Comparison of genuine, generic and counterfeit Cialis tablets using vibrational spectroscopy and statistical methods
Identifikátory výsledku
Kód výsledku v IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F60461373%3A22330%2F21%3A43922198" target="_blank" >RIV/60461373:22330/21:43922198 - isvavai.cz</a>
Nalezeny alternativní kódy
RIV/60461373:22340/21:43922198 RIV/60461373:22810/21:43922198
Výsledek na webu
<a href="https://reader.elsevier.com/reader/sd/pii/S0731708521004945?token=E81AC19227DD3BA8699C72FBC7821B9587DF3EC64C36FB1A237E2EDF00D4FD73A2BA7C705FBCAF2A172A20CF37F4DD50&originRegion=eu-west-1&originCreation=20211227142057" target="_blank" >https://reader.elsevier.com/reader/sd/pii/S0731708521004945?token=E81AC19227DD3BA8699C72FBC7821B9587DF3EC64C36FB1A237E2EDF00D4FD73A2BA7C705FBCAF2A172A20CF37F4DD50&originRegion=eu-west-1&originCreation=20211227142057</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.jpba.2021.114383" target="_blank" >10.1016/j.jpba.2021.114383</a>
Alternativní jazyky
Jazyk výsledku
angličtina
Název v původním jazyce
Comparison of genuine, generic and counterfeit Cialis tablets using vibrational spectroscopy and statistical methods
Popis výsledku v původním jazyce
The dubious online market in phosphodiesterase type 5 inhibitors is growing on a global scale. Counterfeit medical products can represent health issues for the user and cause medical mistrust. Within this work, genuine Cialis containing the active pharmaceutical ingredient (API) tadalafil, its generics available in the Czech Republic and the Cialis tablets from questionable online pharmacies were analysed. The methods of infra-red and Raman spectroscopy were used for the identification of the counterfeit tablets and for the verification of their API and excipients. All 9 tablets from online pharmacies were counterfeit with 2 of them even containing a different API (sildenafil, vardenafil). In addition, Raman mapping was used to determine the API and excipients’ distribution and, in combination with multivariate data analysis, to separate similar tablets in clusters and to identify the outliers. Scanning electron microscopy of the samples revealed that the process of a wet granulation of micronized API was used during the formulation of the tablets. This comprehensive approach of analysis can be used for advanced exploration of the dubious samples of various medical products. © 2021 Elsevier B.V.
Název v anglickém jazyce
Comparison of genuine, generic and counterfeit Cialis tablets using vibrational spectroscopy and statistical methods
Popis výsledku anglicky
The dubious online market in phosphodiesterase type 5 inhibitors is growing on a global scale. Counterfeit medical products can represent health issues for the user and cause medical mistrust. Within this work, genuine Cialis containing the active pharmaceutical ingredient (API) tadalafil, its generics available in the Czech Republic and the Cialis tablets from questionable online pharmacies were analysed. The methods of infra-red and Raman spectroscopy were used for the identification of the counterfeit tablets and for the verification of their API and excipients. All 9 tablets from online pharmacies were counterfeit with 2 of them even containing a different API (sildenafil, vardenafil). In addition, Raman mapping was used to determine the API and excipients’ distribution and, in combination with multivariate data analysis, to separate similar tablets in clusters and to identify the outliers. Scanning electron microscopy of the samples revealed that the process of a wet granulation of micronized API was used during the formulation of the tablets. This comprehensive approach of analysis can be used for advanced exploration of the dubious samples of various medical products. © 2021 Elsevier B.V.
Klasifikace
Druh
J<sub>imp</sub> - Článek v periodiku v databázi Web of Science
CEP obor
—
OECD FORD obor
10406 - Analytical chemistry
Návaznosti výsledku
Projekt
<a href="/cs/project/VJ01010043" target="_blank" >VJ01010043: Pharmacrime – forenzní identifikace prohormonů a padělků léčiv</a><br>
Návaznosti
P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)
Ostatní
Rok uplatnění
2021
Kód důvěrnosti údajů
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Údaje specifické pro druh výsledku
Název periodika
Journal of Pharmaceutical and Biomedical Analysis
ISSN
0731-7085
e-ISSN
—
Svazek periodika
206
Číslo periodika v rámci svazku
30 November 2021
Stát vydavatele periodika
GB - Spojené království Velké Británie a Severního Irska
Počet stran výsledku
7
Strana od-do
114383
Kód UT WoS článku
000706843600001
EID výsledku v databázi Scopus
2-s2.0-85115802683