QbD decorated ellagic acid loaded polymeric nanoparticles: Factors influencing desolvation method and preliminary evaluations

IF 5.45 Q1 Physics and Astronomy Nano-Structures & Nano-Objects Pub Date : 2024-10-31 DOI:10.1016/j.nanoso.2024.101378
Priya Patel , Ashish Thanki , Devesh U. Kapoor , Bhupendra G. Prajapati
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Abstract

Polymeric nanoparticles are one of the emerging drug delivery systems in the field of oncology. Ellagic acid is a polyphenolic compound with vast effects like anti-cancer, anti-viral, and anti-oxidant. The ellagic acid nanoparticles was prepared by desolvation method. Formulating ellagic acid NPs using BSA enhances the stability and solubility of ellagic acid. Quality by design (QbD) based approach was adopted to improve the final quality and effectiveness of the formulation. The Critical quality attribute (CQAs) was defined and risk assessment was performed with the help of the Ishikawa fishbone diagram. Solubility analysis was done for the drug with methanol, ethanol, water, and acetone. Preliminary studies were performed to study the effect of type of desolvating agent, the concentration of polymer the pH of the polymer solution, amount of desolvating agent on the particle size and entrapment efficiency of the nanoparticles. A greater quantity of desolvating agent results in a narrower particle size because of thorough desolvation, and the increased encapsulation efficiency is linked to reduced protein-protein interactions. Desolvation process can cause the protein to gradually change structure, form clumps, and eventually form nanoparticles, so might be its shows increase in entrapment efficiency. A desolvating agent volume of 4 ml resulted in a particle size of 1724 ± 1.27 nm. When the amount of desolvating agent was increased to 6 ml and 8 ml, the particle size decreased to 160 ± 0.66 nm and 218 ± 0.47 nm, respectively. Fourier Transform Infrared Spectroscopy (FTIR) data showed no incompatibilities were observed between drug and polymer. In-vitro dissolution showed the nanoparticles may follow the control release pattern over 24 hours. All the formulated batches of zeta potential were found to be in the range −30 mV to +30 mV which indicated good colloidal stability of the NPs and the PDI value ranging from 0.18 to 2.8. The higher drug encapsulation of the drug was more than 50 % which gives higher drug release at a site of action and in-vitro drug release of more than 80 % may improve the dosage frequency. The in vitro drug release data was also studied by various kinetic models. The in vitro drug release analysis shows sustained release of drug from nanoparticles and follow Korsmeyer-Peppas model. All these findings were in good agreement which may open a new gateway for future research in the field of oral oncology.
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QbD 装饰鞣花酸负载聚合物纳米颗粒:影响脱溶方法的因素及初步评估
聚合纳米粒子是肿瘤学领域新兴的给药系统之一。鞣花酸是一种多酚化合物,具有抗癌、抗病毒和抗氧化等多种功效。鞣花酸纳米粒子采用脱溶法制备。使用 BSA 配制鞣花酸 NPs 可提高鞣花酸的稳定性和可溶性。为提高制剂的最终质量和效果,采用了基于质量设计(QbD)的方法。在石川鱼骨图的帮助下,定义了关键质量属性(CQAs)并进行了风险评估。对药物在甲醇、乙醇、水和丙酮中的溶解度进行了分析。初步研究了脱溶剂的类型、聚合物的浓度、聚合物溶液的 pH 值、脱溶剂的用量对纳米颗粒的粒度和夹持效率的影响。脱溶剂用量越大,脱溶越彻底,粒径越窄,包封效率越高,这与蛋白质与蛋白质之间的相互作用减少有关。脱溶过程会使蛋白质逐渐改变结构,形成团块,最终形成纳米颗粒,因此可能会显示出包封效率的提高。脱溶剂用量为 4 ml 时,粒径为 1724 ± 1.27 nm。当脱溶剂的量增加到 6 毫升和 8 毫升时,粒径分别减小到 160 ± 0.66 nm 和 218 ± 0.47 nm。傅立叶变换红外光谱(FTIR)数据显示,药物和聚合物之间没有不相容现象。体外溶解显示,纳米颗粒可在 24 小时内遵循控制释放模式。所有配制批次的 zeta 电位都在 -30 mV 至 +30 mV 之间,这表明 NPs 具有良好的胶体稳定性,PDI 值在 0.18 至 2.8 之间。药物的封装率超过 50%,这使得药物在作用部位的释放率更高,体外药物释放率超过 80%,可提高用药频率。体外药物释放数据也通过各种动力学模型进行了研究。体外药物释放分析表明,药物从纳米颗粒中持续释放,并遵循 Korsmeyer-Peppas 模型。所有这些研究结果都非常吻合,为今后口腔肿瘤学领域的研究开辟了一条新途径。
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来源期刊
Nano-Structures & Nano-Objects
Nano-Structures & Nano-Objects Physics and Astronomy-Condensed Matter Physics
CiteScore
9.20
自引率
0.00%
发文量
60
审稿时长
22 days
期刊介绍: Nano-Structures & Nano-Objects is a new journal devoted to all aspects of the synthesis and the properties of this new flourishing domain. The journal is devoted to novel architectures at the nano-level with an emphasis on new synthesis and characterization methods. The journal is focused on the objects rather than on their applications. However, the research for new applications of original nano-structures & nano-objects in various fields such as nano-electronics, energy conversion, catalysis, drug delivery and nano-medicine is also welcome. The scope of Nano-Structures & Nano-Objects involves: -Metal and alloy nanoparticles with complex nanostructures such as shape control, core-shell and dumbells -Oxide nanoparticles and nanostructures, with complex oxide/metal, oxide/surface and oxide /organic interfaces -Inorganic semi-conducting nanoparticles (quantum dots) with an emphasis on new phases, structures, shapes and complexity -Nanostructures involving molecular inorganic species such as nanoparticles of coordination compounds, molecular magnets, spin transition nanoparticles etc. or organic nano-objects, in particular for molecular electronics -Nanostructured materials such as nano-MOFs and nano-zeolites -Hetero-junctions between molecules and nano-objects, between different nano-objects & nanostructures or between nano-objects & nanostructures and surfaces -Methods of characterization specific of the nano size or adapted for the nano size such as X-ray and neutron scattering, light scattering, NMR, Raman, Plasmonics, near field microscopies, various TEM and SEM techniques, magnetic studies, etc .
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