Integration of Novel Low-Cost Colorimetric, Laser Photometric, and Visual Fluorescent Techniques for Rapid Identification of Falsified Medicines in Resource-Poor Areas: Application to Artemether–Lumefantrine

The availability of falsified antimalarial drugs can be reduced with effective drug regulatory agencies and proper enforcement. Fundamental to these agencies taking action, rapid identification must be made as soon as they appear in the market place. Since falsified antimalarials occur mostly in developing countries, performing drug analysis presents itself with unique challenges. A fundamental factor in choosing a useful technique is affordability and simplicity. Therefore, we suggest a three-tiered drug evaluation strategy for identifying a falsified drug in resource-poor areas. Tier I is a simple comparison of a tablet's weight and dimensions with official specifications. Tier II uses inexpensive photometric devices (laser and fluorescence) to evaluate a tablet. Suspicious samples from Tier I and II assessments are then subjected to a colorimetric assay for active ingredients identification and quantification. In this article, we evaluate a novel colorimetric assay for the simultaneous assessment of both lumefantrine and artemether in co-formulated Coartem™ tablets, and integrate the method with two novel, low-cost, fluorescence and laser photometric devices. Image analysis software is used for the assessments. Although artemether–lumefantrine is used as an example, the strategy may be adapted to other medicines.

[1]  Nicola Ranieri,et al.  Evaluation of a New Handheld Instrument for the Detection of Counterfeit Artesunate by Visual Fluorescence Comparison , 2014, The American journal of tropical medicine and hygiene.

[2]  M. Gatton,et al.  Prevalence of asymptomatic malaria and bed net ownership and use in Bhutan, 2013: a country earmarked for malaria elimination , 2014, Malaria Journal.

[3]  P. Newton,et al.  Falsified medicines in Africa: all talk, no action. , 2014, The Lancet. Global health.

[4]  A. Stergachis,et al.  Technologies for Detecting Falsified and Substandard Drugs in Low and Middle-Income Countries , 2014, PloS one.

[5]  H. Nettey,et al.  Quality Assessment of Artemether/Lumefantrine Tablets Sampled from Pharmacies in Accra, Using the MVHimagePCv8.exe Color Software , 2013 .

[6]  L. Gostin,et al.  Countering the Problem of Falsified and Substandard Drugs , 2013 .

[7]  Patrick Lukulay,et al.  Assessment of the performance of a handheld Raman device for potential use as a screening tool in evaluating medicines quality. , 2013, Journal of pharmaceutical and biomedical analysis.

[8]  P. Newton,et al.  Evaluation of a rapid colorimetric field test to assess the effective life of long-lasting insecticide-treated mosquito nets in the Lao PDR , 2013, Malaria Journal.

[9]  Paul N Newton,et al.  Poor-quality antimalarial drugs in southeast Asia and sub-Saharan Africa. , 2012, The Lancet. Infectious diseases.

[10]  P. Siba,et al.  Malaria case management in Papua New Guinea following the introduction of a revised treatment protocol , 2012, Malaria Journal.

[11]  P. Newton,et al.  Poor quality vital anti-malarials in Africa - an urgent neglected public health priority , 2011, Malaria Journal.

[12]  Paul N. Newton,et al.  Poor quality drugs: grand challenges in high throughput detection, countrywide sampling, and forensics in developing countries. , 2011, The Analyst.

[13]  Kimberly Hess,et al.  Anti-malarial drug quality in Lagos and Accra - a comparison of various quality assessments , 2010, Malaria Journal.

[14]  M. Malet‐Martino,et al.  Counterfeit drugs: analytical techniques for their identification , 2010, Analytical and bioanalytical chemistry.

[15]  H. Kaur,et al.  Simple Field Assays to Check Quality of Current Artemisinin-Based Antimalarial Combination Formulations , 2009, PloS one.

[16]  F. Atieli,et al.  Rapid colorimetric field test to determine levels of deltamethrin on PermaNet® surfaces: association with mosquito bioactivity , 2009, Tropical medicine & international health : TM & IH.

[17]  O. Gaye,et al.  Quality of Artesunate Tablets Sold in Pharmacies in Kumasi, Ghana , 2008 .

[18]  Facundo M Fernandez,et al.  Detecting counterfeit antimalarial tablets by near-infrared spectroscopy. , 2008, Journal of pharmaceutical and biomedical analysis.

[19]  K. Silamut,et al.  Clinically uncomplicated Plasmodium falciparum malaria with high schizontaemia: A case report , 2008, Malaria Journal.

[20]  K. A. Hall,et al.  Fast detection and identification of counterfeit antimalarial tablets by Raman spectroscopy , 2007 .

[21]  Henry Nettey,et al.  Use of refractometry and colorimetry as field methods to rapidly assess antimalarial drug quality. , 2007, Journal of pharmaceutical and biomedical analysis.

[22]  P. Newton,et al.  Counterfeit artesunate antimalarials in southeast Asia , 2003, The Lancet.

[23]  M. Green,et al.  Authentication of artemether, artesunate and dihydroartemisinin antimalarial tablets using a simple colorimetric method , 2001, Tropical medicine & international health : TM & IH.

[24]  Stephane Proux,et al.  Fake artesunate in southeast Asia , 2001, The Lancet.

[25]  M. Green,et al.  A colorimetric field method to assess the authenticity of drugs sold as the antimalarial artesunate. , 2000, Journal of pharmaceutical and biomedical analysis.

[26]  N. White,et al.  Artemisinin: current status. , 1994, Transactions of the Royal Society of Tropical Medicine and Hygiene.

[27]  M. Braga,et al.  Exploratory Data Analysis , 2018, Encyclopedia of Social Network Analysis and Mining. 2nd Ed..

[28]  John W. Tukey,et al.  Exploratory data analysis , 1977, Addison-Wesley series in behavioral science : quantitative methods.

[29]  THE WORLD HEALTH ORGANIZATION , 1954 .

[30]  B ZAK,et al.  A new method for the direct determination of serum cholesterol. , 1953, The Journal of laboratory and clinical medicine.

[31]  P. Newton,et al.  Antimalarial drug quality: Methods to detect suspect drugs , 2010 .

[32]  Organización Mundial de la Salud Guidelines for the treatment of malaria , 2010 .

[33]  Richard W. O. Jähnke,et al.  A Concise Quality Control Guide on Essential Drugs and other Medicines , 2009 .