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通过实验设计与白色分析化学相结合对米拉贝隆负载纳米载体进行生态友好且灵敏的微波辅助荧光分光光度表征

An Eco-Friendly and Sensitive Microwave-Aided Spectrofluorophotometric Characterization of Mirabegron-Loaded Nanocarriers by Amalgamation of Design of Experiments and White Analytical Chemistry.

作者信息

Prajapati Pintu, Patel Krishna, Shah Pranav, Surana Vilas, Haque Anzarul, Kalam Mohd Abul, Shah Shailesh

机构信息

Department of Quality Assurance and Pharmaceutics, Maliba Pharmacy College, Surat, Gujarat, India.

Central Laboratories Unit, Qatar University, Doha, Qatar.

出版信息

Luminescence. 2024 Dec;39(12):e70046. doi: 10.1002/bio.70046.

DOI:10.1002/bio.70046
PMID:39662880
Abstract

Mirabegron, a drug for treatment of overactive bladder, has low water solubility and bioavailability. Researchers used quality by design to develop and characterize second-generation lipid nanocarriers for mirabegron, aiming to provide spatially and temporally sustained drug release. Numerous analytical methodologies for assessing mirabegron in pharmaceutical and biological fluids use chemical solvents in the mobile phase, potentially impacting aquatic ecosystems and the environment. The issue was addressed with a microwave-assisted spectrofluorimetric technique, environmentally benign solvents, and a fluorescent probe known as 4-chloro-7-nitrobenzofuran. Researchers used screening design and response-surface methodology to minimize organic waste. The suggested technique satisfied ICH Q2 (R2) and M10 validation standards. This approach described the in vivo pharmacokinetics and in vitro drug release of mirabegron-loaded lipid nano-carriers. We anticipated the chemical reaction pathways that derivatized mirabegron with 4-chloro-7-nitrobenzofuran by the analysis of mass spectra. We assessed the proposed method's environmental effect and sustainability compared to current methods using the RGB model, an analytical greenness calculator, and green analytical process index software. The proposed mirabegron estimate method was user-friendly for analysts, cost-effective, sensitive, robust, and environmentally sustainable, adhering to sustainable analytical practices and reducing ecological consequences.

摘要

米拉贝隆是一种用于治疗膀胱过度活动症的药物,其水溶性和生物利用度较低。研究人员采用质量源于设计的方法来开发和表征米拉贝隆的第二代脂质纳米载体,旨在实现药物的时空缓释。众多用于评估药物和生物流体中米拉贝隆的分析方法在流动相中使用化学溶剂,这可能会对水生生态系统和环境产生影响。研究人员采用微波辅助荧光光谱技术、环境友好型溶剂以及一种名为4-氯-7-硝基苯并呋喃的荧光探针解决了这一问题。研究人员使用筛选设计和响应面方法来尽量减少有机废物。所建议的技术符合国际人用药品注册技术协调会Q2(R2)和M10验证标准。该方法描述了载有米拉贝隆的脂质纳米载体的体内药代动力学和体外药物释放情况。通过质谱分析,我们预测了米拉贝隆与4-氯-7-硝基苯并呋喃衍生化的化学反应途径。我们使用RGB模型、分析绿色度计算器和绿色分析过程指数软件,与现有方法相比,评估了所建议方法的环境影响和可持续性。所建议的米拉贝隆估算方法对分析人员来说操作简便、成本效益高、灵敏、稳健且环境可持续,符合可持续分析实践并减少了生态影响。

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