References of "Marini Djang'Eing'A, Roland"
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See detailEtude comparative des profils de dissolution in vitro de quinine sulfate générique et princeps en utilisant la Chromatographie Liquide Haute Performance
Mbinze Kindenge, Jérémie ULg; Diallo, Tediane; Yemoa, Loconon ULg et al

in Médecine d'Afrique Noire (2017), 64

Introduction : La quinine est une molécule préconisée pour le traitement du paludisme dans les régions où les souches de P. falciparum sont polyrésistantes. Face à l’importante utilisation de ses ... [more ▼]

Introduction : La quinine est une molécule préconisée pour le traitement du paludisme dans les régions où les souches de P. falciparum sont polyrésistantes. Face à l’importante utilisation de ses médicaments génériques d’une part, et au fléau des médicaments de qualité inférieure d’autre part, il devient plus que nécessaire d’appuyer les données des tests physico-chimiques par celles de dissolution in vitro dont l’évaluation et la comparaison des cinétiques permettra de prédire le comportement in vivo du principe actif et par conséquent l’efficacité du médicament générique. L’objectif de la présente étude est de réaliser une étude comparative de la cinétique de dissolution d’un princeps et d’un générique à base de quinine comprimé 300 mg commercialisés à Kinshasa. Matériels et méthodes : L’étude a été réalisée en utilisant trois milieux de pH différents (1,2 - 4,5 - 6,8) tels que recommandés par l’Agence Européenne de Médicament et en se servant d’un appareil de dissolution, tandis que l’équipement de chromatographie liquide à haute performance couplée à un détecteur à barrette de diodes a été utilisé pour la quantification. La méthode statistique fit factor a été appliquée pour comparer les résultats de dosage de la quinine dans les trois milieux tout en ayant évalué le biais à différents temps de dissolution. Résultats : Les différents échantillons de médicaments générique et princeps ont été conformes quant à l’identification et au dosage de la quinine, par contre leurs cinétiques de dissolution étaient non similaires. Discussion : Ceci pourrait avoir une influence sur l’efficacité du produit générique et la sécurité des consommateurs, dénotant l’importance d’examiner les profils de dissolution des génériques avant toute autorisation de mise sur le marché plus particulièrement dans les pays en voie de développement. [less ▲]

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See detailLe fléau des faux médicaments
Marini Djang'Eing'A, Roland ULg; Ziemons, Eric ULg; Sacre, Pierre-Yves ULg et al

Conference given outside the academic context (2017)

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See detailINVESTIGATION DE LA QUALITE D’ANTIBIOTIQUES A BASE D'AMOXICILLINE DANS LE CADRE DE LA SURVEILLANCE DU MARCHE OFFICIEL ET PERIPHERIQUE DE QUELQUES VILLES DE LA R.D. CONGO
Kalenda Tshilombo, Nicodème ULg; Ciza Hamuli, Patient ULg; Mavungu Landu, Don Jethro ULg et al

Poster (2017, March)

Drug counterfeiting is a sad and worrisome reality, especially in developing countries where quality control is not effective and sometimes not existing at all despite political will of governments. The ... [more ▼]

Drug counterfeiting is a sad and worrisome reality, especially in developing countries where quality control is not effective and sometimes not existing at all despite political will of governments. The consequences are harmful in particular for substandard medicines that pose more threats to populations in those countries due to their direct negative impact on patients such as failure of medical treatment including development of drug resistance and even death. Socio-economic consequences and negative reputation concerning the pharmaceutical industry are also observed. Unfortunately accurate detailed data on such medicines are not easy to obtain. Most of the time available data are often estimated from case reports or studies carried out in a specific area and during a defined period.Health authorities’ in the Democratic Republic of Congo are trying to identify this scourge by set up several strategies to fight against. One of them is built on the best knowledge of drugs from several horizons through the assessment of their quality to allow appropriate measurement. In this context, we have focused our study towards amoxicillin alone and/or combined with potassium clavulanate since it is one the very used medicines in pediatric medications. The formulations are powder for suspension. Two analytical methods were developed based on the USP monography, applying isocratic liquid chromatography. Prior to their application in routine, we evaluated the suitability of these methods through validation applying the accuracy profile of total error. Since it was planned to transfer the methods to DRC, several operating factors were taken into account namely operator, day and equipment. Interesting results were obtained in terms of trueness (relative biases below than 2.3%), precision (RSD of Intermediate precision below 2.8%), accuracy (beta-expectation tolerance intervals between -6.0% and 3.8%) for the concentration levels of interest. The latter were able to allow monitoring the quality of the two active ingredients here above in the 65 samples from Congolese market. They were collected in Kinshasa, Lubumbashi, Matadi and Kolwezi at official and non-official medicines distributors, in peripheral area. The dramatic results obtained confirm that substandard and counterfeit medicines remain a crucial problem on public health in low-income countries. Appropriate measures are really needed to set up the drug quality improvement. [less ▲]

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See detailUV Visible Spectrophotometric Determination of the Quality of Antiretroviral Drugs Distributed in Kinshasa
Ntambwe Kamangu, Erick; Mbinze Kindenge, Jérémie ULg; Mingu M., Arnold et al

in Open Acces Library Journal (2017)

Background: Antiretrovirals (ARVs) are the molecules used in the fight against infection by the Human Immunodeficiency Virus (HIV). Their main objective is to stop the virus from replicating and thus ... [more ▼]

Background: Antiretrovirals (ARVs) are the molecules used in the fight against infection by the Human Immunodeficiency Virus (HIV). Their main objective is to stop the virus from replicating and thus allow the immune system to recover. In 2001, the program to fight against HIV/AIDS United Nations (UNAIDS) and its partners has decided to strengthen the pharmaceutical channel and improve access to good quality care. Thus ARV quality control is recommended. Objective: The objective of this work was to monitor the quality of ARVs distributed in Kinshasa. Methodology: In this work, UV-visible spectrophotometry is used for the analysis of ARVs presented in simple form distributed in the city of Kinshasa. Results: The results of this work show that the stated and analyzed ARVs contain active ingredients; there is no placebo. Ten percent of these ARVs are non-compliant with regard to dosing of the active test. Conclusion: These results confirm the need to control these drugs to protect patients from adverse consequences related to their poor quality. [less ▲]

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See detailApplication of design space optimization strategy to the developmentof LC methods for simultaneous analysis of 18 antiretroviral medicinesand 4 major excipients used in various pharmaceutical formulations
Habyalimana, Védaste ULg; Mbinze Kindenge, Jérémie ULg; Yemoa, Loconon ULg et al

in Journal of Pharmaceutical & Biomedical Analysis (2017), 139

tAs one of the world’s most significant public health challenges in low- and middle-income countries,HIV/AIDS deserves to be treated with appropriate medicines, however which are not spared from coun ... [more ▼]

tAs one of the world’s most significant public health challenges in low- and middle-income countries,HIV/AIDS deserves to be treated with appropriate medicines, however which are not spared from coun-terfeiting. For that, we developed screening and specific HPLC methods that can analyze 18 antiretroviralmedicines (ARV) and 4 major excipients. Design of experiments and design space methodology wereinitially applied for 15 ARV and the 4 excipients with prediction thanks to Monte Carlo simulations andfocusing on rapidity and affordability thus using short column and low cost organic solvent (methanol)in gradient mode with 10 mM buffer solutions of ammonium hydrogen carbonate. Two other specificmethods dedicated to ARV in liquid and in solid dosage formulations were also predicted and opti-mized. We checked the ability of one method for the analysis of a fixed-dose combination composedby emtricitabine/tenofovir/efavirenz in tablet formulations. Satisfying validation results were obtainedby applying the total error approach taking into account the accuracy profile as decision tool. Then, thevalidated method was applied to test two samples coded A and B, and claimed to contain the tested ARV.Assay results were satisfying only for sample B. [less ▲]

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See detailCombination of Partial Least Squares regression and Design of Experiments to model the retention of pharmaceuticals in Supercritical Fluid Chromatography
Andri, Bertyl ULg; Dispas, Amandine ULg; Marini Djang'Eing'A, Roland ULg et al

in Journal of Chromatography. A (2017)

This work presents a first attempt to establish a model of the retention behaviour for pharmaceutical compounds in gradient mode SFC. For this purpose, multivariate statistics were applied on the basis of ... [more ▼]

This work presents a first attempt to establish a model of the retention behaviour for pharmaceutical compounds in gradient mode SFC. For this purpose, multivariate statistics were applied on the basis of data gathered with the Design of Experiment (DoE) methodology. It permitted to build optimally the experiments needed, and served as a basis for providing relevant physicochemical interpretation of the effects observed. Data gathered over a broad experimental domain enabled the establishment of well-fit linear models of the retention of the individual compounds in presence of methanol as co-solvent. These models also allowed the appreciation of the impact of each experimental parameter and their factorial combinations. This approach was carried out with two organic modifiers (i.e. methanol and ethanol) and provided comparable results. Therefore, it demonstrates the feasibility to model retention in gradient mode SFC for individual compounds as a function of the experimental conditions. This approach also permitted to highlight the predominant effect of some parameters (e.g. gradient slope and pressure) on the retention of compounds. Because building of individual models of retention was possible, the next step considered the estab- lishment of a global model of the retention to predict the behaviour of given compounds on the basis of, on the one side, the physicochemical descriptors of the compounds (e.g. Linear Solvation Energy Relationship (LSER) descriptors) and, on the other side, of the experimental conditions. This global model was established by means of partial least squares regression for the selected compounds, in an experimental domain defined by the Design of Experiment (DoE) methodology. Assessment of the model’s predic- tive capabilities revealed satisfactory agreement between predicted and actual retention (i.e. R2 = 0.942, slope = 1.004) of the assessed compounds, which is unprecedented in the field. [less ▲]

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See detailOptimization and validation of a fast Supercritical Fluid Chromatography method for the quantitative determination of vitamin D3 and its related impurities.
Andri, Bertyl ULg; Lebrun, Pierre ULg; Dispas, Amandine ULg et al

in Journal of Chromatography. A (2017)

In the uprising context of green analytical chemistry, Supercritical Fluid Chromatography (SFC) is often suggested as an alternative to Normal Phase Liquid Chromatography. Indeed, SFC provides fast ... [more ▼]

In the uprising context of green analytical chemistry, Supercritical Fluid Chromatography (SFC) is often suggested as an alternative to Normal Phase Liquid Chromatography. Indeed, SFC provides fast, efficient and green separations. In this report, the quantitative performances of SFC were challenged on a real-life case study: the Quality Control (QC) of vitamin D3. A rapid and green SFC method was optimized thanks to the Design of Experiments–Design Space (DoE–DS) methodology. It provided robust and high quality separation of the compounds within a 2 min timeframe, using a gradient of ethanol as co-solvent of the carbon dioxide. The analytical method was fully validated according to the total error approach, demon- strating the compliance of the method to the specifications of U.S. Pharmacopeia (USP: 97.0–103.0%) and European Pharmacopeia (EP: 97.0–102.0%) for an interval of [50–150%] of the target concentration. In order to allow quantification of impurities using vitamin D3 as an external standard in SFC-UV, correction factors were determined and verified during method validation. Thus, accurate quantification of impu- rities was demonstrated at the specified levels (0.1 and 1.0% of the main compound) for a 70.0–130.0% dosing range. This work demonstrates the validity of an SFC method for the QC of vitamin D3 raw material and its application to real samples. Therefore, it supports the switch to a greener and faster separative technique as an alternative to NPLC in the pharmaceutical industry. [less ▲]

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See detailQualité des médicaments antipaludéens et caractéristiques des pharmacies des territoires périurbains de Kinshasa
Mavungu Landu, Don Jethro ULg; Liégeois, Sophie; Manzambi Kuwekita, Joseph ULg et al

Poster (2016, December 14)

Contexte: Le paludisme causé par le Plasmodium falciparum demeure un problème majeur de santé publique. Le traitement avec des antipaludiques de bonne qualité est une composante importante dans le ... [more ▼]

Contexte: Le paludisme causé par le Plasmodium falciparum demeure un problème majeur de santé publique. Le traitement avec des antipaludiques de bonne qualité est une composante importante dans le contrôle de cette maladie. Cependant en Afrique centrale, plus de 25% des médicaments serait contrefaits ou de qualité inférieure, situation qui serait encore plus dramatique dans les territoires périurbains. Méthode: Dans le contexte ci-mentionné, une étude préliminaire et prospective a été menée dans la zone de santé de Mont Ngafula 1 située dans les territoires périurbains de la Ville de Kinshasa durant la période allant du 22 février au 17 mars 2016. Treize échantillons de poudre pour suspension d’artéméther et de luméfantrine ont été collectés. L’analyse de la qualité de ces médicaments a été réalisée au moyen de méthodes séparatives génériques utilisant la technique de chromatographie liquide à haute performance couplé à un détecteur à barrettes de diodes. Une caractérisation a été également effectuée dans 127 établissements pharmaceutiques sur base des normes édictées par le Ministère de la Santé Publique congolais. Résultats: Les résultats des analyses des échantillons d’antimalariques (ou antipaludéens) montre que presque la moitié des poudres pour suspension d’artéméther et de luméfantrine ne contenait pas la concentration prévue en artéméther et/ou en luméfantrine. Par ailleurs, le résultat des observations évoque qu’aucun établissement pharmaceutique ne respecte l’ensemble des normes du Ministère de la Santé Publique. [less ▲]

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See detailL’Assurance Qualité dans un laboratoire
Marini Djang'Eing'A, Roland ULg; Widart, Joëlle ULg; Hubert, Philippe ULg

Learning material (2016)

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See detailQuality Control Laboratories involved in the WHO Prequalification
Marini Djang'Eing'A, Roland ULg

Conference (2016, October)

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See detailFingerprinting and validation of a LC-DAD method for the analysis of biflavanones in Garcinia kola-based antimalarial improved traditional medicines
Tshisekedi Tshibangu, Pascal ULg; Mutwale Kapepula, Paulin ULg; Kabongo Kapinga, Marie Josée et al

in Journal of Pharmaceutical & Biomedical Analysis (2016), 128(2016), 382-390

African populations use traditional medicines in their initial attempt to treat a range of diseases. Nevertheless, accurate knowledge of the composition of these drugs remains a challenge in terms of ... [more ▼]

African populations use traditional medicines in their initial attempt to treat a range of diseases. Nevertheless, accurate knowledge of the composition of these drugs remains a challenge in terms of ensuring the health of population and in order to advance towards improved traditional medicines (ITMs). In this paper chromatographic methods were developed for qualitative and quantitative analyses of a per os antimalarial ITM containing Garcinia kola. The identified analytical markers were used to establish TLC and HPLC fingerprints. G. kola seeds were analysed by HPLC to confirm the identity of the extract used by the Congolese manufacturer in the ITM. The main compounds (GB1, GB2, GB-1a and Kolaflavanone) were isolated by preparative TLC and identified by UPLC–MS and NMR. For the quantification of the major compound GB1, a simple and rapid experimental design was applied to develop an LC method, and then its validation was demonstrated using the total error strategy with the accuracy profile as a decision tool. The accurate results were observed within 0.14–0.45 mg/mL range of GB1 expressed as naringenin. The extracts used in several batches of the analysed oral solutions contained GB1 (expressed as naringenin) within 2.04–2.43%. Both the fingerprints and the validated LC-DAD were found suitable for the quality control of G. kolabased raw material and finished products, respectively. [less ▲]

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See detailMédicaments usage de faux
Sacre, Pierre-Yves ULg; Ziemons, Eric ULg; Hubert, Philippe ULg et al

Article for general public (2016)

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