (including genes, peptides, proteins and vaccines), and genetically engineered cells are welcome.