Increasingly, today's pharmaceutical and medical device products are more complex and require advanced analytical methodologies for proper characterization suitable for the rigorous regulatory environment. Our laboratory focuses on incorporating new analytical instruments and approaches to characterizing these complex products in order to fully understand mechanisms of drug release, impact of formulation and process on final design, and assisting with investigations into deviations from product performance. An example product is the drug-eluting coronary stent, which contains both the active pharmaceutical ingredient dispersed in a polymer carrier as well as a metallic substrate. Our group has developed several innovative methodologies to characterize DES. Examples discussed will include confocal Raman microscopy (CRM) with multivariate data analysis to assess spatial distribution of components, FTIR microscopy for pattern recognition of components from in vivo explants, quartz crystal microbalance (QCM) with dissipation to examine protein adsorption and swelling behavior of polymer films, and atomic force microscopy (AFM) to examine morphological changes in vitro.

Meeting new analytical challenges for convergent product development in the health care industry

243rd National Meeting (2012)

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