References of "Dispas, Amandine"
     in
Bookmark and Share    
Full Text
Peer Reviewed
See detailAnalytical Tools and Strategic Approach to Detect Poor Quality Medicines, Identify Unknown Components, and Timely Alerts for Appropriate Measures: Case Study of Antimalarial Medicines
Habyalimana, Védaste ULg; Mbinze Kindenge, Jérémie; Kalenda Tshilombo, Nicodème ULg et al

in American Journal of Analytical Chemistry (2015), 6

Nowadays, the circulation of poor quality medicines is becoming an alarming worldwide phenomenon with serious public health and socio-economic concerns. The situation is particularly critical in ... [more ▼]

Nowadays, the circulation of poor quality medicines is becoming an alarming worldwide phenomenon with serious public health and socio-economic concerns. The situation is particularly critical in developing countries where drug quality assurance and regulatory systems for drug manufacturing, importation, distribution and sales are weak. A sustained vigilance on poor quality medicines that regroup counterfeit/falsified, substandard and degraded medicines is therefore required to ensure patient safety and genuine medicines integrity. A case situation is illustrated including a strategic approach and analytical tools that were found useful to detect poor quality medicines, identify unknown components, and timely alerts for appropriate measures against the spread of those harmful products. Several suspected medicines randomly sampled in several strategic Rwandan areas were firstly check-controlled by means of visual inspection and then applying several analytical techniques from simple to more complex ones. The following medicines were studied: quinine sulfate tablets, artemisinin-based combination tablets, and artesunate powders for injection. Taking into account the pharmaceutical forms and the chemical characteristics, the following tests were applied: uniformity of mass, friability, disintegration, fluorescence, identification and assay. They were followed by more complex analytical techniques that allowed more comprehension of abnormal findings among which the presence of a wrong active pharmaceutical ingredient in quinine sulfate tablets which is mainly discussed in this paper to illustrate a strategic approach and various analytical tools that can be used in detecting and identifying unknown component in poor quality medicines. [less ▲]

Detailed reference viewed: 6 (0 ULg)
Full Text
See detailQualification de l'équipement
Dispas, Amandine ULg; Mbinze Kindenge, Jérémie ULg; Lecomte, Frederic ULg et al

Learning material (2015)

Detailed reference viewed: 60 (0 ULg)
Full Text
Peer Reviewed
See detailFalsification des médicaments en milieu périurbain : triste réalité
Marini Djang'Eing'A, Roland ULg; Kalenda Tshilombo, Nicodème ULg; Habyalimana, Védaste ULg et al

in Bogaert, Jan; Halleux, Jean-Marie (Eds.) Territoires périurbains. Développement, enjeux et prespectives dans les pays du Sud (2015)

Falsifying drugs constitutes a scourge, a danger and a threat to public health. If the situation is already alarming at the global level, what could be expected regarding the peri-urban areas of ... [more ▼]

Falsifying drugs constitutes a scourge, a danger and a threat to public health. If the situation is already alarming at the global level, what could be expected regarding the peri-urban areas of developing countries? In order to better understand the situation in these areas and to improve the consciousness and involvement of the people living in those areas, a study was carried out to evaluate the current status of the pharmaceutical health situation of some cities in Central East and West Africa. The results illustrate the complexity to set up an adequate pharmaceutical system in these areas that seem to escape to the control of the official health authorities. On the other hand, the analytical results carried out by means of generic analytical methods on antibiotic, antimalarial and non-steroidal anti-inflammatory drugs sampled in the peri-urban areas, are revelatory and confirm the sad reality of false drugs in those areas. [less ▲]

Detailed reference viewed: 23 (9 ULg)
Full Text
Peer Reviewed
See detailEvaluation of the quantitative performances of Supercritical Fluid Chromatography : from method development to validation
Dispas, Amandine ULg; Lebrun, Pierre ULg; Ziemons, Eric ULg et al

in Journal of Chromatography. A (2014), 1353(Method Validation), 78-88

Recently, the number of papers about SFC increased drastically but scientists did not truly focus their work on quantitative performances of this technique. In order to prove the potential of UHPSFC, the ... [more ▼]

Recently, the number of papers about SFC increased drastically but scientists did not truly focus their work on quantitative performances of this technique. In order to prove the potential of UHPSFC, the present work discussed about the different steps of the analytical life cycle of a method: from development to validation and application. Moreover, the UHPSFC quantitative performances were evaluated in comparison with UHPLC, which is the main technique used for quality control in the pharmaceutical industry and then could be considered as a reference. The methods were developed using Design Space strategy, leading to the optimization of robust method. In this context, when the Design Space optimization shows guarantee of quality, no more robustness study is required prior to the validation. Then, the methods were geometrically transferred in order to reduce the analysis time. The UHPSFC and UHPLC methods were validated based on the total error approach using accuracy profile. Even if UHPLC showed better precision and sensitivity, UHPSFC method is able to give accurate results in a dosing range larger than the 80–120% range required by the European Medicines Agency. Consequently, UHPSFC results are valid and could be used for the control of active substance in a finished pharmaceutical product. Finally, UHPSFC validated method was used to analyse real samples and gave similar results than the reference method (UHPLC). [less ▲]

Detailed reference viewed: 72 (26 ULg)
Full Text
Peer Reviewed
See detailEvaluation of SFC interest for the determination of cholecalciferol and its impurities in pharmaceuticals
Andri, Bertyl ULg; Dispas, Amandine ULg; Klinkenberg, Régis et al

Poster (2014, June 23)

Detailed reference viewed: 56 (3 ULg)
Full Text
Peer Reviewed
See detailMéthodes chromatographiques génériques de criblage pour lutter contre les médicaments de qualité inférieure
Habyalimana, Védaste; Kalenda Tshilombo, Nicodème; Dispas, Amandine ULg et al

in Spectra Analyse (2014), 43

Poor quality medicines are a danger and a threat to public health. In this context, several generic analytical methods have been developed to screen molecules of interest grouped by pharmacological class ... [more ▼]

Poor quality medicines are a danger and a threat to public health. In this context, several generic analytical methods have been developed to screen molecules of interest grouped by pharmacological class using an innovative strategy based on design of experiments followed in some cases by independent component analysis and calculation of design space. Once validated via the classical total error measurement approach, these methods were applied to quantify antimalarial, non-steroidal anti-inflammatory and antibiotic medicines. Alarming results regarding the dosage of these drugs widely used by people confirm the need to fight against this scourge. [less ▲]

Detailed reference viewed: 38 (9 ULg)
Full Text
Peer Reviewed
See detailRobust method optimization strategy – a useful tool for method transfer: the case of SFC
Dispas, Amandine ULg; Lebrun, Pierre ULg; Andri, Bertyl ULg et al

in Journal of Pharmaceutical & Biomedical Analysis (2014), 88

The concept of Quality by Design (QbD) is now well established in pharmaceutical industry and should be applied to the development of any analytical methods. In this context, the key concept of Design ... [more ▼]

The concept of Quality by Design (QbD) is now well established in pharmaceutical industry and should be applied to the development of any analytical methods. In this context, the key concept of Design Space (DS) was introduced in the field of analytical method optimization. In chromatographic words, the DS is the space of chromatographic conditions that will ensure the quality of peaks separation, thus DS is a zone of robustness. In the present study, the interest of robust method optimization strategy was investigated in the context of direct method transfer from sending to receiving laboratory. The benefit of this approach is to speed up the method life cycle by performing only one quantitative validation step in the final environment of method use. A Supercritical Fluid Chromatography (SFC) method previously developed was used as a case study in this work. Moreover, the interest of geometric transfer was investigated simultaneously in order to stress a little bit more the transfer exercise and, by the way, emphasize the additional benefit of DS strategy in this particular context. Three successful transfers were performed on two column geometries. In order to compare original and transferred methods, the observed relative retention times (RT) were modelled as a function of the predicted relative RT and of the method type (original or transferred). The observed relative RT of the original and transferred methods are not statistically different and thus the method transfer is successfully achieved thanks to the robust optimization strategy. Furthermore, the analytical method was improved considering analysis time (reduced five times) and peak capacity (increased three times). To conclude, the advantage of using a DS strategy implemented for the optimization and transfer of SFC method was successfully demonstrated in this work. [less ▲]

Detailed reference viewed: 85 (20 ULg)
Full Text
Peer Reviewed
See detailApplication of an innovative design space optimization strategy to thedevelopment of LC methods for the simultaneous screening of antibiotics to combat poor quality medicines
Mbinze Kindenge, Jérémie ULg; Dispas, Amandine ULg; Lebrun, Pierre ULg et al

in Journal of Pharmaceutical & Biomedical Analysis (2013), 85

The poor quality of medicines is a crucial problem of public health. Therefore, it is important to haveanalytical tools to attend decisions of the legal authorities while combating this offense. In this ... [more ▼]

The poor quality of medicines is a crucial problem of public health. Therefore, it is important to haveanalytical tools to attend decisions of the legal authorities while combating this offense. In this context,the main objective of this study was to develop generic methods able to trace, screen and determineseveral antibiotics and common associated molecules by mean of liquid chromatographic techniques.For that purpose, an innovative Design Space optimization strategy was applied, targeting 16 antibioticsand 3 beta-lactamase inhibitors. The robustness of the developed method allowed using its use in anenvironment where operational factors such as temperature are not easy to control and eased its trans-fer to Ultra High Performance Liquid Chromatography. To demonstrate its ability to quantify the targetedmolecules, the developed and transferred method was fully validated for two active ingredients com-monly used in association, sulbactam and ceftriaxone, using the accuracy profile as decision tool. Basedon this successful step, the method was then used for the quantitative determination of these two activeingredients in three pharmaceutical brands marketed in the Democratic Republic of Congo. Two out ofthe three pharmaceutical products did not comply with the specifications [less ▲]

Detailed reference viewed: 85 (29 ULg)
Full Text
Peer Reviewed
See detailRobust SFC method optimization using design space strategy
Dispas, Amandine ULg; Lebrun, Pierre ULg; Hubert, Philippe ULg

Conference (2013, October)

Detailed reference viewed: 30 (4 ULg)