Confocal Raman microscopy (CRM) mapping is a powerful tool for distribution analysis of components within complex matrices. CRM combines the submicron spatial resolution of confocal microscopy with the nondestructive content analysis capabilities of Raman spectroscopy. CRM maps are generated by raster scanning samples with a focused laser beam and collecting a spectrum at each position. The CRM data is then reconstructed to form an image composed of hundreds to thousands of pixels, each containing a full Raman spectrum. CRM images were generated at different locations within transdermal patch samples to characterize drug product and excipient distribution within an adhesive matrix. A set of formulation standards were prepared, analyzed, and used to build a partial least squares (PLS) model. Component distribution analysis was then performed on a set of nominal patches to determine if any change in drug concentration relative to excipient concentration occurred for nominal patches from manufacture through expiry.

Confocal Raman mapping for distribution analysis of components in a transdermal device

248th National Meeting (2014)

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