title: Rapid screening of anti-infective drug products for counterfeits using Raman spectral library-based correlation methods.
abstract: A new spectral library-based approach that is capable of screening a diverse set of finished drug products using only an active pharmaceutical ingredient spectral library is described in this paper. This approach obviates the need for a comprehensive drug product library, thereby streamlining the use of spectral library-based tests for anti-counterfeiting efforts, specifically to target finished drug products containing the wrong active ingredient or no active ingredient at all. Both laboratory-based and portable spectrometers are used in the study to demonstrate the usefulness and transferability of the spectral correlation method for field screening. The spectral correlation between the active pharmaceutical ingredient and finished drug product spectra is calculated using both full spectral analysis and targeted spectral regions analysis of six types of antimalarial, antibiotic and antiviral products. The spectral regions were determined using a moving window spectral correlation algorithm, and the use of specific spectral regions is shown to be crucial in screening finished drug products using only the active pharmaceutical ingredient spectrum. This comprehensive screening spectral correlation method is tested on seven different validation samples from different manufacturers as those used to develop the method, as well as simulated counterfeits which were prepared to mimic falsified drugs containing no active ingredient. The spectral correlation method is successful in correctly identifying 100% of the authentic products and simulated counterfeit samples tested.
authors.affiliation: U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis, St. Louis, MO 63110, USA. Jason.Rodriguez@fda.hhs.gov.
authors.forename: Yvette L
authors.initials: YL
authors.lastname: Loethen
authors.forename: John F
authors.initials: JF
authors.lastname: Kauffman
authors.forename: Lucinda F
authors.initials: LF
authors.lastname: Buhse
authors.forename: Jason D
authors.initials: JD
authors.lastname: Rodriguez
mesh_terms: D000465:Algorithms; D000900:Anti-Bacterial Agents / Q000032:analysis / Q000737:chemistry; D000890:Anti-Infective Agents / Q000032:analysis* / Q000737:chemistry; D000962:Antimalarials / Q000032:analysis / Q000737:chemistry; D000998:Antiviral Agents / Q000032:analysis / Q000737:chemistry; D002626:Chemistry, Pharmaceutical / Q000379:methods; D058110:Counterfeit Drugs / Q000032:analysis* / Q000737:chemistry; D012815:Signal Processing, Computer-Assisted; D013059:Spectrum Analysis, Raman / Q000379:methods*; D013678:Technology, Pharmaceutical / Q000379:methods
chemical_list: D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents; D000962:Antimalarials; D000998:Antiviral Agents; D058110:Counterfeit Drugs