References of "Hubert, Philippe"
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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 detailQuantitative determination of salbutamol sulfate impurities using achiral supercritical fluid chromatography
Dispas, Amandine ULg; Desfontaine, Vincent; Andri, Bertyl ULg et al

in Journal of Pharmaceutical & Biomedical Analysis (2017), 134

In the last years, supercritical fluid chromatography has largely been acknowledged as a singular and performing technique in the field of separation sciences. Recent studies highlighted the interest of ... [more ▼]

In the last years, supercritical fluid chromatography has largely been acknowledged as a singular and performing technique in the field of separation sciences. Recent studies highlighted the interest of SFC for the quality control of pharmaceuticals, especially in the case of the determination of the active pharmaceutical ingredient (API).Nevertheless, quality control requires also the determination of impurities. The objectives of the present work were to i) demonstrate the interest of SFC as a reference technique for the determination of impurities in salbutamol sulfate API and ii) to propose an alternative to a reference HPLC method from the European Pharmacopeia (EP) involving ionpairing reagent. Firstly, a screening was carried out to select the most adequate and selective stationary phase. Secondly, in the context of robust optimization strategy, the method was developed using design space methodology. The separation of salbutamol sulfate and related impurities was achieved in 7 minutes, which is seven times faster than the LC-UV method proposed by European Pharmacopeia (total run time of 50 minutes). Finally, full validation using accuracy profile approach was successfully achieved for the determination of impurities B, D, F and G in salbutamol sulfate raw material. The validated dosing range covered 50 to 150 % of the targeted concentration (corresponding to 0.3 % concentration level), LODs close to 0.5 μg/mL were estimated. The SFC method proposed in this study could be presented as a suitable fast alternative to EP LC method for the quantitative determination of salbutamol impurities. [less ▲]

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See detailContinuous Production of Itraconazole-based Solid Dispersions by Hot Melt Extrusion: Preformulation, Optimization and Design Space Determination.
Thiry, Justine ULg; Lebrun, Pierre; Vinassa, Chloé et al

in International Journal of Pharmaceutics (2016), 515(1-2), 114-124

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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 detailASSURANCE QUALITE et RECHERCHE …
Hubert, Philippe ULg

Scientific conference (2016, December 01)

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See detailMonitoring of anatabine release by methyl jasmonate elicited BY-2 cells using surface-enhanced Raman scattering
De Bleye, Charlotte ULg; Dumont, Elodie ULg; Dispas, Amandine ULg et al

in Talanta (2016), 160

A new application of surface-enhanced Raman scattering (SERS) in the field of plant material analysis is proposed in this study. The aim was to monitor the release of anatabine by methyl jasmonate (MeJa ... [more ▼]

A new application of surface-enhanced Raman scattering (SERS) in the field of plant material analysis is proposed in this study. The aim was to monitor the release of anatabine by methyl jasmonate (MeJa) elicited Bright Yellow-2 (BY-2) cells. Gold nanoparticles (AuNps) were used as SERS substrate. The first step was to study the SERS activity of anatabine in a complex matrix comprising the culture medium and BY-2 cells. The second step was the calibration. This one was successfully performed directly in the culture medium in order to take into account the matrix effect, by spiking the medium with different concentrations of anatabine, leading to solutions ranging from 250 to 5000 µg L-1. A univariate analysis was performed, the intensity of a band situated at 1028 cm-1, related to anatabine, was plotted against the anatabine concentration. A linear relationship was observed with a R2 of 0.9951. During the monitoring study, after the MeJa elicitation, samples were collected from the culture medium containing BY-2 cells at 0, 24h, 48h, 72h and 96h and were analyzed using SERS. Finally, the amount of anatabine released in the culture medium was determined using the response function, reaching a plateau after 72h of 82 µg of anatabine released / g of fresh weight (FW) MeJa elicited BY-2 cells. [less ▲]

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See detailA simple calibration approach based on film-casting for confocal Raman microscopy to support the development of a Hot-Melt Extrusion process
Netchacovitch, Lauranne ULg; Thiry, Justine ULg; De Bleye, Charlotte ULg et al

in Talanta (2016), 154

When developing a new formulation, the development, calibration and validation steps of analytical methods based on vibrational spectroscopy are time-consuming. For each new formulation, real samples must ... [more ▼]

When developing a new formulation, the development, calibration and validation steps of analytical methods based on vibrational spectroscopy are time-consuming. For each new formulation, real samples must be produced and a “reference method” must be used in order to determine the Active Pharmaceutical Ingredient (API) content of each sample. To circumvent this issue, the paper presents a simple approach based on the film-casting technique used as a calibration tool in the framework of hot-melt extrusion process. Confocal Raman microscopic method was successfully validated for the determination of itraconazole content in film-casting samples. Then, hot-melt extrusion was carried out to produce real samples in order to confront the results obtained with confocal Raman microscopy and Ultra High Performance Liquid Chromatography (UHPLC). The agreement between both methods was demonstrated using a comparison study based on the Bland and Altman’s plot. [less ▲]

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