Three-dimensional compositional analysis of drug eluting stent coatings using cluster secondary ion mass spectrometry.

Cluster secondary ion mass spectrometry (cluster SIMS) employing an SF5+ polyatomic primary ion sputter source in conjunction with a Bi3+ analysis source was used to obtain three-dimensional molecular information in polymeric-based drug-eluting stent coatings. The formulations of the coatings varied from 0% to 50% (w/w) sirolimus drug in poly(lactic-co-glycolic acid) and were prepared on both MP35N metal alloy coupons and bare metal stents. All cluster SIMS depth profiles obtained indicated a drug-enriched surface region, followed by a drug-depletion region, and finally a constant bulk composition region, similar to previous data obtained in polymeric blend systems. The drug overlayer thickness was determined to increase with increasing sirolimus content. Sample temperature was determined to play an important role in the resulting depth profiles, where it was shown that the best profiles were obtained at low temperatures (-100 degrees C). At these temperatures, molecular signals typically remained constant through the entire depth of the film (approximately 6.5 microm) in some cases, as opposed to the typical 1 microm-2 microm depth limit, which is achievable at room temperature. The 3-D imaging capabilities of cluster SIMS were successfully demonstrated and indicated a significant amount of subsurface domain formation in the 25% and 50% sirolimus samples, but not in the 5% sample, which was homogeneous. These results clearly illustrate the utility of cluster SIMS for probing the 3-D structure in polymeric-based drug delivery devices.