Three‐dimensional imaging of pharmaceutical tablets using serial sectioning and Raman chemical mapping

Abstract Chemical mapping by Raman spectroscopy is widely used in the pharmaceutical industry to characterise distribution of components within tablets; however, current methods do not go beyond examining an exposed surface area a sample. There are known limitations with estimating domain size and shape statistics from 2D chemical images as values obtained will depend on where sectioned, potentially under‐ or overestimating its true value. The combination spectroscopic serial sectioning has been recently explored alternative method obtain depth profile sample; date, this involved instrumentation capable automated subsequent sample sectioning. A key requirement for producing optically flat surface, becomes increasingly challenging larger areas required examination tablet. Here, we describe 3D imaging tablet matrix combining independent provide appropriate lateral axial resolution. approach was first validated analysing spherical object comparing calculated reconstructed image absolute values. then applied three‐component model system, simulating tablet, determine capability applicability solid dosage formulations. study demonstrated that relative differences size, domains can be quantified enabling enhanced understanding spatial arrangement each component formulation effect processing condition final drug product. By visualising structure demonstrable accuracy precision using materials dimensions, new capabilities enhance manufacturing now available.