Routine quality control of medicines in developing countries: Analytical challenges, regulatory infrastructures and the prevalence of counterfeit medicines in Tanzania

Höllein, Ludwig; Kaale, Eliangiringa; Mwalwisi, Yonah H.; Schulze, Marco H.; Holzgrabe, Ulrike

doi:10.1016/j.trac.2015.11.009

Cited by 61 publications

(50 citation statements)

References 63 publications

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“…Moreover, only small sample volumes are needed, there is only a low consumption of solvents, and no expensive columns with special modifications of the stationary phase are required. In view of the urgent need of implementing modern analytical techniques in low‐ and middle‐income countries , these features make CE an attractive cost‐effective technology for quality analysis and thus, for the detection of falsified and substandard medicines in laboratories with limited resources and infrastructural restrictions. Of note, compact and robust instruments have been constructed recently which are suitable of being used in tropical environments .…”

Section: Introductionmentioning

confidence: 99%

Capillary zone electrophoresis for the determination of amodiaquine and three of its synthetic impurities in pharmaceutical formulations

et al. 2018

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A simple and robust CZE method was developed for the separation and quantification of the antimalarial compound amodiaquine as well as three of its synthetic impurities at a concentration equal to or lower than 0.5%. For capillary electrophoresis, a fused-silica capillary, a background electrolyte of 100 mM sodium phosphate buffer at a pH value of 6.2, a voltage of +20 kV, and a detection wavelength of 220 nm were used, allowing the determination of the analytes within 20 min. The method was validated according to the guideline Q2(R1) of the International Council for Harmonization with respect to linearity, precision, accuracy, limit of detection and limit of quantification, and was successfully applied to evaluate the quality of drug samples collected in the Democratic Republic of the Congo. Quantitative analysis results obtained by the CZE method were compared to those obtained with the contemporary HPLC method described in The International Pharmacopoeia.

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Section: Introductionmentioning

confidence: 99%

Capillary zone electrophoresis for the determination of amodiaquine and three of its synthetic impurities in pharmaceutical formulations

et al. 2018

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“…These dissimilarities could be explained by the sample collection techniques and the analytical procedures used, but also by the drug legislation and the law enforcement policies, which differ from one country to another. An improved quality control system will reduce the number of falsified and substandard medicines as it has recently been shown in Tanzania …”

Section: Discussionmentioning

confidence: 97%

“…An improved quality control system will reduce the number of falsified and substandard medicines as it has recently been shown in Tanzania. 38…”

Section: Hplc Analysismentioning

confidence: 99%

Quality of the antimalarial medicine artemether – lumefantrine in 8 cities of the Democratic Republic of the Congo

Mufusama

Ioset

Feineis

et al. 2018

Drug Testing and Analysis

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In the context of post-marketing surveillance supporting public-health authorities to take evidence-based decisions to fight the spread of poor-quality medicines, the quality of antimalarial artemether-lumefantrine (AL) medicines was assessed in the Democratic Republic of the Congo (DRC). A total of 150 samples of AL-containing products was collected from private pharmaceutical outlets in 8 main cities: Goma, Kikwit, Kinshasa, Kisangani, Lubumbashi, Matadi, Mbandaka, and Mbuji-Mayi. All drug samples were successively analyzed by visual inspection, thin-layer chromatography (TLC), and high-performance liquid chromatography (HPLC) following The International Pharmacopoeia. Of the 150 collected drug samples, 3 (2%) failed the visual inspection as they had shelf lives different from those of other samples with the same brand name. Four samples (2.7%) did not pass the TLC test as they contained only 1 or even none of the 2 declared active pharmaceutical ingredients (APIs). HPLC assays showed that 46 (30.7%) samples had artemether contents below 90% and 17 (11.3%) above 110% of the content claimed on the label. For lumefantrine, 32 (21.7%) samples had contents below 90%, and 8 (5.3%) had contents above 110%. This survey in DRC gives evidence that poor-quality antimalarial medicines are widely present. Based on 3 detection techniques, the study shows the necessity to equip developing countries with modern techniques such as HPLC, which, if combined with affordable techniques like TLC, could provide a pertinent analytical strategy to combat drug counterfeiting and poor manufacturing.

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“…Les résultats obtenus attestent de la bonne qualité des médicaments à base de chlorhydrate de doxorubicine utilisés dans les structures sanitaires de la Côte d'Ivoire. Cette méthode contribuerait à assurer la conformité des lots de médicaments à base de chlorhydrate de doxorubicine avant l'administration aux malades et à détecter les contrefaçons qui pourraient circuler en milieux hospitaliers (Höllein et al, 2016 ;Krakowska et al, 2016). Elle pourrait concourir à l'instauration systématique de contrôle postdistribution de médicaments anticancéreux à base de chlorhydrate de doxorubicine de Côte d'Ivoire.…”

Section: Conditions Opératoiresunclassified

Validation d’une méthode de dosage CLHP de l’anticancéreux chlorhydrate de doxorubicine dans des poudres lyophilisées pour préparation injectable

Kpaibe¹,

Amin²,

Soumahoro³

et al. 2017

Int. J. Bio. Chem. Sci

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Routine quality control of medicines in developing countries: Analytical challenges, regulatory infrastructures and the prevalence of counterfeit medicines in Tanzania

Cited by 61 publications

References 63 publications

Capillary zone electrophoresis for the determination of amodiaquine and three of its synthetic impurities in pharmaceutical formulations

Capillary zone electrophoresis for the determination of amodiaquine and three of its synthetic impurities in pharmaceutical formulations

Quality of the antimalarial medicine artemether – lumefantrine in 8 cities of the Democratic Republic of the Congo

Validation d’une méthode de dosage CLHP de l’anticancéreux chlorhydrate de doxorubicine dans des poudres lyophilisées pour préparation injectable

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