Chemical imaging analysis of active pharmaceutical ingredient in dissolving microneedle arrays by Raman spectroscopy
Chemical imaging analysis of active pharmaceutical ingredient in dissolving microneedle arrays by Raman spectroscopy
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DOI：
10.1007/s13346-021-01052-y
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发表时间：
2021-08-24
影响因子：
5.4
通讯作者：
Izutsu, Ken-ichi
中科院分区：
文献类型：
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作者：
Ando, Daisuke;Miyazaki, Tamaki;Izutsu, Ken-ichi
本研究的目的是建立一种溶解微针阵列（DMNAs）的质量评价方法，并确定药物在DMNAs中的空间分布模式。拉曼光谱映射用于可视化药物分布在DMNA和载药聚合物膜作为模型。还进行了粉末X射线衍射（PXRD）和高压液相色谱法来表征DMNAs。载药聚合物膜和DMNA通过干燥涂布在板上的水溶液或浇铸来制备。PXRD分析表明，双氯芬酸钠（DCF）的结晶在几种形式取决于其在透明质酸钠（HA）为基础的薄膜中的量。HA和DCF的拉曼光谱分别在1376和1579 cm（-1）拉曼位移处显示出特征峰和非重叠峰。载药膜中DCF的特征峰强度在4.8 ~ 16.7%（DCF，w/w）范围内随药物含量的增加而线性增加。拉曼成像分析揭示了小DCF晶体在这些薄膜中的均匀分散。拉曼成像表明DCF在DMNA针表面上的分布。这项工作突出了使用拉曼光谱映射的好处，以揭示药物在DMNAs的空间分布。
The purpose of this study was to develop a quality evaluation method for dissolving microneedle arrays (DMNAs) and determine the spatial distribution pattern of drugs in DMNAs. Raman spectroscopy mapping was used to visualize the drug distribution in DMNAs and drug-loaded polymer films as a model. Powder X-ray diffraction (PXRD) and high-pressure liquid chromatography were also performed to characterize DMNAs. Drug-loaded polymer films and DMNAs were prepared by drying the aqueous solutions spread on the plates or casting. PXRD analysis suggested the crystallization of diclofenac sodium (DCF) in several forms depending on its amount in the sodium hyaluronate (HA)-based films. The Raman spectra of HA and DCF showed characteristic and non-overlapping peaks at 1376 and 1579 cm(-1) Raman shifts, respectively. The intensity of the characteristic peak of DCF in the DCF-loaded films increased linearly with the increasing drug content in the range of 4.8 to 16.7% (DCF, w/w). Raman imaging analysis revealed a homogenous dispersion of small DCF crystals in these films. Raman imaging indicates the distribution of DCF on the surface of the DMNA needle. This work highlights the benefit of using Raman spectroscopy mapping to reveal the spatial distribution of drugs in DMNAs.