APPLICATION OF DESIGN SPACE OPTIMIZATION STRATEGY TO THE DEVELOPMENT OF LC METHODS FOR SIMULTANEOUS ANALYSIS OF 18 ANTIRETROVIRAL MEDICINES AND 4 MAJOR EXCIPIENTS USED IN VARIOUS PHARMACEUTICAL FORMULATIONS

peer reviewedtAs 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

Préparation des échantillons pharmaceutiques

Fournir des bases et une information générale sur le principe de la préparations des spécialités pharmaceutiques avant leur analyse dans le cadre d'un contrôle de qualité. Donner les règles d'acceptation de leur conformité

Simple LC Isocratic Methods Development, Validation, and Application in the Analysis of Poor Quality Antimalarial Medicines

peer reviewedLiquid chromatographic methods in isocratic mode for the analysis of poor quality medicines are privileged due to their simplicity and facility in methods development. They are generally fast; do not need to be re-equilibrated between sample injections; have larger flexibility with acceptable changes on different column dimensions; and are applicable to LC systems equipped with simple or high developed pumps. In this study, we focused on developing simple isocratic methods using classical mobile phase composed by methanol and ammonium formate buffer for the analysis of most common antimalarial medicines marketed in malaria endemic countries and susceptible of being counterfeit/falsified, substandard and degraded. The selected medicines were quinine and related cinchona alkaloids in tablets and injectable forms; artemether/ lumefantrine tablets; and artemisinin compounds (arteether, artemether, and artesunate) in injectable forms. The current methods were developed thanks to simple methodological approach consisting in sequential isocratic runs through adjustment or adaptation of existing methods to obtain optimal analytical conditions without complex design of experiments that might be long and costly. Then, the new methods presented shorter analysis time; allowed increase of sample analysis throughput; and obviously consumed little mobile phase solvents on classical analytical columns: 50 - 250 mm of length (L), 4.6 mm of internal diameter (I.D.), and 3.5 - 5.0 μm of particle size (dp)

QUALITY ASSESSMENT OF MEDICINES MARKETED IN RWANDA, July-Oct. 2011

Développement, Validation et Transfert de méthodes analytiques génériques pour lutter contre la contrefaçon des médicament

FALSIFICATION DES MÉDICAMENTS EN MILIEU PÉRIURBAIN : TRISTE RÉALITÉ

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Comparative study of the in-vitro dissolution profiles of generic and originator quinine sulfate by using High Performance Liquid Chromatography

peer reviewedIntroduction : 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

Falsification of drugs in peri-urban areas: a sad reality

peer reviewedFalsifying 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

Generic screening chromatographic methods to fight against poor quality medicines

peer reviewedPoor 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.Projet Falsification/Contrefaço