ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
-
1
WHO, 1999. Counterfeit Drugs. Guidelines for the Development of Measures to Combat Counterfeit Drugs. Available from http://www.who.int/medicines/publications/counterfeitguidelines/en/.
-
2
O’Brien KL, Selanikio JD, Hecdivert C, Placide MF, Louis M, Barr DB, Barr JR, Hospedales CJ, Lewis MJ, Schwartz B, Philen RM, St Victor S, Espindola J, Needham LL, Denerville K, 1998. Epidemic of pediatric deaths from acute renal failure caused by diethylene glycol poisoning. JAMA 279 :1175–1180.
-
3
Hanif M, Mobarak MR, Ronan A, Rahman D, Donovan JJ, Bennish ML, 1995. Fatal renal-failure caused by diethylene glycol in paracetamol elixir: the Bangladesh epidemic. BMJ 311 :88–91.
-
4
Newton PN, White NJ, Rozendaal JA, Green MD, 2002. Murder by fake drugs: time for international action. BMJ 324 :800–801.
-
5
Cockburn R, Newton PN, Agyarko EK, Akunyili D, White NJ, 2005. The global threat of counterfeit drugs: why industry and governments must communicate the dangers. PLoS Med 2 :100–106.
-
6
Newton P, Proux S, Green M, Smithuis F, Rozendaal J, Prakongpan S, Chotivanich K, Mayxay M, Looareesuwan S, Farrar J, Nosten F, White NJ, 2001. Fake artesunate in southeast Asia. Lancet 357 :1948–1950.
-
7
Newton PN, Green M, Fernandez FM, Day NP, White NJ, 2006. Counterfeit anti-infective drugs. Lancet Infect Dis. 6 :602–613.
-
8
Basco LK, 2004. Molecular epidemiology of malaria in Cameroon. XIX. Quality of antimalarial drugs used for self-medication. Am J Trop Med Hyg 70 :245–250.
-
9
Daviss B, 2005. Malaria, science, and social responsibility. Scientist 19 :42–43.
-
10
White NJ, 2004. Antimalarial drug resistance. J Clin Invest 113 :1084–1092.
-
11
van Agtmael MA, Eggelte TA, van Boxtel CJ, 1999. Artemisinin drugs in the treatment of malaria: From medicinal herb to registered medication. Trends Pharmacol Sci 20 :199–205.
-
12
Aldhous P, 2005. Murder by medicine. Nature 434 :132–136.
-
13
Dondorp AM, Newton PN, Mayxay M, van Damme W, Smithuis FM, Yeung S, Petit A, Lynam AJ, Johnson A, Hien TT, McGready R, Farrar JJ, Looareesuwan S, Day NPJ, Green MD, White NJ, 2004. Fake antimalarials in southeast Asia are a major impediment to malaria control: multinational cross-sectional survey on the prevalence of fake antimalarials. Trop Med Int Health 9 :1241–1246.
-
14
Newton PN, Dondorp A, Green M, Mayxay M, White NJ, 2003. Counterfeit artesunate antimalarials in southeast Asia. Lancet 362 :169.
-
15
Newton PN, McGready R, Fernandez FM, Green MD, Sunjio M, Bruneton C, Phanouvong S, Millet P, Whitty CJ, Talisuna AO, Proux S, Christophel EM, Malenga G, Singhasivanon P, Bojang K, Kaur H, Palmer K, Day NPJ, Greenwood BM, Nosten F, White NJ, 2006. Manslaughter by fake artesunate in Asia: will Africa be next? PLoS Med 3 :1–4.
-
16
Green M, Mount DL, Wirtz RA, 2001. Authentication of Artemether, Artesunate and dihydroartemisin antimalarial tablets using a simple colorimetric method. Trop Med Int Health 6 :980–982.
-
17
Lim CK, Lord G, 2002. Current developments in LC-MS for pharmaceutical analysis. Biol Pharm Bull 25 :547–557.
-
18
NIST Scientific and Technical Databases, 2002. Available from http://www.nist.gov/srd/nist1a.htm.
-
19
Vankeirsbilck T, Vercauteren A, Baeyens W, Van der Weken G, Verpoort F, Vergote G, Remon JP, 2002. Applications of Raman spectroscopy in pharmaceutical analysis. TrAC Trends Anal Chem 21 :869–877.
-
20
Massart DL, Vandeginste BG, Buydens LM, De Jong S, Lewi PJ, Smeyers-Verbeke J, 1997. Handbook of Chemometrics and Qualimetrics. Amsterdam: Elsevier.
-
21
World Health Organization, 2006. What Are Substandard Drugs? Available from http://www.who.int/medicines/services/counterfeit/faqs/06/en/.
-
22
Gates P, Kearney G, Jones R, Leadlay P, Staunton J, 1999. Structural elucidation studies of erythromycins by electrospray tandem mass spectrometry. Rapid Commun Mass Spectrom 13 :242–246.
-
23
Wardrop J, Ficker D, Franklin S, Gorski R, 2000. Determination of erythromycin and related substances in enteric-coated tablet formulations by reversed-phase liquid chromatography. J Pharm Sci 89 :1097–1105.
-
24
Allen LV Jr, Popovich NG, Ansel HC, Allen LV, 2004. Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems. Philadelphia: Lippincott Williams and Wilkins.
-
25
Jähnke RW, Küsters G, 2001. Detecting counterfeit drugs-protection against counterfeit medicines using the GPHF-Minilab. Bull Mekong Malaria Forum 8 :118–124.
-
26
Rozendaal J, 2000. Fake antimalarials circulating in Cambodia. Bull Mekong Malaria Forum 7 :62–68.
-
27
United States Pharmacopeia, 2006. Fake Malarials Found in Yunnan Province, China. Available from http://www.uspdqi.org/pubs/other/FakeAntimalarialsinChina.pdf.
-
28
Hartl DL, 2004. The origin of malaria: mixed messages from genetic diversity. Nat Rev Microbiol 2 :15–22.
-
29
Fernandez FM, Cody RB, Green M, Hampton CY, McGready R, Sengaloundeth S, White NJ, Newton PN, 2006. Characterization of solid counterfeit drug samples by desorption electro-spray ionization and direct-analysis-in-real-time coupled to time-of-flight mass spectrometry. Chem Med Chem 1 :702–705.
-
30
Wolff JC, Thomson LA, Eckers C, 2003. Identification of the ‘wrong’ active pharmaceutical ingredient in a counterfeit Hal-fan(TM) drug product using accurate mass electrospray ionisation mass spectrometry, accurate mass tandem mass spectrometry and liquid chromatography/mass spectrometry. Rapid Commun Mass Spectrom 17 :215–221.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 1143 | 1012 | 21 |
| Full Text Views | 399 | 6 | 0 |
| PDF Downloads | 137 | 9 | 0 |
CHARACTERIZATION OF COUNTERFEIT ARTESUNATE ANTIMALARIAL TABLETS FROM SOUTHEAST ASIA
KRYSTYN ALTER HALL
KRYSTYN ALTER HALL
School of Chemistry and Biochemistry, Georgia Institute of Technology, Atlanta, Georgia; Wellcome Trust-Mahosot Hospital-Oxford Tropical Medicine Research Collaboration, Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao People’s Democratic Republic; Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford University, Oxford, United Kingdom; Division of Parasitic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; Laboratory of Analytical Chemistry, Ghent University, Ghent, Belgium; Light Impressions International, Leatherhead, Surrey, United Kingdom; Wellcome Trust-Mahidol University-Oxford Tropical Medicine Research Programme, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
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PAUL N. NEWTON
PAUL N. NEWTON
School of Chemistry and Biochemistry, Georgia Institute of Technology, Atlanta, Georgia; Wellcome Trust-Mahosot Hospital-Oxford Tropical Medicine Research Collaboration, Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao People’s Democratic Republic; Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford University, Oxford, United Kingdom; Division of Parasitic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; Laboratory of Analytical Chemistry, Ghent University, Ghent, Belgium; Light Impressions International, Leatherhead, Surrey, United Kingdom; Wellcome Trust-Mahidol University-Oxford Tropical Medicine Research Programme, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
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MICHAEL D. GREEN
MICHAEL D. GREEN
School of Chemistry and Biochemistry, Georgia Institute of Technology, Atlanta, Georgia; Wellcome Trust-Mahosot Hospital-Oxford Tropical Medicine Research Collaboration, Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao People’s Democratic Republic; Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford University, Oxford, United Kingdom; Division of Parasitic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; Laboratory of Analytical Chemistry, Ghent University, Ghent, Belgium; Light Impressions International, Leatherhead, Surrey, United Kingdom; Wellcome Trust-Mahidol University-Oxford Tropical Medicine Research Programme, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
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MARLEEN DE VEIJ
MARLEEN DE VEIJ
School of Chemistry and Biochemistry, Georgia Institute of Technology, Atlanta, Georgia; Wellcome Trust-Mahosot Hospital-Oxford Tropical Medicine Research Collaboration, Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao People’s Democratic Republic; Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford University, Oxford, United Kingdom; Division of Parasitic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; Laboratory of Analytical Chemistry, Ghent University, Ghent, Belgium; Light Impressions International, Leatherhead, Surrey, United Kingdom; Wellcome Trust-Mahidol University-Oxford Tropical Medicine Research Programme, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
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PETER VANDENABEELE
PETER VANDENABEELE
School of Chemistry and Biochemistry, Georgia Institute of Technology, Atlanta, Georgia; Wellcome Trust-Mahosot Hospital-Oxford Tropical Medicine Research Collaboration, Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao People’s Democratic Republic; Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford University, Oxford, United Kingdom; Division of Parasitic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; Laboratory of Analytical Chemistry, Ghent University, Ghent, Belgium; Light Impressions International, Leatherhead, Surrey, United Kingdom; Wellcome Trust-Mahidol University-Oxford Tropical Medicine Research Programme, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
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DAVID PIZZANELLI
DAVID PIZZANELLI
School of Chemistry and Biochemistry, Georgia Institute of Technology, Atlanta, Georgia; Wellcome Trust-Mahosot Hospital-Oxford Tropical Medicine Research Collaboration, Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao People’s Democratic Republic; Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford University, Oxford, United Kingdom; Division of Parasitic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; Laboratory of Analytical Chemistry, Ghent University, Ghent, Belgium; Light Impressions International, Leatherhead, Surrey, United Kingdom; Wellcome Trust-Mahidol University-Oxford Tropical Medicine Research Programme, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
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MAYFONG MAYXAY
MAYFONG MAYXAY
School of Chemistry and Biochemistry, Georgia Institute of Technology, Atlanta, Georgia; Wellcome Trust-Mahosot Hospital-Oxford Tropical Medicine Research Collaboration, Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao People’s Democratic Republic; Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford University, Oxford, United Kingdom; Division of Parasitic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; Laboratory of Analytical Chemistry, Ghent University, Ghent, Belgium; Light Impressions International, Leatherhead, Surrey, United Kingdom; Wellcome Trust-Mahidol University-Oxford Tropical Medicine Research Programme, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
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ARJEN DONDORP
ARJEN DONDORP
School of Chemistry and Biochemistry, Georgia Institute of Technology, Atlanta, Georgia; Wellcome Trust-Mahosot Hospital-Oxford Tropical Medicine Research Collaboration, Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao People’s Democratic Republic; Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford University, Oxford, United Kingdom; Division of Parasitic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; Laboratory of Analytical Chemistry, Ghent University, Ghent, Belgium; Light Impressions International, Leatherhead, Surrey, United Kingdom; Wellcome Trust-Mahidol University-Oxford Tropical Medicine Research Programme, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
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FACUNDO M. FERNANDEZ
FACUNDO M. FERNANDEZ
School of Chemistry and Biochemistry, Georgia Institute of Technology, Atlanta, Georgia; Wellcome Trust-Mahosot Hospital-Oxford Tropical Medicine Research Collaboration, Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao People’s Democratic Republic; Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford University, Oxford, United Kingdom; Division of Parasitic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; Laboratory of Analytical Chemistry, Ghent University, Ghent, Belgium; Light Impressions International, Leatherhead, Surrey, United Kingdom; Wellcome Trust-Mahidol University-Oxford Tropical Medicine Research Programme, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
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In southeast Asia, the widespread high prevalence of counterfeits tablets of the vital antimalarial artesunate is of great public health concern. To assess the seriousness of this problem, we quantified the amount of active ingredient present in artesunate tablets by liquid chromatography coupled to mass spectrometry. This method, in conjunction with analysis of the packaging, classified tablets as genuine, substandard, or fake and validated results of the colorimetric Fast Red TR test. Eight (35%) of 23 fake artesunate samples contained the wrong active ingredients, which were identified as different erythromycins and paracetamol. Raman spectroscopy identified calcium carbonate as an excipient in 9 (39%) of 23 fake samples. Multivariate unsupervised pattern recognition results indicated two major clusters of artesunate counterfeits, those with counterfeit foil stickers and containing calcium carbonate, erythromycin, and paracetamol, and those with counterfeit holograms and containing starch but without evidence of erythromycin or paracetamol.
Author Notes
ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
-
1
WHO, 1999. Counterfeit Drugs. Guidelines for the Development of Measures to Combat Counterfeit Drugs. Available from http://www.who.int/medicines/publications/counterfeitguidelines/en/.
-
2
O’Brien KL, Selanikio JD, Hecdivert C, Placide MF, Louis M, Barr DB, Barr JR, Hospedales CJ, Lewis MJ, Schwartz B, Philen RM, St Victor S, Espindola J, Needham LL, Denerville K, 1998. Epidemic of pediatric deaths from acute renal failure caused by diethylene glycol poisoning. JAMA 279 :1175–1180.
-
3
Hanif M, Mobarak MR, Ronan A, Rahman D, Donovan JJ, Bennish ML, 1995. Fatal renal-failure caused by diethylene glycol in paracetamol elixir: the Bangladesh epidemic. BMJ 311 :88–91.
-
4
Newton PN, White NJ, Rozendaal JA, Green MD, 2002. Murder by fake drugs: time for international action. BMJ 324 :800–801.
-
5
Cockburn R, Newton PN, Agyarko EK, Akunyili D, White NJ, 2005. The global threat of counterfeit drugs: why industry and governments must communicate the dangers. PLoS Med 2 :100–106.
-
6
Newton P, Proux S, Green M, Smithuis F, Rozendaal J, Prakongpan S, Chotivanich K, Mayxay M, Looareesuwan S, Farrar J, Nosten F, White NJ, 2001. Fake artesunate in southeast Asia. Lancet 357 :1948–1950.
-
7
Newton PN, Green M, Fernandez FM, Day NP, White NJ, 2006. Counterfeit anti-infective drugs. Lancet Infect Dis. 6 :602–613.
-
8
Basco LK, 2004. Molecular epidemiology of malaria in Cameroon. XIX. Quality of antimalarial drugs used for self-medication. Am J Trop Med Hyg 70 :245–250.
-
9
Daviss B, 2005. Malaria, science, and social responsibility. Scientist 19 :42–43.
-
10
White NJ, 2004. Antimalarial drug resistance. J Clin Invest 113 :1084–1092.
-
11
van Agtmael MA, Eggelte TA, van Boxtel CJ, 1999. Artemisinin drugs in the treatment of malaria: From medicinal herb to registered medication. Trends Pharmacol Sci 20 :199–205.
-
12
Aldhous P, 2005. Murder by medicine. Nature 434 :132–136.
-
13
Dondorp AM, Newton PN, Mayxay M, van Damme W, Smithuis FM, Yeung S, Petit A, Lynam AJ, Johnson A, Hien TT, McGready R, Farrar JJ, Looareesuwan S, Day NPJ, Green MD, White NJ, 2004. Fake antimalarials in southeast Asia are a major impediment to malaria control: multinational cross-sectional survey on the prevalence of fake antimalarials. Trop Med Int Health 9 :1241–1246.
-
14
Newton PN, Dondorp A, Green M, Mayxay M, White NJ, 2003. Counterfeit artesunate antimalarials in southeast Asia. Lancet 362 :169.
-
15
Newton PN, McGready R, Fernandez FM, Green MD, Sunjio M, Bruneton C, Phanouvong S, Millet P, Whitty CJ, Talisuna AO, Proux S, Christophel EM, Malenga G, Singhasivanon P, Bojang K, Kaur H, Palmer K, Day NPJ, Greenwood BM, Nosten F, White NJ, 2006. Manslaughter by fake artesunate in Asia: will Africa be next? PLoS Med 3 :1–4.
-
16
Green M, Mount DL, Wirtz RA, 2001. Authentication of Artemether, Artesunate and dihydroartemisin antimalarial tablets using a simple colorimetric method. Trop Med Int Health 6 :980–982.
-
17
Lim CK, Lord G, 2002. Current developments in LC-MS for pharmaceutical analysis. Biol Pharm Bull 25 :547–557.
-
18
NIST Scientific and Technical Databases, 2002. Available from http://www.nist.gov/srd/nist1a.htm.
-
19
Vankeirsbilck T, Vercauteren A, Baeyens W, Van der Weken G, Verpoort F, Vergote G, Remon JP, 2002. Applications of Raman spectroscopy in pharmaceutical analysis. TrAC Trends Anal Chem 21 :869–877.
-
20
Massart DL, Vandeginste BG, Buydens LM, De Jong S, Lewi PJ, Smeyers-Verbeke J, 1997. Handbook of Chemometrics and Qualimetrics. Amsterdam: Elsevier.
-
21
World Health Organization, 2006. What Are Substandard Drugs? Available from http://www.who.int/medicines/services/counterfeit/faqs/06/en/.
-
22
Gates P, Kearney G, Jones R, Leadlay P, Staunton J, 1999. Structural elucidation studies of erythromycins by electrospray tandem mass spectrometry. Rapid Commun Mass Spectrom 13 :242–246.
-
23
Wardrop J, Ficker D, Franklin S, Gorski R, 2000. Determination of erythromycin and related substances in enteric-coated tablet formulations by reversed-phase liquid chromatography. J Pharm Sci 89 :1097–1105.
-
24
Allen LV Jr, Popovich NG, Ansel HC, Allen LV, 2004. Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems. Philadelphia: Lippincott Williams and Wilkins.
-
25
Jähnke RW, Küsters G, 2001. Detecting counterfeit drugs-protection against counterfeit medicines using the GPHF-Minilab. Bull Mekong Malaria Forum 8 :118–124.
-
26
Rozendaal J, 2000. Fake antimalarials circulating in Cambodia. Bull Mekong Malaria Forum 7 :62–68.
-
27
United States Pharmacopeia, 2006. Fake Malarials Found in Yunnan Province, China. Available from http://www.uspdqi.org/pubs/other/FakeAntimalarialsinChina.pdf.
-
28
Hartl DL, 2004. The origin of malaria: mixed messages from genetic diversity. Nat Rev Microbiol 2 :15–22.
-
29
Fernandez FM, Cody RB, Green M, Hampton CY, McGready R, Sengaloundeth S, White NJ, Newton PN, 2006. Characterization of solid counterfeit drug samples by desorption electro-spray ionization and direct-analysis-in-real-time coupled to time-of-flight mass spectrometry. Chem Med Chem 1 :702–705.
-
30
Wolff JC, Thomson LA, Eckers C, 2003. Identification of the ‘wrong’ active pharmaceutical ingredient in a counterfeit Hal-fan(TM) drug product using accurate mass electrospray ionisation mass spectrometry, accurate mass tandem mass spectrometry and liquid chromatography/mass spectrometry. Rapid Commun Mass Spectrom 17 :215–221.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 1143 | 1012 | 21 |
| Full Text Views | 399 | 6 | 0 |
| PDF Downloads | 137 | 9 | 0 |