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Applications of vibrational spectroscopy and imaging for the analysis of substandard or falsified medicines.
Sacre, Pierre-Yves; Waffo Tchounga, Christelle Ange; Ciza Hamuli, Patient et al.
2022
 

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Keywords :
falsified; substandard; vibrational spectroscopy; handheld; Raman spectroscopy; NIR spectroscopy
Abstract :
[en] Access to quality medicines is an essential right of the patients. However, in 2017, the World Health Organization estimated that 1 in 10 medical products circulating in low- and middle-income countries is either substandard or falsified. This reinforces the fact that post-marketing surveillance (PMS) of medical products by strong national regulatory authorities (NRA) is crucial. To achieve an efficient PMS, the NRA need analytical tools at the inspection, screening, confirmatory and forensics levels to control the physicochemical properties of the samples. Because of their fast, non-destructive, and relatively affordable character, vibrational spectroscopy tools are unavoidably present at each step. Handheld devices are particularly useful during inspection and screening phases since these tools can identify and/or quantify active pharmaceutical ingredients (API) even through opaque packaging in seconds. However, they generally need exhaustive and up-to-date databases for each specific product. Another limitation is the work and time needed before going into the field to develop and validate the chemometric models. Indeed, this mandatory step requires highly skilled scientists and a prior collection of certified references of the medicines to analyse. Benchtop systems and among them imaging systems are particularly useful in the confirmatory and forensic steps. Indeed, the imaging systems enable the visualization and identification of a large range of both organic and inorganic compounds used as API or excipients. In addition, thanks to the high spatial resolution, it allows the detection of trace contaminants. This information may be of particular interest during prosecutions and the clustering of criminal cases. Nevertheless, the extraction of the relevant information from the raw measurements requires once again intensive work by highly trained staff. In conclusion, vibrational spectroscopy tools have particularly interesting features for the PMS of medicines, but research is still needed to make them easier to set up and use by NRA inspectors and non-specialists.
Research Center/Unit :
CIRM - Centre Interdisciplinaire de Recherche sur le Médicament - ULiège
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Sacre, Pierre-Yves  ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Waffo Tchounga, Christelle Ange  ;  Université de Liège - ULiège > CIRM
Ciza Hamuli, Patient  ;  Université de Liège - ULiège > CIRM
Avohou, Tonakpon Hermane ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
De Bleye, Charlotte  ;  Université de Liège - ULiège > Département de pharmacie > Département de pharmacie
Hubert, Philippe  ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Marini Djang'Eing'A, Roland ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Ziemons, Eric  ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Language :
English
Title :
Applications of vibrational spectroscopy and imaging for the analysis of substandard or falsified medicines.
Publication date :
02 February 2022
Event name :
CIRM DAY
Event organizer :
CIRM
Event date :
02 fevrier 2022
Available on ORBi :
since 03 February 2022

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