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See detailDevelopment, validation and comparison of NIR and Raman methods for the identification and assay of poor-quality oral quinine drops.
Mbinze Kidenge, Jérémie; Sacre, Pierre-Yves ULg; Yemoa, Achille et al

in Journal of Pharmaceutical & Biomedical Analysis (2015), 111

Poor quality antimalarial drugs are one of the public’s major health problems in Africa. The depth of this problem may be explained in part by the lack of effective enforcement and the lack of efficient ... [more ▼]

Poor quality antimalarial drugs are one of the public’s major health problems in Africa. The depth of this problem may be explained in part by the lack of effective enforcement and the lack of efficient local drug analysis laboratories. To tackle part of this issue, two spectroscopic methods with the ability to detect and to quantify quinine dihydrochloride in children’s oral drops formulations were developed and validated. Raman and Near Infrared (NIR) spectroscopy were selected for the drug analysis due to their low cost, non-destructive and rapid characteristics. Both of the methods developed were successfully validated using the total error approach in the range of 50-150% of the target concentration (20% W/V) within the 10% acceptance limits. Samples collected on the Congolese pharmaceutical market were analyzed by both techniques to detect potentially substandard drugs. After a comparison of the analytical performance of both methods, it has been decided to implement the method based on NIR spectroscopy to perform the routine analysis of quinine oral drop samples in the Quality Control Laboratory of Drugs at the University of Kinshasa (DRC). [less ▲]

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See detailMédicaments: Faux et usage de faux
Sacre, Pierre-Yves ULg; Marini Djang'Eing'A, Roland ULg; Ziemons, Eric ULg et al

Article for general public (2015)

La contrefaçon des médicaments est en constante progression, voire en pleine explosion. Chaque année, elle tue des centaines de milliers de personnes, principalement en Afrique. Véritable fléau, elle est ... [more ▼]

La contrefaçon des médicaments est en constante progression, voire en pleine explosion. Chaque année, elle tue des centaines de milliers de personnes, principalement en Afrique. Véritable fléau, elle est de plus en plus souvent aux mains de réseaux transnationaux d'une profonde opacité. [less ▲]

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See detailFalsification des médicaments: Est-il possible d'améliorer la puissance des outils de détection ?
Ziemons, Eric ULg; Sacre, Pierre-Yves ULg; Marini Djang'Eing'A, Roland ULg et al

Conference given outside the academic context (2015)

La mise sur le marché de médicaments falsifiés est une réalité dont on imagine rarement l’importance et la nuisance : on estime pourtant que ce marché rapporte plus que le trafic de drogue et il arrive ... [more ▼]

La mise sur le marché de médicaments falsifiés est une réalité dont on imagine rarement l’importance et la nuisance : on estime pourtant que ce marché rapporte plus que le trafic de drogue et il arrive que localement, des produits falsifiés soient plus nombreux que les produits originaux (cas des anti-malariques au Congo). La lutte contre la falsification s’est d’abord focalisée sur les emballages et les identificateurs tels que les codes-barres, qui aujourd’hui ne garantissent plus le contenu du médicament vu les progrès réalisés par les organisations criminelles en matière de reproduction d’emballage. La solution sûre consiste donc à analyser, sur place, la composition du produit à travers l’emballage et à comparer le résultat à la «carte d’identité» du médicament établie par le producteur. Les besoins portent donc sur des instruments d’analyse portables et capables de dialoguer à distance avec des banques de données de «cartes d’identité». Ceux-ci requièrent une approche pluridisciplinaire impliquant notamment des micro-électroniciens et des informaticiens. [less ▲]

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See detailFighting Poor Quality Medicines: Develop-ment, Transfer and Validation of Generic HPLC Methods for Analyzing two WHO Recommended Antimalarial Tablets
Mbinze Kindenge, Jérémie; Yemoa, Achille; Lebrun, Pierre ULg et al

in American Journal of Analytical Chemistry (2015), 6

As serious but neglected public health problems, poor quality medicines, i.e. for antimalarial medicines, urged to be fought. One of the approaches is to consider the analytical chemistry and separative ... [more ▼]

As serious but neglected public health problems, poor quality medicines, i.e. for antimalarial medicines, urged to be fought. One of the approaches is to consider the analytical chemistry and separative techniques. In this study, a generic liquid chromatographic method was firstly devel-oped for the purpose of screening 8 antimalarial active ingredients, namely amodiaquine (AQ), piperaquine (PPQ), sulfalene (SL), pyrimethamine (PM), lumefantrine (LF), artesunate (AS), artemether (AM) and dihydroartemisinine (DHA) by applying DoE/DS optimization strategy. Since the method was not totally satisfying in terms of peak separation, further experiments were undergone applying the same development strategy while splitting the 8 ingredients into five groups. Excellent prediction was observed prior to correlation between retention times of predicted and observed separation conditions. Then, a successful geometric transfer was realized to reduce the analysis time focusing on the simultaneous quantification of two WHO's recommended ACTs in anti-malarial fixed-dose combination (AM-LF and AS-AQ) in tablets. The optimal separation was achieved using an isocratic elution of methanol-ammonium formate buffer (pH 2.8; 10mM) (82.5: 17.5, v/v) at 0.6ml/min through a C18 column (100mm×3.5mm, 3.5 μm) thermostated at 25°C. After a successful validation stage based on the total error approach, the method was applied to determine the content of AM/LF or AS/AQ in seven brands of antimalarial tablets currently marketed in West, Central and East Africa. Satisfying results were obtained compared to the claimed contents. [less ▲]

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See detailThorough characterization of a Self-Emulsifying Drug Delivery System with Raman hyperspectral imaging: A case study.
Sacre, Pierre-Yves ULg; Netchacovitch, Lauranne ULg; De Bleye, Charlotte ULg et al

in International Journal of Pharmaceutics (2015), 484

Newly developed drugs often have poor bioavailability due to their poor water solubility (BCS class 2 drugs). It is therefore necessary to develop new strategies to enhance their solubility and their ... [more ▼]

Newly developed drugs often have poor bioavailability due to their poor water solubility (BCS class 2 drugs). It is therefore necessary to develop new strategies to enhance their solubility and their activity, among which, Self-Emulsifying Drug Delivery System (SEDDS). The efficacy of the drugs contained in these preparations is mainly affected by the solid state and the particle size of the active pharmaceutical ingredient (API). However, it is quite complex, long and expensive to characterize these parameters with classical techniques such as X-Ray powder diffraction, differential scanning calorimetry or hot stage microscopy. The present article presents, through a case study, the advantages of the Raman hyperspectral imaging in the characterization of such formulations. Indeed, Raman chemical imaging may fully characterize SEDDS with single equipment and operator in a non-destructive way allowing the follow-up of the formulation during stability studies. Raman imaging is therefore a tool of choice in the PAT framework since it increases the knowledge of the formulation and the process. A quantitative multivariate method using Raman hyperspectral imaging to assay the API in the lipid based formulation has been developed and fully validated following the “total error” approach. [less ▲]

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See detailIntérêt de la spectroscopie vibrationnelle dans le cadre du PAT
Ziemons, Eric ULg; Chavez, Pierre-François ULg; Netchacovitch, Lauranne ULg et al

Scientific conference (2014, November 13)

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See detailRaman hyperspectral imaging: a single tool to characterise pharmaceutical products
Netchacovitch, Lauranne ULg; De Bleye, Charlotte ULg; Chavez, Pierre-François ULg et al

in European Pharmaceutical Review (2014), 19(5), 8-11

Raman hyperspectral imaging is an increasingly used tool in the pharmaceutical field because it allows for the investigation of many characteristics on a solid sample. This paper delves into Raman ... [more ▼]

Raman hyperspectral imaging is an increasingly used tool in the pharmaceutical field because it allows for the investigation of many characteristics on a solid sample. This paper delves into Raman spectroscopy and imaging, including spectral and spatial information, and presents some applications of Raman hyperspectral imaging in the pharmaceutical field. [less ▲]

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See detailData processing of vibrational chemical imaging for pharmaceutical applications.
Sacre, Pierre-Yves ULg; De Bleye, Charlotte ULg; Chavez, Pierre-François ULg et al

in Journal of Pharmaceutical & Biomedical Analysis (2014), 101

Vibrational spectroscopy (MIR, NIR and Raman) based hyperspectral imaging is one of the most powerful tools analyze pharmaceutical preparation. Indeed, it combines the advantages of vibrational ... [more ▼]

Vibrational spectroscopy (MIR, NIR and Raman) based hyperspectral imaging is one of the most powerful tools analyze pharmaceutical preparation. Indeed, it combines the advantages of vibrational spectroscopy to imaging techniques and allows therefore the visualization of distribution of compounds, crystallization processes. However, these techniques provide a huge amount of data that must be processed to extract the relevant information. This review presents fundamental concepts of hyperspectral imaging, the basic theory of the most used chemometric tools used to pre-process, process and post-process the generated data. The last part of the present paper focuses on pharmaceutical applications of hyperspectral imaging and highlights the data processing approaches to enable the reader making the best choice among the different tools available. [less ▲]

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See detailDevelopment of a multiplexed surface-enhanced Raman scattering quantitative approach for bisphenols detection
De Bleye, Charlotte ULg; Dumont, Elodie ULg; Sacre, Pierre-Yves ULg et al

Conference (2014, June 23)

Over the last decade, bisphenol A (BPA) attracted a lot of attention. This molecule, commonly used as a precursor to produce epoxy-resin and plastics, is an endocrine disruptor presenting an estrogenic ... [more ▼]

Over the last decade, bisphenol A (BPA) attracted a lot of attention. This molecule, commonly used as a precursor to produce epoxy-resin and plastics, is an endocrine disruptor presenting an estrogenic activity [1]. Despite its health toxicity, BPA is present in a broad variety of consumer goods released from plastic bottles and packaging for example. Since the discovery of its adverse health effect of BPA, the manufacturers tend to use structural analogues of BPA such as BPS, BPF and BPB to produce plastic materials [2]. However, the health safety of these molecules is still not demonstrated. Currently, bisphenols are actively researched and quantified using solid phase extraction and chromatography techniques which are time and solvents consuming. Therefore, it could be very interesting to quantify simultaneously bisphenols using a fast and “green” technique. Surface-enhanced Raman scattering (SERS) exalts dramatically the Raman scattering of molecules adsorbed or very closed to metallic surface enabling to detect very low amounts of analytes while keeping the structural information obtained from the spectrum which is very interesting to consider multiplexed analyses [3-4]. Moreover, SERS, which is a solvent free and fast acquisition technique, is an attractive tool in “Green Chemistry” [5]. In this context, the development of a multiplexed quantitative approach to detect bisphenol was considered. Silver nanoparticles (AgNps) were selected as SERS substrate and their functionalization was investigated taking into account the weak affinity of phenolic molecules for gold and silver surface [6]. Pyridine was selected as surface modifier and allowed to attract bisphenols around metallic surface thanks to hydrophobic interaction and hydrogen bonds [7]. Afterwards, the SERS samples preparation was optimized playing on the concentrations of pyridine and aggregating agent used to get the nanoparticles closer to each other which promotes the SERS effect. Tap water samples were spiked with different concentration of BPA from 5 ppb to 1000 ppb and analyzed using the optimized SERS sample preparation. A good linearity of the response was observed and a calibration curve with coefficient of determination (R2) of 0.9922 was obtained by plotting the intensity of a principal band of BPA versus the concentration. This last step was repeated using BPB as analyte and a calibration curve with a R2 of 0.9991 was obtained for the same range of concentration using a specific band intensity of BPB. Finally, tap water samples were spiked with different concentrations of BPA and BPB simultaneously and analyzed using SERS and it was possible to detect selectively the two molecules thanks to specific bands and a good linearity of the response was observed for both. To conclude, promising results were obtained which pave the way to “green” multiplexed quantitative analyses of very low concentrated analytes using SERS. References: [1] J.-H. Kang et al., Toxicology 226 (2006) 79-89 [2] C. Liao et al., J. Agric. Food Chem. 61 (2013) 4655-4662 [3] K. Kneipp et al., Chem. Rev. 99 (1999) 2957-2975. [4] R.F. Aroca et al., Adv.Colloid Interface Sci. 116 (2005) 45-61. [5] C. De Bleye et al., Talanta 116 (2013) 899-905. [6] X.X. Han et al., Anal. Chem., 83 (2011) 8582-8588. [7] B. San Vicente et al., Anal. Bioanal. Chem. 380 (2004) 115-122. [less ▲]

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