Estimation of the possibility of expanding the instrument base for the rapid detection of falsified medicinal products in the Rivne region

Authors

DOI:

https://doi.org/10.15587/2519-4852.2020.209107

Keywords:

infrared spectroscopy, Raman spectroscopy, quality control of drugs

Abstract

The aim of the research was assessment of ways to expand the instrument base of photometric equipment for quality control of medicines, substantiation of prospects for their implementation and application in the activities of the territorial service for medicines and drug control in Rivne region.

Materials and methods. Literature data, scientific publications on the application of photometric methods in drug quality control and own research on drug quality control were used. The methods of system analysis, bibliosemantic, data generalization was used in the work, the method of absorption spectrophotometry in the infrared region is used in the experimental research.

Results. It is analyzed the effectiveness of IR spectroscopy for quality control of drugs and detection of their counterfeits in the framework of improving modern approaches to counteracting and combating the turnover of drugs in Ukraine. The prospect of using portable Raman spectrometers for drug quality control is established, based on their advantages over IR spectrophotometry. It was analyzed a list of drugs containing (azithromycin, erythromycin, ibuprofen, paracetamol, clarithromycin, cefuroxime sodium), including antipyretics and antibiotics that can be used to treat complications of COVID-19, in the field of involvement of the instrument base of the National University of Water Management and Nature Management and Rivne State University for the Humanities of Rivne.

Novelty of the obtained results. For the first time, the paper suggests the involvement of the instrument base of higher education institutions for routine quality control of drugs and detection of their counterfeits by territorial laboratories for quality control of medicines on the example of Rivne region. The necessity of introduction and equipping of territorial bodies of the state quality control of medicines with portable devices of Raman spectrometry for carrying out express, non-destructive quality control of medicines is substantiated.

Conclusions. The method of Raman spectroscopy is relevant for the implementation of the State Service for Medicines and Drug Control. The introduction of this method and equipment will increase the efficiency of inspections, as well as significantly reduce the time of analysis. According to the results of experimental research on the basis of the National University of Water Management of Rivne and Rivne State University for the Humanities, it is expedient and possible to involve the equipment of regional educational institutions and laboratories to detect counterfeits and prevent their use by the health care system

Author Biographies

Serhii Lebed, National University of Pharmacy Pushkinska str., 53, Kharkiv, Ukraine, 61002 State Service for Medicines and Drug Control in the Rivne region 16 Lypnia str., 38, Rivne, Ukraine, 33028

Postgraduate Student

Department of Organization and Economics

Chief

Alla Nemchenko, National University of Pharmacy Pushkinska str., 53, Kharkiv, Ukraine, 61002

Doctor of Pharmaceutical Sciences, Professor, Head on Department

Department of Organization and Economics

Aleksandr Zdoryk, Institute for Advanced Training of Pharmacy Specialists Zakhystnykiv Ukrainy sq., 17, Kharkiv, Ukraine, 61001

Doctor of Pharmaceutical Sciences, Associate Professor

Department of Quality, Standardization and Certification of Medicines

References

  1. Arzamascev, A. P., Pechennikov, V. M., Rodionova, G. M. et. al. (2000). Analiz lekarstvennykh smesei. Moscow: Kompaniia Sputnik, 275.
  2. Pogodina, L. I. (1985). Analiz mnogokomponentnykh lekarstvennykh form. Minsk: Vysshaia shkola, 240.
  3. Baranova, N. V., Feofanova, M. A. (2011). Primenenie metoda infrakrasnoi spektroskopii v analize lekarstvennykh sredstv. Vestnik Tverskogo gosudarstvennogo universiteta. Seriia Khimiia, 12, 49–56.
  4. Aleksandrova, T. V., Kriuchkova, L. K., Budanova, N. A., Grigoreva, I. V. (2016). Aktualnost primeneniia metoda IK-spektrometrii pri opredelenii podlinnosti lekarstvennykh sredstv v usloviiakh ispytatelnoi laboratorii po kontroliu kachestva lekarstvennykh sredstv. Mezhdunarodnii zhurnal prikladnykh i fundamentalnykh issledovanii, 10 (4), 609–613.
  5. Stepanova, E. V., Dorofeev, V. L., Arzamascev, A. P. (2008). Ispolzovanie metoda IK- spektrofotometrii bez vydeleniia deistvuiuschego veschestva dlia identifikacii lekarstvennykh sredstv ranitidina gidrokhlorida. Vestnik VGU. Seriia: Khimiia, Biologiia, Farmaciia, 2, 153–158.
  6. Trineeva, O. V., Rudaia, M. A., Gudkova, A. A., Slivkin, A. I. (2018). Primenenie IK-spektroskopii v analize lekarstvennogo rastitelnogo syria. Vestnik VGU. Seriia: Khimiia, Biologiia, Farmaciia, 4, 187–194.
  7. Ofitsiinyi Sait Derzhavnoi sluzhby Ukrainy z likarskykh zasobiv ta kontroliu za narkotykamy. Available at: https://www.dls.gov.ua/
  8. Korostashova, I. M. (2012). Borotba proty kontrafaktsii likarskykh zasobiv v Ukraini (pytannia normatyvno-pravovoho zabezpechennia: kryminalne zakonodavstvo ta zakonodavstvo z pytan intelektualnoi vlasnosti). Visnyk Akademii mytnoi sluzhby Ukrainy. Seriia: «Pravo», 2 (9), 65–71.
  9. Derzhavna Farmakopeia Ukrainy. Vol. 1. Kharkiv: Derzhavne pidpryiemstvo «Ukrainskyi naukovyi farmakopeinyi tsentr yakosti likarskykh zasobiv», 1128.
  10. Wilson, B. K., Kaur, H., Allan, E. L., Lozama, A., Bell, D. (2017). A New Handheld Device for the Detection of Falsified Medicines: Demonstration on Falsified Artemisinin-Based Therapies from the Field. The American Journal of Tropical Medicine and Hygiene, 96 (5), 1117–1123. doi: http://doi.org/10.4269/ajtmh.16-0904
  11. Arzamascev, A. P., Senov, P. L. (1978). Standartnye obrazcy lekarstvennykh veschestv. Moscow: Medicina, 248.
  12. Zhiliaeva, M. A., Trofimov, A. R., Ramenskaia, G. V. et. al. (1996). Identifikaciia lekarstvennykh sredstv gruppy 1,4-benzodiazepina po elektronnym i kolebatelnym spektram pogloscheniia. Farmaciia, 45 (5), 35–36.
  13. Kozlov, N. E., Sbezhneva, V. G. (1980). Ispolzovanie IK-spektroskopii dlia ocenki kachestva preparatov – proizvodnykh khloretilamina. Farmaciia, 29 (1), 33–34.
  14. Lazarian, D. S. (1980). IK spectroscopia v analyse necotoryh proizvodnyh benzosulfonamida. Farmaciia, 29 (2), 36–38.
  15. Mynka, A. F., Liuta, M. L. (1985). Vykorystannia IK-spektroskopii dlia identifikacii nikotynovoi kysloty ta ii pohidnyh. Farmacevt, 4, 40–43.
  16. Belikov, V. G. (2000). Identifikaciia preparatov v lekarstvennykh formakh metodom proizvodnoi spektrofotometrii. Farmaciia, 49 (1), 23–25.
  17. Lanzarotta, A., Lorenz, L., Batson, J. S., Flurer, C. (2017). Development and implementation of a pass/fail field-friendly method for detecting sildenafil in suspect pharmaceutical tablets using a handheld Raman spectrometer and silver colloids. Journal of Pharmaceutical and Biomedical Analysis, 146, 420–425. doi: http://doi.org/10.1016/j.jpba.2017.09.005
  18. Ma, B., Wang, L. (2015). An application of rapid detection technologies in a national regulatory laboratory setting: Differentiating imported and domestic drug products of oxcarbazepine using handheld Raman, near infrared, and portable FTIR analyzers. American Pharmaceutical Review, 18 (2).
  19. Nesterov, V. V., Titova, A. I., Evtushenko, I. S. (1991). Ispolzovanie UF spektrofotometrii v kontrole kachestva azidoti-midina. Farmaciia, 40 (3), 30–32.
  20. Kashirin, D. M., Sibilev, A. V., Beloborodov, V. L. et. al. (2000). Primeneniie IK-spektroskopii dlia identifikaciii syntertisheskih peptydnyh preparatov timogena, tymodepressina i neogena. Khimiko-farmacevticheskii zhurnal, 34 (11), 48–51.
  21. Volgram, E. N. (1988). Primenenije IES-spectrofotometrii dlia ustanovlenija kordanuma v trupnom materiale. Sudeb.-med. Ekspertiza, 31 (2), 34–35.
  22. Derzhavna Farmakopeia Ukrainy. T. 2. Kharkiv: Derzhavne pidpryiemstvo «Ukrainskyi naukovyi farmakopeinyi tsentr yakosti likarskykh zasobiv», 52–55.
  23. The State Pharmacopoeia of the Russian Federation. Vol. 1–3 (2015). Moscow. Available at: http://femb.ru/feml
  24. Vickers, S., Bernier, M., Zambrzycki, S., Fernandez, F. M., Newton, P. N., Caillet, C. (2018). Field detection devices for screening the quality of medicines: a systematic review. BMJ Global Health, 3 (4), e000725. doi: http://doi.org/10.1136/bmjgh-2018-000725
  25. Frosch, T., Wyrwich, E., Yan, D., Domes, C., Domes, R., Popp, J., Frosch, T. (2019). Counterfeit and Substandard Test of the Antimalarial Tablet Riamet® by Means of Raman Hyperspectral Multicomponent Analysis. Molecules, 24 (18), 3229. doi: http://doi.org/10.3390/molecules24183229
  26. Dégardin, K., Guillemain, A., Roggo, Y. (2017). Comprehensive Study of a Handheld Raman Spectrometer for the Analysis of Counterfeits of Solid-Dosage Form Medicines. Journal of Spectroscopy, 2017, 1–13. doi: http://doi.org/10.1155/2017/3154035
  27. Arzamascev, A. P., Lutceva, T. Iu., Sadchikova, N. P. (2001). Metody analiza i standartizaciji lekarstvennyh sredstv proizvodnyh barbiturovoi kisloty(obzor). Khimiko-farmacevticheskii zhurnal, 35 (8), 47–51.
  28. Lutceva, A. I., Maslov, L. G. (1999). Metody kontrolia i standartizacii lekarstvennykh preparatov, soderzhaschikh vodorastvorimye vitaminy (obzor). Khimiko-farmacevticheskii zhurnal, 33 (9), 30–37.
  29. Lutceva, A. I., Maslov, L. G., Seredenko, V. I. (2001). Metody kontrolia i standartizacii lekarstvennykh preparatov, soderzhaschikh zhirorastvorimye vitaminy. Khimiko-farmacevticheskii zhurnal, 35 (10), 41–46.

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Published

2020-06-30

How to Cite

Lebed, S., Nemchenko, A., & Zdoryk, A. (2020). Estimation of the possibility of expanding the instrument base for the rapid detection of falsified medicinal products in the Rivne region. ScienceRise: Pharmaceutical Science, (3 (25), 39–43. https://doi.org/10.15587/2519-4852.2020.209107

Issue

No. 3 (25) (2020)

Section

Pharmaceutical Science

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Copyright (c) 2020 Serhii Lebed, Alla Nemchenko, Aleksandr Zdoryk

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