A method and system for the non-destructive analysis of medical devices
uses a confocal Raman microscope and other non-destructive analytical
tools to assess the spatial distribution of components of an object such
as the distribution of an active pharmaceutical ingredient (API) within a
polymer matrix. In a preferred embodiment, confocal Raman spectroscopy
was used to differentiate each component found in the sirolimus-eluting
coronary stent. The unique spectral features identified for each
component were then used to develop three separate calibration curves to
describe the solid phase distribution found on drug-polymer coated
stents. The calibration curves were obtained by analyzing confocal Raman
spectral depth profiles from a set of 16 unique formulations of
drug-polymer coatings sprayed onto stents and planar substrates.