References of "Marini Djang'Eing'A, Roland"
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See detailComparing the qualitative performances of handheld NIR and Raman spectrophotometers for the detection of falsified pharmaceutical products
Ciza, Patient; Sacre, Pierre-Yves ULiege; Waffo Tchounga, Christelle ULiege et al

in Talanta (2019), 202

Over the last decade, the growth of the global pharmaceutical market has led to an overall increase of substandard and falsified drugs especially on the African market (or emerging countries). Recently ... [more ▼]

Over the last decade, the growth of the global pharmaceutical market has led to an overall increase of substandard and falsified drugs especially on the African market (or emerging countries). Recently, several methods using handheld/portable vibrational spectroscopy have been developed for rapid and on-field drug analysis. The objective of this work was evaluate the performances of various NIR and Raman handheld spectrophotometers in specific brand identification of medicines through their primary packaging. Three groups of drug samples (artemether-lumefantrine, paracetamol, and ibuprofen) were used in tablet or capsule forms. In order to perform a critical comparison, the analytical performances of the two analytical systems was compared statistically using three methods: hierarchical clustering algorithm (HCA), data-driven soft independent modeling of class analogy (DD-SIMCA) and hit quality index (HQI). The overall results show good detection abilities for NIR systems compared to Raman systems based on Matthews’s correlation coefficients, generally close to one. Raman systems are less sensitive to the physical state of the samples than the NIR systems, it also suffers of the auto-fluorescence phenomenon and the signal of highly dosed active pharmaceutical ingredient (e.g. paracetamol or lumefantrine) may mask the signal of low-dosed and weaker Raman active compounds (e.g. artemether). Hence, Raman systems are less effective for specific product identification purposes but are interesting in the context of falsification because they allow a visual interpretation of the spectral signature (presence or absence of API). [less ▲]

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See detailComparison of hyperspectral imaging techniques for the elucidation of falsified medicines composition
Coic, Laureen ULiege; Sacre, Pierre-Yves ULiege; Dispas, Amandine ULiege et al

in Talanta (2019), 198

Hyperspectral imaging has shown a high potential to analyze falsifications of solid pharmaceutical products since the last decade. Thanks to the non-destructive, ecological and non-invasive properties, it ... [more ▼]

Hyperspectral imaging has shown a high potential to analyze falsifications of solid pharmaceutical products since the last decade. Thanks to the non-destructive, ecological and non-invasive properties, it is a preferred technique for these kinds of applications. Moreover, thanks to the spectroscopic properties, it is possible to detect as well organic compounds as inorganic compounds in a single analysis. Therefore, we recommend using it as second-line laboratory analysis technique. Raman microscopy and Fourier Transform Infrared (FT-IR) microscopy are two interesting techniques that are complementary. In this study, the potential of the two hyperspectral imaging techniques is evaluated to elucidate the composition of falsified antimalarial tablets. Hyperspectral data are analyzed by Multivariate Curve Resolution-Alternating Least Square (MCR-ALS). The results obtained from this study show that Raman hyperspectral imaging seems to be more suited to detect low dosed compounds possibly due to a smallest sampling volume. It has been also possible to link formulations of falsified samples of two different brands. [less ▲]

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See detailAuthentication of falsified medicine tablets by handheld Raman spectroscopy class modeling
Coic, Laureen ULiege; Sacre, Pierre-Yves ULiege; Avohou, Tonakpon Hermane ULiege et al

Conference (2019, January 01)

Since last decades, the world has known significant changes in the pharmaceutical products sale. The emergence of the internet trade is an important issue because it is easy to sell medicines without ... [more ▼]

Since last decades, the world has known significant changes in the pharmaceutical products sale. The emergence of the internet trade is an important issue because it is easy to sell medicines without passing any control. Moreover, in low- and middle-income countries (LMIC), the number of local pharmacies has grown, increasing the risk to have substandard or falsified medicines. Indeed, according to the World Health Organization (WHO) it is difficult to ensure quality medicines due to areas conflict, corrupted governments and poor health system [1]. For that reason, several analytical techniques have been developed since last decade. One of the most interesting tool is the Minilab, developed by the Global Pharma Health Fund (GPHF), which is a mobile mini-laboratory for fast drug quality control. Moreover, Raman spectroscopy has gained a great interest because it can be used at any step of analytical chain or on the fieldwork with handheld devices. However, spectroscopic data implies development of chemometrics models to gather relevant information. Several unsupervised techniques have already been used to authenticate drug products [2-3]. Due to the intrinsic properties of classification methods, class modeling is more appropriated to this kind of analysis. Indeed, falsified medicines can be quite different from the calibration set, so that, it does not have sense to attribute a class meanwhile it is dissimilar to the calibration set. In this study, the performances of two class-modeling techniques will be evaluated on handheld Raman spectra, to separate falsified medicines from authentic drugs. Three different generics of paracetamol, ibuprofen and artemether-lumefantrine with different dosage, dosage form and formulations were analyzed. Most of them were gathered in local Belgium pharmacies and other were gathered in Africa (artemether-lumefantrine formulations). Samples were analyzed with a handheld Raman spectrophotometer Pharma 21CFR part 11 qualified (Truscan RM, Thermo Scientific, USA) directly through the blister. In order to have a good representativeness of intra-batch variability, 10 tablets were analyzed per sample. The acquisition parameters were set to default. Two models were tested: one-class PLS (OC-PLS) [4] and the data driven-soft independent modeling class analogy (DD-SIMCA) [5]. All the computations were done in Matlab® (R2017b). The calibration and validation set was the same for each model and composed of 60 spectra for each, with different batch number. Because of the nature of each algorithm, there is a significant difference in terms of separation. Looking at Figure 1, the separation of dosage form for ibuprofen is much different between the two models. For the DD-SIMCA, it is more difficult to separate the long acting release from the soft capsule/coated tablet compared to the OC-PLS model. For the other API, similar results are obtained for the dosage and for the brand. It seems that the OC-PLS is more sensitive to the small spectral variabilities. In the case of artemether-lumefantrine formulations, the separation between samples is much more difficult. Indeed, the lumefantrine is a high Raman scatterer. This can explain that the signal of artemether and excipients is difficult to access. Elsewhere, in terms of development, the DD-SIMCA is much harder to optimize because there are more tunable parameters than for OC-PLS. Furthermore, both models are really influenced by spectral pretreatment. An optimization has to be done for each. The authentication of pharmaceutical products by handheld Raman spectroscopy has been possible thanks to class modeling. Both tested algorithms shown interesting results regarding the separation of samples depending on their characteristics. The optimization of data processing and pre-processing is the key-step to improve as sensitivity as specificity of both class modeling methods. [less ▲]

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See detailMission ERASMUS+ A KIGALI
Marini Djang'Eing'A, Roland ULiege

Report (2018)

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See detailFirst inter-laboratory study of a Supercritical Fluid Chromatography method for the determination of pharmaceutical impurities
Dispas, Amandine ULiege; Marini Djang'Eing'A, Roland ULiege; Desfontaine, Vincent et al

in Journal of Pharmaceutical and Biomedical Analysis (2018), 161

Supercritical Fluid Chromatography (SFC) has known a strong regain of interest for the last 10 years, especially in the field of pharmaceutical analysis. Besides the development and validation of the SFC ... [more ▼]

Supercritical Fluid Chromatography (SFC) has known a strong regain of interest for the last 10 years, especially in the field of pharmaceutical analysis. Besides the development and validation of the SFC method in one individual laboratory, it is also important to demonstrate its applicability and transferability to various laboratories around the world. Therefore, an inter-laboratory study was conducted and published for the first time in SFC, to assess method reproducibility, and evaluate whether this chromatographic technique could become a reference method for quality control (QC) laboratories. This study involved 19 participating laboratories from 4 continents and 9 different countries. It included 5 academic groups, 3 demonstration laboratories at analytical instrument companies, 10 pharmaceutical companies and 1 food company. In the initial analysis of the study results, consistencies within- and between-laboratories were deeply examined. In the subsequent analysis, the method reproducibility was estimated taking into account variances in replicates, between-days and between-laboratories. The results obtained were compared with the literature values for liquid chromatography (LC) in the context of impurities determination. Repeatability and reproducibility variances were found to be similar or better than those described for LC methods, and highlighted the adequacy of the SFC method for QC analyses. The results demonstrated the excellent and robust quantitative performance of SFC. Consequently, this complementary technique is recognized on equal merit to other chromatographic techniques. [less ▲]

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See detailTesting for the matrix effect in pharmaceutical samples
Marini Djang'Eing'A, Roland ULiege

Conference (2018, October 25)

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See detailComparing the qualitative performances of handheld NIR and Raman spectrometers for the analysis of falsified pharmaceutical products.
Ciza Hamuli, Patient ULiege; Waffo Tchounga, Christelle ULiege; Coic, Laureen ULiege et al

Poster (2018, September)

The last decade has seen a significant growth of the pharmaceutical market of emerging countries to the point that it has induced many falsifications. Research activities have followed this growth but not ... [more ▼]

The last decade has seen a significant growth of the pharmaceutical market of emerging countries to the point that it has induced many falsifications. Research activities have followed this growth but not proportionately. Recently, several chemical analysis methods for the detection of counterfeit or falsified drugs have been developed using spectroscopic techniques. In this study, different spectrometers were used to collect near-infrared (NIR) and Raman spectral data sets of selected drugs to help improve existing methods. The objective of this work was to evaluate the qualitative performances of the NIR and Raman spectrometers; two benchtop equipment (NIR and Raman) and four handheld ones (three Raman and one NIR) were used. In particular, we made a critical comparison in the evaluation of the accuracy of the prediction. The predictive ability of the different equipments was compared statistically using chemometrics: clustering algorithm, soft modeling (DD-SIMCA) and hard modeling (PLS-DA). All these chemometric strategies were applied on each equipment. Clustering approaches, DD-SIMCA and PLSDA enabled us to compare the qualitative performances of handheld NIR and Raman equipment and to make a critical analysis of their use in the field of the detection of falsified drugs. [less ▲]

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See detailSolving composition of falsified artemether/lumefantrine formulation by hyperspectral imaging
Coic, Laureen ULiege; Sacre, Pierre-Yves ULiege; Avohou, Tonakpon Hermane ULiege et al

Poster (2018, September)

The emerging internet trade and its potential significant profitability cause falsified drugs to be one of the major public health issues of the 21st century. Although some preventing measures - such as ... [more ▼]

The emerging internet trade and its potential significant profitability cause falsified drugs to be one of the major public health issues of the 21st century. Although some preventing measures - such as the new European Parliament Directive 2011/62/UE - have been taken during the last decade, drugs are subject to more frequent monitoring from the authorities. New techniques thus have to be developed in order to help them investigate the relationships between falsified drugs and industries. Some preliminary tests such as visual inspection or colorimetric testing can be performed in order to check drug authenticity. When these tests are inconclusive, spectroscopy and hyperspectral imaging can be used to provide more information, especially to characterize the composition of presumed falsified samples. The efficiency of this technique has no longer to be proven. Vibrational hyperspectral imaging has many advantages such as the non-destruction of the sample and the possibility to combine spectral and spatial information. Once obtained, the hyperspectral data may be decomposed in its various spectral (qualitative) and spatial (quantitative) components using resolution algorithms such as MCR-ALS. The resolution of the spectral component allows the elucidation of the complete formulation composition without a priori knowledge, including mineral and organic compounds. This composition may be used as a production fingerprint for further forensic investigations. In this study, six artemether/lumefantrine formulations (two batches of Combiart 20/120 and four batches of Coartem 20/120) have been analyzed for falsification suspicion. First, a handheld Raman spectroscopic analysis has been performed confirming the falsification. The analysis confirmed the supposed absence of active compounds. In order to complete the knowledge of the formulations, one tablet per sample has been further analyzed by hyperspectral imaging. The MCR-ALS decomposition of the hyperspectral data cube shows that five out of the six samples (2 Combiart and 3 Coartem) have the same composition. Those samples are composed by two active compounds: sildenafil and ciprofloxacine chlorhydrate monohydrate at traces level by same excipients (organic and inorganic). This finding seems to indicate that despite different brand names, packaging and tablet shapes, these samples come from the same production. [less ▲]

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See detailForensic formulation fingerprinting of falsified medicine by Raman hyperspectral imaging
Sacre, Pierre-Yves ULiege; Coic, Laureen ULiege; Avohou, Tonakpon Hermane ULiege et al

Conference (2018, September)

With the Medicrime convention (in 2010) and the European Parliament directive 2011/62/UE (in 2011), the notion of pharmaceutical crime appeared allowing effective, proportionate, and deterring sanctions ... [more ▼]

With the Medicrime convention (in 2010) and the European Parliament directive 2011/62/UE (in 2011), the notion of pharmaceutical crime appeared allowing effective, proportionate, and deterring sanctions against the falsifiers. However, to be able to apply these sanctions, the authorities must collect information allowing them to go up to the manufacturing sites. This is however extremely complex at a global scale. The opportunity to link several falsification cases is one more brick laid in building the investigation. Hyperspectral imaging is not a new analytical tool and has been used in many research papers some of them about falsified medicines. However, the time has come to re-evaluate its place in the suspect formulation workflow. From our point of view, after a formulation is confirmed falsified (or substandard) by a first line investigation (e.g. visual inspection, handheld Raman or colorimetric testing), hyperspectral imaging should always be performed when possible (solid pharmaceutical forms). Indeed, in a single imaging analysis, one may access qualitative, semi-quantitative and distributional homogeneity of organic and inorganic constituents of the formulation. These inform on the risk of taking the medicine but most of all it provides a unique fingerprint of the production allowing the linking of falsification cases. To illustrate this, six artémether/luméfantrine formulations (two batches of Combiart 20/120 and four batches of Coartem 20/120) have been analyzed for falsification suspicion. Handheld Raman spectroscopic analysis rapidly confirmed the falsification and possibly the absence of active compound. Once confirmed falsified, one tablet of each formulation underwent Raman hyperspectral imaging on the whole sample surface. A chemometric analysis of the spectral data revealed the presence of traces of two active compounds (sildenafil and ciprofloxacine chlorhydrate monohydrate) and the same excipients (organic and inorganic) in five formulations (2 Combiart and 3 Coartem) allowing us to link these cases. [less ▲]

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See detailBayesian securing of the pharmaceutical supply chain
Sacre, Pierre-Yves ULiege; Avohou, Tonakpon Hermane ULiege; Lebrun, Pierre ULiege et al

Conference (2018, September)

Introduced in 2011, the European Union Falsified Medicines Directive asks for an enhanced security of the pharmaceutical supply chain. In this frame, manufacturers must apply safety measures to enable the ... [more ▼]

Introduced in 2011, the European Union Falsified Medicines Directive asks for an enhanced security of the pharmaceutical supply chain. In this frame, manufacturers must apply safety measures to enable the verification of authenticity and identification of individual packs. This is the so-called serialization of the pharmaceutical supply chain. However, these measures are only dedicated to the analysis of the secondary packaging and do not enable the analysis of the product’s quality. Therefore, we propose an end-to-end strategy based on spectroscopic fingerprints and risk-oriented statistical models for the verification of the quality of medicines along the supply chain. They can provide a precise description of the chemical composition of samples, and hence can be used to fingerprint a pharmaceutical product. A representative set of these spectra is sampled from each batch at release using appropriate devices. This sample is used to build a statistical tolerance band, that is assumed to contain a high proportion, say at least 90% of the future spectra of the product. The construction of such a band relies on the newly emerging chemometrics techniques such as functional data analysis (e.g. Bayesian wavelet or splines regressions). The upper and lower limits of the tolerance band are used as threshold or reference spectra for the conformity of a new spectrum. This allows us to declare the conformity of a product with a certain probability confidence. Compared to classical measures (p-values, Hit Quality Indexes), this functional data analysis and risk-oriented approach enables to detect very small perturbations of the spectrum caused, for example by degradation, batch inversion, etc. The computed tolerance band may be stored in a cloud server and accessed throughout the supply chain to check the conformity of the product itself. The spectral serialization of pharmaceutical batches is another brick in the wall of pharmaceutical supply chain securing. [less ▲]

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See detailInvestigation of the Quality of Antibiotics-Based Amoxicillin for Monitoring of Some Different Medicine Markets of Democratic Republic of Congo
Kalenda Tshilombo, Nicodème ULiege; Ciza Hamuli, Patient ULiege; Mbinze Kindenge, Jérémie ULiege et al

in American Journal of Analytical Chemistry (2018), 9

In order to combat the counterfeiting of drugs, adapted HPLC analytical USP methods were applied to evaluate the quality of the amoxicillin (with or without potassium clavulanate) powder for suspension ... [more ▼]

In order to combat the counterfeiting of drugs, adapted HPLC analytical USP methods were applied to evaluate the quality of the amoxicillin (with or without potassium clavulanate) powder for suspension sold in some Congolese markets. The adaptation has been done by modifying the column dimensions and adjusting the flow rate. According to the intended deployment of these methods in Demo-cratic Republic of Congo (DRC), 3 factors (analyst, day and equipment) were in-volved in the validation step while applying the classic total error measurement approach with an accuracy profile as decision tool. Since adequate results were obtained in terms of selectivity, precision, trueness and accuracy (tolerance limits of life expectancy: -6.0% and 3.8%) for levels of interest concentration, the methods have been considered for routine use on several samples from different provenances and collected in 4 major DRC cities. Out of 278 samples collected, 200 were eligible for analysis from which 28% were found under standards with several figures: pH failure, out of specification for amoxicillin content, absence of potassium clavulanate, physical modifications of the powders. As evidenced by these findings, medicines of low-quality continue to be a major public health problem requiring appropriate action to effectively address this problem. [less ▲]

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See detailDeterminants of Self-medication of Children by Their Parents at Kisangani
Mande Bukaka; Tebandite Kasali, Emmanuel; Marini Djang'Eing'A, Roland ULiege et al

in Asian Journal of Research in Medical and Pharmaceutical Sciences (2018), 4(1),

Aims: To describe features of self-medication of children and determine factors associated with it. Study Design: This was a cross-sectional study. Place and Duration of Study: This study was conducted in ... [more ▼]

Aims: To describe features of self-medication of children and determine factors associated with it. Study Design: This was a cross-sectional study. Place and Duration of Study: This study was conducted in five hospitals of Kisangani, in the Democratic Republic of Congo. Methodology: We included all parents who brought their children for a new consultation. The dependent variables were the fact of giving medicines to children and the reasons related to this practice. Collected data were managed by Epi info™ 7.2.0.1. Chi-square test and Odds ratio evaluated the association between the level of instruction and other variables at 95% confidence interval. Results: During the study period, 403 parents answered to our questionnaire. Most of them were mothers (94.8%). Parents’ education level was low (62.53%). Most of sick children were between 2 to 24 months-old (54.6%). They received at home 2.1 ± 1.3 drugs (1 to 8 drugs; median: 2 drugs): 81% were modern, 14% combined modern and traditional and 5% were traditional alone. Tablets and syrups were the two most used forms. Antipyretics like paracetamol were the most used. Parents gave drugs with dosage errors in 58% of cases. Only 37.8% of them asked advice from a physician, nurse or pharmacist to determine the dose. The main reasons for giving medicines without prescription were avoidance of too many formalities in hospitals or lack of enough money to bring children to the hospital. Factors associated with self-medication were the female sex of parents (P = .004), the longer duration of the disease before bringing the child to the hospital (OR 1.5: 0.9 – 2.5; P = .04) and storage at home of drugs used formerly (OR 1.8: 1.1 – 3.1; P = .01). Parents of 30 years-old and less gave fewer medicines than more above 30 years-old (P = .0005). Conclusion: The rate of children self-medication is high at Kisangani. Communication of health professionals, doctors, nurses and pharmacists is needed to reduce it. [less ▲]

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See detailCLASSIFICATION OF FLUCONAZOLE API POLYMORPHIC FORMS IN PHARMACEUTICAL PRODUCTS BY ASSOCIATING FTIR, NIR AND RAMAN TO PLS-DA
Alaoui Mansouri, Mohammed ULiege; Sacre, Pierre-Yves ULiege; Ziemons, Eric ULiege et al

Poster (2018, June 26)

The main goal of this work was to prove the ability of the combination between vibrational spectroscopy techniques and PLS-DA to differentiate between different polymorphic forms of fluconazole in ... [more ▼]

The main goal of this work was to prove the ability of the combination between vibrational spectroscopy techniques and PLS-DA to differentiate between different polymorphic forms of fluconazole in pharmaceutical products. These are mostly manufactured based on fluconazole polymorphic form- II and form- III. These crystalline forms may undergo polymorphic transition during the manufacturing or storage conditions process. Therefore, it is important to confirm if the expected polymorphic form is still present or not. FT-IR, FT-NIR and Raman spectroscopies were associated to PLS-DA and used to build robust classification models to distinguish between form- II, Form- III and monohydrate form. Based on the results, it is shown that PLS-DA models have a high efficiency to classify various fluconazole polymorphs, with a high sensitivity and specificity. Finally, the selectivity of the PLS-DA models is proven based on the analysis of two samples of itraconazole and miconazole that belong to the same antifungal class as fluconazole. These two samples mimic potential contaminants. Based on the plots of Hotelling T² vs Q residuals, miconazole and itraconazole are significantly considered outliers and rejected. [less ▲]

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See detailMission ERASMUS+ A KINSHASA ET KISANGANI
Marini Djang'Eing'A, Roland ULiege

Report (2018)

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See detailAntihyperglycemic Activity of Vernonia amygdalina Leaf Extracts, Hibiscus esculentus Fruit Extract and Garcinia kola Seed Extract from Kisangani Plants
Katemo Muhoya, Frédéric; Marini Djang'Eing'A, Roland ULiege; Kadima Ntokamunda, Justin Léonard

in Journal of Pharmaceutical Research International (2018), 21(5),

Objective: Many plants used in traditional medicine still need to be studied scientifically in order to verify their medical usefulness and standardize their pharmaceutical properties. The present study ... [more ▼]

Objective: Many plants used in traditional medicine still need to be studied scientifically in order to verify their medical usefulness and standardize their pharmaceutical properties. The present study aimed at evaluating the antihyperglycemic activity of aqueous and alcoholic extracts from local species of Vernonia amygdalina Delile (Va), Hibiscus esculentus (He) and Garcinia kola Heckel (Gk). Methods: The tests were done on Va-aqueous, Va-ethanolic, Va-butanolic and Va-saponin leaf extracts; He-aqueous fruit extract and Gk-aqueous seed extract. The extracts were prepared using conventional methods. The activity was evaluated in male rabbits given orally 100 mg of extracts per Kg BW and overloaded with glucose (4 g/Kg) 30 minutes later. Glibenclamide 0.2 mg/Kg was given as reference positive control. A negative control group of untreated animals was also included. Blood samples were collected on the animal ear at different times. The assay was performed using a handheld Glucometer®. Results: The percentages of reduction in glycemia calculated on the basis of the negative control values were 60.5% for glibenclamide, 70.5% for Va-ethanol, 57.6% for Va-aqueous, 42.2% for Va-butanol, 54.5% for He-aqueous and 58.7% for Gk-aqueous. Va-saponins fraction was inactive; it increased the baseline glycemia instead of reducing. Conclusion: All extracts have a relative reduction activity comparable to glibenclamide with the exception of Va-saponins. Improved tradimedicines can be prepared with ethanolic or polyphenolic dry extracts. [less ▲]

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