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Evaluation of Suspected Counterfeit Pharmaceutical Tablets Declared to Contain Controlled Substances Using Handheld Raman Spectrometers.
J Forensic Sci. 2020 Jul; 65(4):1274-1279.JF

Abstract

This study describes the performance of handheld Raman devices for determining whether suspect pharmaceutical tablets declared to contain controlled substances were consistent with authentic (CWA) or not consistent with authentic (NCWA) tablets using a simple, rapid, field-friendly method capable of being used by nonexperts. Twenty-five authentic products and 84 known NCWA tablets were examined using three "parent" devices for a total of 327 analyses. On average, the parent devices yielded a true pass rate of 100%, a true fail rate of 98.4%, a false pass rate of 1.6%, and a false fail rate of 0%. The methods/libraries were then transferred to 13 identical "daughter" devices, which were used to examine 10 suspect finished dosage forms in duplicate (six known NCWA tablets and four authentic tablets) for a total of 260 measurements. On average, the daughter devices had a true pass rate of 100%, a true fail rate of 95.5%, a false pass rate of 4.5%, and a false fail rate of 0.0%. These data demonstrate that the parent-daughter electronic transfer method was successful, which permits the ability to develop methods in the laboratory that can be seamlessly pushed out to field devices. The methods can then be used to (i) prioritize samples for additional testing using other more time-consuming laboratory-based techniques needed to detect and quantify active ingredients and (ii) help support the interdiction of dangerous tablets at ports of entry, thereby preventing them from reaching the supply chain.

Authors+Show Affiliations

Forensic Chemistry Center, Office of Regulatory Science, Office of Regulatory Affairs, U.S. Food & Drug Administration, Cincinnati, OH, 45237.Forensic Chemistry Center, Office of Regulatory Science, Office of Regulatory Affairs, U.S. Food & Drug Administration, Cincinnati, OH, 45237.Forensic Chemistry Center, Office of Regulatory Science, Office of Regulatory Affairs, U.S. Food & Drug Administration, Cincinnati, OH, 45237.Forensic Chemistry Center, Office of Regulatory Science, Office of Regulatory Affairs, U.S. Food & Drug Administration, Cincinnati, OH, 45237.Forensic Chemistry Center, Office of Regulatory Science, Office of Regulatory Affairs, U.S. Food & Drug Administration, Cincinnati, OH, 45237.Forensic Chemistry Center, Office of Regulatory Science, Office of Regulatory Affairs, U.S. Food & Drug Administration, Cincinnati, OH, 45237.Forensic Chemistry Center, Office of Regulatory Science, Office of Regulatory Affairs, U.S. Food & Drug Administration, Cincinnati, OH, 45237.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31986222

Citation

Lanzarotta, Adam, et al. "Evaluation of Suspected Counterfeit Pharmaceutical Tablets Declared to Contain Controlled Substances Using Handheld Raman Spectrometers." Journal of Forensic Sciences, vol. 65, no. 4, 2020, pp. 1274-1279.
Lanzarotta A, Kimani MM, Thatcher MD, et al. Evaluation of Suspected Counterfeit Pharmaceutical Tablets Declared to Contain Controlled Substances Using Handheld Raman Spectrometers. J Forensic Sci. 2020;65(4):1274-1279.
Lanzarotta, A., Kimani, M. M., Thatcher, M. D., Lynch, J., Fulcher, M., Witkowski, M. R., & Batson, J. S. (2020). Evaluation of Suspected Counterfeit Pharmaceutical Tablets Declared to Contain Controlled Substances Using Handheld Raman Spectrometers. Journal of Forensic Sciences, 65(4), 1274-1279. https://doi.org/10.1111/1556-4029.14287
Lanzarotta A, et al. Evaluation of Suspected Counterfeit Pharmaceutical Tablets Declared to Contain Controlled Substances Using Handheld Raman Spectrometers. J Forensic Sci. 2020;65(4):1274-1279. PubMed PMID: 31986222.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of Suspected Counterfeit Pharmaceutical Tablets Declared to Contain Controlled Substances Using Handheld Raman Spectrometers. AU - Lanzarotta,Adam, AU - Kimani,Martin M, AU - Thatcher,Michael D, AU - Lynch,John, AU - Fulcher,Moseley, AU - Witkowski,Mark R, AU - Batson,JaCinta S, Y1 - 2020/01/27/ PY - 2019/11/15/received PY - 2019/12/31/revised PY - 2020/01/08/accepted PY - 2020/1/28/pubmed PY - 2021/1/26/medline PY - 2020/1/28/entrez KW - TruScan KW - authenticity testing KW - controlled substances KW - counterfeit pharmaceuticals KW - forensic chemistry KW - handheld Raman spectrometers SP - 1274 EP - 1279 JF - Journal of forensic sciences JO - J Forensic Sci VL - 65 IS - 4 N2 - This study describes the performance of handheld Raman devices for determining whether suspect pharmaceutical tablets declared to contain controlled substances were consistent with authentic (CWA) or not consistent with authentic (NCWA) tablets using a simple, rapid, field-friendly method capable of being used by nonexperts. Twenty-five authentic products and 84 known NCWA tablets were examined using three "parent" devices for a total of 327 analyses. On average, the parent devices yielded a true pass rate of 100%, a true fail rate of 98.4%, a false pass rate of 1.6%, and a false fail rate of 0%. The methods/libraries were then transferred to 13 identical "daughter" devices, which were used to examine 10 suspect finished dosage forms in duplicate (six known NCWA tablets and four authentic tablets) for a total of 260 measurements. On average, the daughter devices had a true pass rate of 100%, a true fail rate of 95.5%, a false pass rate of 4.5%, and a false fail rate of 0.0%. These data demonstrate that the parent-daughter electronic transfer method was successful, which permits the ability to develop methods in the laboratory that can be seamlessly pushed out to field devices. The methods can then be used to (i) prioritize samples for additional testing using other more time-consuming laboratory-based techniques needed to detect and quantify active ingredients and (ii) help support the interdiction of dangerous tablets at ports of entry, thereby preventing them from reaching the supply chain. SN - 1556-4029 UR - https://www.unboundmedicine.com/medline/citation/31986222/Evaluation_of_Suspected_Counterfeit_Pharmaceutical_Tablets_Declared_to_Contain_Controlled_Substances_Using_Handheld_Raman_Spectrometers_ L2 - https://doi.org/10.1111/1556-4029.14287 DB - PRIME DP - Unbound Medicine ER -