Direct and real-time quantification of tenofovir release from ph-sensitive microparticles into simulated biological fluids using (1)h nuclear magnetic resonance.
Direct and real-time quantification of tenofovir release from ph-sensitive microparticles into simulated biological fluids using (1)h nuclear magnetic resonance.
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DOI：
10.1002/jps.23886
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发表时间：
2014-04
影响因子：
3.8
通讯作者：
Youan, Bi-Botti C.
中科院分区：
文献类型：
--
作者：
Zhang, Chi;Zhang, Tao;Oyler, Nathan A.;Youan, Bi-Botti C.
关键词：
体外药物释放评价是纳米或微米药物递送系统质量控制的非常重要的一步。然而，大多数定量技术（例如HPLC）需要透析膜将释放的游离药物与这些递送系统分离，因此不能直接检测和实时定量药物释放。本研究首次描述了一种快速、特异性和直接的方法，使用瓦里安 400 MHZ 1H 核磁共振 (1H-NMR) 波谱仪实时定量 pH 敏感微粒体外替诺福韦 (TNF) 的释放。根据国际协调会议 (ICH) 指南，验证了各种分析性能参数，例如线性、精密度、准确度、定量限 (LOQ)、检测限 (LOD) 和稳健性。使用 1 H-NMR 实时监测和定量模拟阴道液 (VFS) 以及 VFS 和模拟精液 (SFS) 的混合物 (VSFS) 中微粒的 TNF 体外释放。体外实时定量微粒药物释放的能力不仅可以更准确地预测其体内生物学行为，而且不受透析膜潜在干扰的影响。
In vitro drug release evaluation is a very important step toward the quality control of nano- or micro-particular drug delivery systems. However, most quantitative techniques such as HPLC requires a dialysis membrane to separate the released free drug from these delivery systems, thus are not capable of direct detection and real-time quantification of the drug release. This study describes for the first time, a rapid, specific, and direct method for the real-time quantification of in vitro tenofovir (TNF) release from pH-sensitive microparticles using a Varian 400 MHZ 1H nuclear magnetic resonance (1H-NMR) spectrometer. Various analytical performance parameters such as linearity, precision, accuracy, limit of quantification (LOQ), limit of detection (LOD), and robustness were validated according to International Conference on Harmonization (ICH) guidelines. The in vitro release of TNF from microparticles in both simulated vaginal fluid (VFS) and the mixture (VSFS) of VFS and simulated semen fluid (SFS) was monitored and quantified in real-time using 1H-NMR. The capability of real-time quantification of in vitro drug release from microparticles not only provides a more accurate prediction of its biological behavior in vivo, but is also independent of potential interference from the dialysis membrane.
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影响因子：
3.4
作者：
FRIEDMAN, D;BENITA, S
通讯作者：
BENITA, S
DOI：
10.1016/s1570-0232(03)00333-7
发表时间：
2003-08-15
影响因子：
3
作者：
Sentenac, S;Fernandez, C;Aymard, G
通讯作者：
Aymard, G
影响因子：
3.8
作者：
Calvo, P;VilaJato, JL;Alonso, MJ
通讯作者：
Alonso, MJ
影响因子：
3.4
作者：
Abdel-Mottaleb, Mona M. A.;Lamprecht, Alf
通讯作者：
Lamprecht, Alf
影响因子：
5.8
作者：
WASHINGTON, C
通讯作者：
WASHINGTON, C