References of "Hubert, Philippe"
     in
Bookmark and Share    
Full Text
Peer Reviewed
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 ULiege; Diallo, Tediane; Yemoa, Loconon ULiege 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 ▲]

Detailed reference viewed: 105 (42 ULiège)
Full Text
See detailRaman Hyperspectral Imaging: An essential tool in the pharmaceutical field
Sacre, Pierre-Yves ULiege; De Bleye, Charlotte ULiege; Netchacovitch, Lauranne ULiege et al

Conference given outside the academic context (2017)

Raman hyperspectral imaging results from the powerful combination of spatial (imaging) and spectral (Raman) information. It is increasingly used both in R&D and in the industry because it allows the ... [more ▼]

Raman hyperspectral imaging results from the powerful combination of spatial (imaging) and spectral (Raman) information. It is increasingly used both in R&D and in the industry because it allows the investigation of many characteristics of solid samples. This technique provides an accurate tool for qualitative and quantitative analysis of a pharmaceutical solid formulation. In this webinar, Assoc. Prof. Ziemons will present fundamental concepts of hyperspectral imaging data analysis and key applications in pharmaceutical and biomedical field. [less ▲]

Detailed reference viewed: 40 (3 ULiège)
Full Text
See detailLe fléau des faux médicaments
Marini Djang'Eing'A, Roland ULiege; Ziemons, Eric ULiege; Sacre, Pierre-Yves ULiege et al

Conference given outside the academic context (2017)

Detailed reference viewed: 32 (9 ULiège)
Full Text
Peer Reviewed
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 ULiege; Ciza Hamuli, Patient ULiege; Mavungu Landu, Don Jethro ULiege 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 ▲]

Detailed reference viewed: 85 (13 ULiège)
Full Text
Peer Reviewed
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 ULiege; Mbinze Kindenge, Jérémie ULiege; Yemoa, Loconon ULiege 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 ▲]

Detailed reference viewed: 36 (3 ULiège)
Full Text
Peer Reviewed
See detailQuantitative determination of salbutamol sulfate impurities using achiral supercritical fluid chromatography
Dispas, Amandine ULiege; Desfontaine, Vincent; Andri, Bertyl ULiege 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 ▲]

Detailed reference viewed: 31 (10 ULiège)
Full Text
See detailCréation d’un Centre d’Excellence en Assurance et Contrôle de Qualité des Médicaments et Produits de Santé
Marini Djang'Eing'A, Roland ULiege; Masereel, Bernard ULiege; Verpoorten, Dominique ULiege et al

Report (2017)

Dans la plupart des pays d’Afrique Subsaharienne, la qualité des médicaments est un problème majeur de santé publique (SP). Ce secteur souffre de la circulation et de la vente des médicaments illicites ... [more ▼]

Dans la plupart des pays d’Afrique Subsaharienne, la qualité des médicaments est un problème majeur de santé publique (SP). Ce secteur souffre de la circulation et de la vente des médicaments illicites, altérés, périmés et même falsifiés, et dont, par ailleurs, la qualité est peu voire non contrôlée. A côté des médicaments « classiques », les produis de santé ainsi que les médicaments traditionnels améliorés (MTA) à base de plantes sont aussi concernés par ces pratiques peu scrupuleuses. A ces pratiques s’additionnent le manque d’assurance sur leur innocuité et leur qualité avec, par conséquent, un déficit au niveau de la sécurité sanitaire des consommateurs qui est aggravée par la prescription, l’administration et l’usage irrationnels. Le présent projet vise à contribuer à l'amélioration de la qualité des médicaments en RDC, éléments pratiquement incontournables de nos jours pour l’amélioration de la SP. Plus spécifiquement, le projet compte renforcer les capacités locales mais aussi régionales de l’Afrique Centrale en termes de formation dans le but de répondre aux besoins quant à la disponibilité de médicaments de qualité et surtout à développer un réseau des personnes formées dans le domaine de la qualité. La mise en œuvre se focalise sur la création d’un centre de référence à l’Unikin évoluant à terme vers un centre d’excellence régional avec trois missions, la formation, la recherche et le service. Au niveau de la formation, deux cursus officiels étalés sur deux ans seront organisés en alternance : (1) Diplômes d’Etudes Supérieures Spécialisées (DESS) en Contrôle des médicaments et (2) DESS en Assurance Qualité. Ces DESS correspondent en Communauté Wallonnie-Bruxelles à un Master de spécialisation. Un Diplôme d’Etudes Supérieures en Analyse des médicaments (DEA) sera également organisé et mènera au doctorat. Enfin, des modules seront ouverts à des formations certifiantes. Celles-ci s’adressent au personnel de santé tel que celui du Ministère de la Santé (Direction du Médicament), du secteur Industriel Pharmaceutique (Laboratoires de fabrication et de contrôle, importateurs, distributeurs), des instituts étatiques de contrôle, des pharmaciens, des médecins, et des étudiants des Facultés/Départements de Pharmacie (3ème cycle). Se rapportant au service, le centre s’orientera sur la résolution des problèmes spécifiques confrontés sur terrain par le personnel cité ci-haut comme par exemple l’analyse des médicaments essentiels, des nouveaux médicaments et de nouvelles formulations médicamenteuses. Pour renforcer de manière pérenne ces formations à l’Unikin, une thèse de doctorat sera réalisée en Sciences Pharmaceutiques avec comme tronc principal le Contrôle Qualité et les implications socio-anthropologiques. La sensibilisation au problème de la qualité et de l’usage optimal des médicaments est également envisagée pour les acteurs indirects du secteur pharmaceutique tels que les autorités et les pouvoirs organisateurs locaux étant donné leur forte implication dans la prise des décisions stratégiques dans ce secteur. L’excellence sera visée afin de renforcer la collaboration scientifique existante avec les universités de la RDC (Kisangani) et de la région de l’Afrique centrale et de l’ouest (U-Douala, U-Yaoundé-1, U-Abomey Calavi, U-Ouagadougou) au travers de la dispensation de certains cours par les enseignants de ces universités et l’attribution des bourses d’excellence aux Assistants de ces universités. [less ▲]

Detailed reference viewed: 34 (1 ULiège)
Full Text
Peer Reviewed
See detailDevelopment of an analytical method for crystalline content determination in amorphous solid dispersions produced by Hot-Melt Extrusion using transmission Raman spectroscopy: A feasibility study.
Netchacovitch, Lauranne ULiege; Dumont, Elodie ULiege; Cailletaud, Johan ULiege et al

in International Journal of Pharmaceutics (2017), 530(1-2), 249-255

The development of a quantitative method determining the crystalline percentage in an amorphous solid dispersion is of great interest in the pharmaceutical field. Indeed, the crystalline Active ... [more ▼]

The development of a quantitative method determining the crystalline percentage in an amorphous solid dispersion is of great interest in the pharmaceutical field. Indeed, the crystalline Active Pharmaceutical Ingredient transformation into its amorphous state is increasingly used as it enhances the solubility and bioavailability of Biopharmaceutical Classification System class II drugs. One way to produce amorphous solid dispersions is the Hot-Melt Extrusion (HME) process. This study reported the development and the comparison of the analytical performances of two techniques, based on backscattering and transmission Raman spectroscopy, determining the crystalline remaining content in amorphous solid dispersions produced by HME. Principal Component Analysis (PCA) and Partial Least Squares (PLS) regression were performed on preprocessed data and tended towards the same conclusions: for the backscattering Raman results, the use of the DuoScan™ mode improved the PCA and PLS results, due to a larger analyzed sampling volume. For the transmission Raman results, the determination of low crystalline percentages was possible and the best regression model was obtained using this technique. Indeed, the latter acquired spectra through the whole sample volume, in contrast with the previous surface analyses performed using the backscattering mode. This study consequently highlighted the importance of the analyzed sampling volume. [less ▲]

Detailed reference viewed: 42 (6 ULiège)
Full Text
Peer Reviewed
See detailChapter 11 - Validation of Supercritical Fluid Chromatography Methods
Dispas, Amandine ULiege; Lebrun, Pierre ULiege; Hubert, Philippe ULiege

in Poole, Colin (Ed.) Supercritical Fluid Chromatography - Handbook in Separation Science (2017)

Method validation is the process of proving that an analytical method is acceptable for its intended purpose. The present chapter defines the validation criteria described in regulatory documents. Despite ... [more ▼]

Method validation is the process of proving that an analytical method is acceptable for its intended purpose. The present chapter defines the validation criteria described in regulatory documents. Despite the abundance of guidelines, the conclusion about method validity remains confused. In this context, the state-of-the-art validation methodology named total error approach is briefly explained as the methodology that should be followed for all method validations. Finally, a review of literature presents quantitative development and validation of supercritical fluid chromatography (SFC) methods considering a wide range of applications and analytical fields. [less ▲]

Detailed reference viewed: 53 (7 ULiège)
Full Text
Peer Reviewed
See detailCombination of Partial Least Squares regression and Design of Experiments to model the retention of pharmaceuticals in Supercritical Fluid Chromatography
Andri, Bertyl ULiege; Dispas, Amandine ULiege; Marini Djang'Eing'A, Roland ULiege 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 ▲]

Detailed reference viewed: 29 (7 ULiège)
Full Text
Peer Reviewed
See detailOptimization and validation of a fast Supercritical Fluid Chromatography method for the quantitative determination of vitamin D3 and its related impurities.
Andri, Bertyl ULiege; Lebrun, Pierre ULiege; Dispas, Amandine ULiege 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 ▲]

Detailed reference viewed: 46 (8 ULiège)
Full Text
Peer Reviewed
See detailContinuous Production of Itraconazole-based Solid Dispersions by Hot Melt Extrusion: Preformulation, Optimization and Design Space Determination.
Thiry, Justine ULiege; Lebrun, Pierre; Vinassa, Chloé et al

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

Detailed reference viewed: 70 (15 ULiège)
Full Text
Peer Reviewed
See detailQualité des médicaments antipaludéens et caractéristiques des pharmacies des territoires périurbains de Kinshasa
Mavungu Landu, Don Jethro ULiege; Liégeois, Sophie; Manzambi Kuwekita, Joseph ULiege 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 ▲]

Detailed reference viewed: 292 (19 ULiège)
Full Text
See detailL’Assurance Qualité dans un laboratoire
Marini Djang'Eing'A, Roland ULiege; Widart, Joëlle ULiege; Hubert, Philippe ULiege

Learning material (2016)

Detailed reference viewed: 54 (10 ULiège)