Chromatography

Drug eluting stents (DES) have become a standard of care for the treatment of symptomatic atherosclerotic coronary artery disease. DES combine drug and device components, and are therefore combination products within the meaning of section 503(g) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 353(g). Analytical methods used in drug eluting stents analysis must be suffi ciently accurate, specifi c, sensitive and precise to ensure quality and reliability of the results, which in turn are crucial for ensuring the quality, stability, safety and effi ciency of DES. Th ere are numerous challenges to overcome when developing analytical methods for the DES products. Th e low levels of the active substance(s) loaded on the DES and their poor water solubility, low levels of other analytes of interest (residual solvent, monomer content, lactic acid, oligomers, and antioxidants) and the presence of polymer(s) in the sample matrix make the selection of sample pretreatment, detection mode and the development of separation conditions extremely diffi cult. Limited guidance is available on how to achieve an appropriate consideration of the analytical variability in analytical methods used to monitor the quality of the DES products over the shelf-life and set the appropriate method validation acceptance criteria to maintain the method capability and demonstrate its suitability for the intended purpose.

 

Publications

1. Kamberi M and Rapoza R (2016) Stability testing of drug-eluting stents (DES). J. Drug Deliver Sci. Technol. 35:58–68.

2. Kamberi M and Tran T N (2012) UV-visible spectroscopy as an alternative to liquid chromatography for determination of everolimus in surfactant-containing dissolution media: A useful approach based on solid-phase extraction. J Pharm Biomed Anal 70:94–100.

3. Kamberi M (2009) A novel accelerated in-vitro release assay for biodegradable coating of everolimus drug eluting stent: Insight to the drug release mechanisms. Eur J Pharm Sci. 37:217–22.

4. Kamberi M, Fu K, Lu J, Chemali M and Feder D (2007) A high-throughput, highly sensitive, HPLC assay for the simultaneous determination of everolimus and clobetasol. J Chromatogr Sci 46:23–29.

5. Kamberia M, Garcia H, Federa D P and Rapoza R J (2011) Setting acceptance criteria for validation of analytical methods of drug eluting stents: Minimum requirements for analytical variability. Eur. J Pharm Sci. 42:230–37.