Counterfeit anti-infective drugs

Newton, Paul N.; Green, Michael D.; Fernández, Facundo M.; Day, Nicholas P. J.; White, Nicholas J.

doi:10.1016/s1473-3099(06)70581-3

Cited by 304 publications

(310 citation statements)

References 60 publications

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“…[15][16][17] A study of artesunate content in tablets sampled from pharmacies in Kumasi, Ghana, in 2008, showed varied contents ranging from 47.9% to 99.9% with only 17.6% passing for content of active ingredients by the European Pharmacopoeia standards. 18 In this study, 20 of 24 (83.3%) samples from the market passed the assay for content; they contained the active ingredients indicated by the manufacturers and in the requisite amounts as indicated by the USP.…”

Section: Resultsmentioning

confidence: 99%

Artemether–Lumefantrine Concentrations in Tablets and Powders from Ghana Measured by a New High-Performance Liquid Chromatography Method

Debrah

Nettey

Miltersen

et al. 2016

The American Society of Tropical Medicine and Hygiene

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Abstract. We developed and validated a new analytical method for the simultaneous quantification of artemether and lumefantrine in fixed-dose tablets and powders for reconstitution into pediatric suspensions (PSs). The method showed linearity (r 2 > 0.9947), precision (coefficient of variation < 2%), accuracy (deviation of mean from actual concentrations < 4%), and specificity (peak purities > 99%). The validated method was used to analyze 24 batches of fixed-dose tablets and PSs of artemether and lumefantrine. Of the samples, 23 were obtained using convenience sampling of commonly available brands within Accra in Ghana and one was obtained from Aarhus University Hospital. In all, 83.3% (confidence interval: 80-120%) passed for both artemether and lumefantrine contents, 16.7% failed by the U.S. Pharmacopoeia standards, 8.3% failed for one content, and 8.3% failed for both contents. All four products (16.7%) that failed were PSs, and two (8.3%) showed higher levels of artemether than prescribed (222% and 756%).

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Section: Resultsmentioning

confidence: 99%

Artemether–Lumefantrine Concentrations in Tablets and Powders from Ghana Measured by a New High-Performance Liquid Chromatography Method

Debrah

Nettey

Miltersen

et al. 2016

The American Society of Tropical Medicine and Hygiene

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“…2 The World Health Organisation (WHO) estimates that only a few countries have fully functional drug regulatory systems. 19 Even if efforts are being made, in many SSA countries, relatively simple chromatographic or pharmacopeial methods for quality verification are not routinely available 34 or used effectively. 35 Although drug registration is normally a prerequisite for purchase in resource-limited countries, authorization to register a medicine is often granted based on a simple review of documents.…”

Section: Discussionmentioning

confidence: 99%

Influence of Tropical Climate Conditions on the Quality of Antihypertensive Drugs from Rwandan Pharmacies

Twagirumukiza¹,

Cosijns²,

Pringels³

et al. 2009

The American Journal of Tropical Medicine and Hygiene

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Abstract. The objective of this study was to assess the quality of antihypertensive drugs and to investigate the influence of tropical storage conditions. Drug content and in vitro dissolution tests were performed on 10 test formulations (from Rwanda) and 6 reference formulations (from Belgium or France) after purchase and after 6-month storage under long-term (25 ± 2°C and 60 ± 5% relative humidity [RH]) and accelerated (40 ± 2°C and 75 ± 5% RH) testing conditions. Twenty percent of test formulations were of substandard content at the time of purchase. After 6 months at accelerated testing conditions, 7 of 10 test formulations were substandard in content and 8 were substandard for the combined criteria of drug content and dissolution, whereas no reference drug became substandard. This study shows that, apart from some drugs being already substandard from purchase, accelerated testing conditions (simulating tropical climate) have deleterious effects on the majority of antihypertensive drug formulations found in the Rwandan market.

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“…Due to its high cost and demand, one pharmaceutical that has been highly counterfeited is the oral antimalarial artesunate [21]. Artemisinin-derived antimalarial drugs such as artemether, arteether, dihydroartemisinin, and artesunate, as mono-therapies, or in combination with co-drugs such as lumefantine and mefloquine are currently the only effective treatment for multidrug resistant Plasmodium falciparum malaria [21] in many parts of Asia and Africa. Recently discovered fake artesunate samples have been shown to contain small subtherapeutic quantities of the correct active ingredient, possibly introduced to defeat current colorimetric authentication tests in use in the field [7,22].…”

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confidence: 99%

mentioning

confidence: 99%

Direct quantitation of active ingredients in solid artesunate antimalarials by noncovalent complex forming reactive desorption electrospray ionization mass spectrometry

Nyadong

Late

Green

et al. 2008

J. Am. Soc. Mass Spectrom.

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The direct quantitation of active ingredients in solid pharmaceutical tablets by desorption electrospray ionization mass spectrometry (DESI MS) is complicated by the dependence of the DESI signal on variables such as spray angles and distances, morphological sample properties, and the difficulty of properly incorporating an internal standard. Here, a DESI MS method for the direct quantitative screening of widely counterfeited antimalarial tablets containing artesunate is presented. This method is based on reactive DESI, where analyte desorption and ionization occur by the formation of noncovalent complexes between alkylamine molecules in the DESI spray solution and artesunate molecules exposed on the sample surface in the open air. For quantitation purposes, the internal standard d 4 -artesunic acid was synthesized by esterification of d 4 -succinic anhydride and dihydroartemisinin, and homogeneously dispersed on the tablet surface via a controlled deposition procedure. The analyte-to-internal standard signal intensity ratio was observed to be largely independent of all DESI variables, only showing dependence on tablet hardness. Analysis of artesunate tablet standards prepared with known amounts of the active ingredient in the 0.02 to 0.32 mg artesunate mg Ϫ1 tablet range resulted in a calibration curve with good linearity (r ϭ 0.9985). Application of this method to the direct quantitation of genuine artesunate tablets from Vietnam showed a 6% (n ϭ 4) precision and 94% accuracy after the spectral data were corrected for tablet hardness. (J Am Soc Mass Spectrom 2008, 19, 380 -388) © 2008 American Society for Mass Spectrometry T he development of methodologies that allow the quantitative determination of physiologically active an a a aly l l te y y s in i i complex matrices is an ongoing trend in analytical and biological mass spectrometry. In this sense, high-performance liquid chromatography (LC) coupled to mass spectrometry (MS) via electrospray ionization (ESI), or atmospheric pressure chemical ionization (APCI), has become the de facto routine quantitative analytical tool in clinical chemistry, drug discovery, and proteomics [1][2][3]. Although LC-MS is characterized by one of the highest peak capacities of contemporary analytical separation methodologies [4], alternative techniques are constantly being developed to improve sample throughput, eliminate crosscontamination, and increase reproducibility.The emergence of ambient desorption ionization techniques such as desorption electrospray ionization (DESI) [5], direct analysis in real time (DART) [6], and others has enabled the direct sampling of complex solid materials in the open air with minimal or no sample preparation. DESI makes use of a pneumatically assisted electrospray jet, which is directed unto the sample surface to desorb the condensed-phase analyte(s). Following desorption, the analyte-containing charged droplets scattered off the sample surface are sampled by a mass spectrometer. DESI enables the analysis of materials over a large mass range an...

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Counterfeit anti-infective drugs

Cited by 304 publications

References 60 publications

Artemether–Lumefantrine Concentrations in Tablets and Powders from Ghana Measured by a New High-Performance Liquid Chromatography Method

Artemether–Lumefantrine Concentrations in Tablets and Powders from Ghana Measured by a New High-Performance Liquid Chromatography Method

Influence of Tropical Climate Conditions on the Quality of Antihypertensive Drugs from Rwandan Pharmacies

Direct quantitation of active ingredients in solid artesunate antimalarials by noncovalent complex forming reactive desorption electrospray ionization mass spectrometry

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