Biomedical Research Centre, Sheffield Hallam University, Howard Street, Sheffield S1 1WB, UK.
Rapid Commun Mass Spectrom. 2010 Jun 15;24(11):1665-72. doi: 10.1002/rcm.4525.
Matrix-Assisted Laser Desorption/Ionisation Mass Spectrometry Imaging (MALDI MSI) has been used to directly analyse a range of tablets in order to assess the homogeneity of the active drug compound throughout the excipients contained within the tablets studied. The information gained from the imaging experiments can be used to improve and gain a greater understanding of the manufacturing process; such knowledge will enable improvements in finished product quality to make safer and more efficacious tablet formulations. Commercially available and prescription tablet formulations have been analysed, including aspirin, paracetamol, sildenafil citrate (Viagra(R)) and a batch of tablets in development (tablet X: placebo; 1 mg; 3 mg and 6 mg). MALDI MSI provides semi-quantitative information that is related to ion abundance, therefore Principal Component Analysis (PCA), a multivariate analysis technique, has been used to differentiate between tablets containing different amounts of active drug ingredient. Aspects of sample preparation have also been investigated with regard to tablet shape and texture. The results obtained indicate that MALDI MSI can be used effectively to analyse the spatial distribution of the active pharmaceutical component (API) in pharmaceutical tablet formulations.
基质辅助激光解吸/电离质谱成像（MALDI MSI）已被用于直接分析多种片剂，以评估研究片剂中所含辅料中活性药物化合物的均一性。从成像实验中获得的信息可用于改进和更好地理解制造工艺；这种知识将使成品质量得到改进，从而生产出更安全、更有效的片剂配方。已分析了市售和处方片剂制剂，包括阿司匹林、对乙酰氨基酚、西地那非 citrate（伟哥（R））和一批正在开发的片剂（片剂 X：安慰剂；1mg；3mg 和 6mg）。MALDI MSI 提供与离子丰度相关的半定量信息，因此已使用主成分分析（PCA），一种多元分析技术，来区分含有不同量活性药物成分的片剂。还研究了与片剂形状和纹理有关的样品制备方面。所得结果表明，MALDI MSI 可有效地用于分析药物片剂制剂中活性药物成分（API）的空间分布。
