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一种用于量化药物混合物中摩擦起电的单纯形质心设计。

A Simplex Centroid Design to Quantify Triboelectric Charging in Pharmaceutical Mixtures.

机构信息

Department of Pharmaceutical Sciences, University of Connecticut, Storrs, Connecticut 06269.

Department of Statistics, University of Connecticut, Storrs, Connecticut 06269.

出版信息

J Pharm Sci. 2020 May;109(5):1765-1771. doi: 10.1016/j.xphs.2020.02.001. Epub 2020 Feb 24.

Abstract

The present study focuses on the implementation of a modified simplex centroid statistical design to predict the triboelectrification phenomenon in pharmaceutical mixtures. Two drugs (Ibuprofen and Theophylline), 2 excipients (lactose monohydrate and microcrystalline cellulose/MCC), and 2 blender wall materials (aluminum and poly-methyl methacrylate) were studied to identify the trends in charge transfer in pharmaceutical blends. The statistical model confirmed the excipient-drug interactions, irrespective of the blender wall materials, as the most significant factor leading to reduced charging. Also, lactose monohydrate was able to explain the charge variability more consistently compared with MCC powders when used as secondary material. The ratio of the individual components in the blends explained almost 80% of the bulk charging for Ibuprofen mixtures and 70% for Theophylline mixtures. The study also explored the potential lack of efficacy of lactose-MCC as a combination in ternary systems when compared with binary mixtures, for impacts on charge variability in pharmaceutical blends.

摘要

本研究聚焦于改进单纯形质心法统计设计在预测药物混合物摩擦起电现象中的应用。选用两种药物(布洛芬和茶碱)、两种辅料(一水乳糖和微晶纤维素/MCC)和两种混合器壁材料(铝和聚甲基丙烯酸甲酯),以确定药物混合物中电荷转移的趋势。统计模型证实,辅料-药物相互作用是导致充电减少的最主要因素,而与混合器壁材料无关。此外,一水乳糖作为次要材料时,比 MCC 粉末更能更一致地解释电荷变化。混合物中各成分的比例几乎可以解释布洛芬混合物 80%的整体充电和茶碱混合物 70%的整体充电。该研究还探讨了当与二元混合物相比时,乳糖-MCC 作为三元系统组合的潜在疗效缺失,以影响药物混合物中电荷变化。

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