ANYL 463 |
| Drug-eluting stents are composed of an active pharmaceutical ingredient within a polymer matrix. As part of the chemical characterization of the formulation, an understanding of the spatial distribution of components is required. Confocal Raman microscopy is a powerful tool to nondestructively characterize drug-polymer stent coatings. We generated a set of formulation standards to predict the concentration of drug and polymers found in the CYPHER® Sirolimus-eluting Coronary Stent. Quantitative spatial models were generated by partial least squares (PLS) analysis after spectral image preprocessing was performed. The challenges to the PLS methods included the low signal-to-noise ratio per pixel and spectral interferences (cosmic rays and fluorescence). The quantitative models were tested on independent sample sets to gage the accuracy and precision of the predictions. The implications of quantitative spatial information on understanding bulk performance properties will be discussed.
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Analytical Approaches
1:30 PM-4:30 PM, Thursday, August 23, 2007 BCEC -- 104A, Oral
Division of Analytical Chemistry |