Abstract

Counterfeit medicines represent a global public health threat warranting the development of accurate, rapid, and nondestructive methods for their identification. Portable near-infrared (NIR) spectroscopy offers this advantage. This work sheds light on the potential of combining NIR spectroscopy with principal component analysis (PCA) and soft independent modelling of class analogy (SIMCA) for authenticating branded and generic antibiotics. A total of 23 antibiotics were measured “nondestructively” using a portable NIR spectrometer. The antibiotics corresponded to six different active pharmaceutical ingredients being: amoxicillin trihydrate and clavulanic acid, azithromycin dihydrate, ciprofloxacin hydrochloride, doxycycline hydrochloride, and ofloxacin. NIR spectra were exported into Matlab R2018b where data analysis was applied. The results showed that the NIR spectra of the medicines showed characteristic features that corresponded to the main excipient(s). When combined with PCA, NIR spectroscopy could distinguish between branded and generic medicines and could classify medicines according to their manufacturing sources. The PCA scores showed the distinct clusters corresponding to each group of antibiotics, whereas the loadings indicated which spectral features were significant. SIMCA provided more accurate classification over PCA for all antibiotics except ciprofloxacin which products shared many overlapping excipients. In summary, the findings of the study demonstrated the feasibility of portable NIR as an initial method for screening antibiotics.

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2018 (2)

S. Schäfermann, E. Wemakor, C. Hauk, L. Heide. “Quality of Medicines in Southern Togo: Investigation of Antibiotics and of Medicines for Non-Communicable Diseases from Pharmacies and Informal Vendors”. PLoS One. 2018, 13(11): E0207911.

N. Tshilombo, P. Hamuli, J. Mbinze, V. Habyalimana, et al. “Investigation of the Quality of Antibiotics-Based Amoxicillin for Monitoring of Some Different Medicine Markets of Democratic Republic of Congo”. Am. J. Anal. Chem. 2018, 9(8): 366–385.

2017 (2)

F. Khuluza, S. Kigera, L. Heide. “Low Prevalence of Substandard and Falsified Antimalarial and Antibiotic Medicines in Public and Faith-Based Health Facilities of Southern Malawi”. Am. J. Trop. Med. Hyg. 2017, 96(5): 1124–1135.

H. Yang, B. Hu, X. Pan, S. Yan, et al. “Deep Belief Network-Based Drug Identification Using Near Infrared Spectroscopy”. J. Innov. Opt. Heal. Sci. 2017, 10(2): 1630011.

2015 (1)

I. Fadeyi, M. Lalani, N. Mailk, A. Van Wyk, H. Kaur. “Quality of the Antibiotics—Amoxicillin and Co-Trimoxazole from Ghana, Nigeria, and the United Kingdom”. Am. Soc. Trop. Med. Hyg. 2015, 92(6): 87–94.

2014 (4)

S. Bekoe, S. Bak, E. Björklund, K. Krogh, et al. “Determination of Thirteen Antibiotics in Drug Products: A New LC-MS/MS Tool for Screening Drug Product Quality”. Anal. Methods. 2014, 6(15): 5847–5855.

A. Pomerantsev, O. Rodionova. “Concept and Role of Extreme Objects in PCA/SIMCA”. J Chemom. 2014, 28(5): 429–438.

S. Kovacs, S. Hawes, S. Maley, E. Mosites, et al. “Technologies for Detecting Falsified and Substandard Drugs in Low and Middle-Income Countries”. PLoS One. 2014, 9(3): E90601.

O. Rodionova, K. Balyklova, A. Titova, A. Pomerantsev. “Quantitative Risk Assessment in Classification of Drugs with Identical API Content”. J. Pharm. Biomed. Anal. 2014, 98: 186–192.

2013 (1)

A. Weaver, H. Reiser, T. Barstis, M. Benvenuti, et al. “Paper Analytical Devices for Fast Field Screening of Beta Lactam Antibiotics and Antituberculosis Pharmaceuticals”. Anal. Chem. 2013, 85(13): 6453–6460.

2012 (2)

J. Mbinze, P. Lebrun, B. Debrus, A. Dispas, et al. “Application of an Innovative Design Space Optimization Strategy to the Development of Liquid Chromatographic Methods to Combat Potentially Counterfeit Nonsteroidal Anti-Inflammatory Drugs”. J. Chromatogr. A. 2012, 1263: 113–124.

A. Delepierre, A. Gayot, A. Carpentier. “Update On Counterfeit Antibiotics Worldwide; Public Health Risks”. Med. Maladies Infect. 2012, 42(6): 247–255.

2011 (1)

S. Assi, R. Watt, A. Moffat. “Identification of Counterfeit Medicines from the Internet and the World Market Using Near-Infrared Spectroscopy”. Anal. Methods. 2011, 3(10): 2231–2236.

2010 (1)

A. Moffat, S. Assi, R. Watt. “Identifying Counterfeit Medicines Using Near Infrared Spectroscopy”. J. Near Infrared Spectrosc. 2010, 18(1): 1–5.

2009 (1)

B. Singh, D. Parwate, S. Shukla. “Rapid Color Test Identification System for Screening of Counterfeit Fluoroquinolone”. J. Chem. 2009, 6(2): 377–384.

2008 (2)

S. Assi, R. Watt, A. Moffat. “Assay of Ciprofloxacin in Intact and Powdered Tablets by Near-Infrared Spectroscopy”. J. Pharm. Pharmacol. 2008, 60(S1): A7–A10.

T. Sakamoto, Y. Fujimaki, Y. Hiyama. “NIR Spectroscopic Investigation of Two Fluoroquinolones, Levofloxacin and Ofloxacin, and Their Tablets for Qualitative Identification of Commercial Products on the Market”. Die Pharmazie. 2008, 63(9): 628–632.

2007 (2)

A. Solangi, S. Memon, M. Khuhawar, M. Bhanger. “Quantitative Analysis of Eight Cephalosporin Antibiotics in Pharmaceutical Products and Urine by Capillary Zone Electrophoresis”. Acta Chromatogr. 2007, 19: 81–96.

T. Kelesidis, L. Kelesidis, P. Rafailidis, M. Falagas. “Counterfeit or Substandard Antimicrobial Drugs: A Review of the Scientific Evidence”. J. Antimicrob. Chemother. 2007, 60: 214–236.

2006 (1)

R. Brereton. “Consequences of Sample Size, Variable Selection, and Model Validation and Optimization, for Predicting Classification Ability from Analytical Data”. TrAC, Trends Anal. Chem. 2006, 25(11): 1103–1111.

2005 (1)

O. Rodionova, L. Houmøller, A. Pomerantsev, P. Geladi, et al. “NIR Spectrometry for Counterfeit Drug Detection: A Feasibility Study”. Anal. Chim. Acta. 2005, 549(1–2): 151–158.

2003 (1)

H. Frankish. “WHO Steps Up Campaign on Counterfeit Drugs”. Lancet. 2003, 362(9397): 1730.

2001 (2)

A. Po. “Too Much, Too Little, or None at All: Dealing with Substandard and Fake Drugs”. Lancet. 2001, 357(9272): 1904.

M. Issack. Substandard Drugs”. Lancet. 2001, 358(9291): 1463.

2000 (1)

J. Videau. “Generic Drugs: the Hidden Issues of Quality and Cost”. WHO Drug Information. 2000, 14(2): 77–81.

1997 (3)

L. Basco, P. Ringwald, A. Manéné, J. Chandenier. “False Chloroquine Resistance in Africa”. Lancet. 1997, 350(9072): 224.

O. Shakoor, R. Taylor, R. Behrens. “Assessment of the Incidence of Substandard Drugs in Developing Countries”. Trop. Med. Int. Health. 1997, 2(9): 839–845.

D. Menkes. Hazardous Drugs in Developing Countries: The Market May Be Healthier than the People.” Br. Med. J. 1997, 315(7122): 1557–1558.

Assi, S.

S. Assi, R. Watt, A. Moffat. “Identification of Counterfeit Medicines from the Internet and the World Market Using Near-Infrared Spectroscopy”. Anal. Methods. 2011, 3(10): 2231–2236.

A. Moffat, S. Assi, R. Watt. “Identifying Counterfeit Medicines Using Near Infrared Spectroscopy”. J. Near Infrared Spectrosc. 2010, 18(1): 1–5.

S. Assi, R. Watt, A. Moffat. “Assay of Ciprofloxacin in Intact and Powdered Tablets by Near-Infrared Spectroscopy”. J. Pharm. Pharmacol. 2008, 60(S1): A7–A10.

Bak, S.

S. Bekoe, S. Bak, E. Björklund, K. Krogh, et al. “Determination of Thirteen Antibiotics in Drug Products: A New LC-MS/MS Tool for Screening Drug Product Quality”. Anal. Methods. 2014, 6(15): 5847–5855.

Balyklova, K.

O. Rodionova, K. Balyklova, A. Titova, A. Pomerantsev. “Quantitative Risk Assessment in Classification of Drugs with Identical API Content”. J. Pharm. Biomed. Anal. 2014, 98: 186–192.

Barstis, T.

A. Weaver, H. Reiser, T. Barstis, M. Benvenuti, et al. “Paper Analytical Devices for Fast Field Screening of Beta Lactam Antibiotics and Antituberculosis Pharmaceuticals”. Anal. Chem. 2013, 85(13): 6453–6460.

Basco, L.

L. Basco, P. Ringwald, A. Manéné, J. Chandenier. “False Chloroquine Resistance in Africa”. Lancet. 1997, 350(9072): 224.

Behrens, R.

O. Shakoor, R. Taylor, R. Behrens. “Assessment of the Incidence of Substandard Drugs in Developing Countries”. Trop. Med. Int. Health. 1997, 2(9): 839–845.

Bekoe, S.

S. Bekoe, S. Bak, E. Björklund, K. Krogh, et al. “Determination of Thirteen Antibiotics in Drug Products: A New LC-MS/MS Tool for Screening Drug Product Quality”. Anal. Methods. 2014, 6(15): 5847–5855.

Benvenuti, M.

A. Weaver, H. Reiser, T. Barstis, M. Benvenuti, et al. “Paper Analytical Devices for Fast Field Screening of Beta Lactam Antibiotics and Antituberculosis Pharmaceuticals”. Anal. Chem. 2013, 85(13): 6453–6460.

Bhanger, M.

A. Solangi, S. Memon, M. Khuhawar, M. Bhanger. “Quantitative Analysis of Eight Cephalosporin Antibiotics in Pharmaceutical Products and Urine by Capillary Zone Electrophoresis”. Acta Chromatogr. 2007, 19: 81–96.

Björklund, E.

S. Bekoe, S. Bak, E. Björklund, K. Krogh, et al. “Determination of Thirteen Antibiotics in Drug Products: A New LC-MS/MS Tool for Screening Drug Product Quality”. Anal. Methods. 2014, 6(15): 5847–5855.

Brereton, R.

R. Brereton. “Consequences of Sample Size, Variable Selection, and Model Validation and Optimization, for Predicting Classification Ability from Analytical Data”. TrAC, Trends Anal. Chem. 2006, 25(11): 1103–1111.

Carpentier, A.

A. Delepierre, A. Gayot, A. Carpentier. “Update On Counterfeit Antibiotics Worldwide; Public Health Risks”. Med. Maladies Infect. 2012, 42(6): 247–255.

Chandenier, J.

L. Basco, P. Ringwald, A. Manéné, J. Chandenier. “False Chloroquine Resistance in Africa”. Lancet. 1997, 350(9072): 224.

Debrus, B.

J. Mbinze, P. Lebrun, B. Debrus, A. Dispas, et al. “Application of an Innovative Design Space Optimization Strategy to the Development of Liquid Chromatographic Methods to Combat Potentially Counterfeit Nonsteroidal Anti-Inflammatory Drugs”. J. Chromatogr. A. 2012, 1263: 113–124.

Delepierre, A.

A. Delepierre, A. Gayot, A. Carpentier. “Update On Counterfeit Antibiotics Worldwide; Public Health Risks”. Med. Maladies Infect. 2012, 42(6): 247–255.

Dispas, A.

J. Mbinze, P. Lebrun, B. Debrus, A. Dispas, et al. “Application of an Innovative Design Space Optimization Strategy to the Development of Liquid Chromatographic Methods to Combat Potentially Counterfeit Nonsteroidal Anti-Inflammatory Drugs”. J. Chromatogr. A. 2012, 1263: 113–124.

Fadeyi, I.

I. Fadeyi, M. Lalani, N. Mailk, A. Van Wyk, H. Kaur. “Quality of the Antibiotics—Amoxicillin and Co-Trimoxazole from Ghana, Nigeria, and the United Kingdom”. Am. Soc. Trop. Med. Hyg. 2015, 92(6): 87–94.

Falagas, M.

T. Kelesidis, L. Kelesidis, P. Rafailidis, M. Falagas. “Counterfeit or Substandard Antimicrobial Drugs: A Review of the Scientific Evidence”. J. Antimicrob. Chemother. 2007, 60: 214–236.

Filzmoser, P.

K. Varmuza, P. Filzmoser. Introduction to Multivariate Statistical Analysis in Chemometrics., Boca Raton, FL: CRC Press, 2016.

Frankish, H.

H. Frankish. “WHO Steps Up Campaign on Counterfeit Drugs”. Lancet. 2003, 362(9397): 1730.

Fujimaki, Y.

T. Sakamoto, Y. Fujimaki, Y. Hiyama. “NIR Spectroscopic Investigation of Two Fluoroquinolones, Levofloxacin and Ofloxacin, and Their Tablets for Qualitative Identification of Commercial Products on the Market”. Die Pharmazie. 2008, 63(9): 628–632.

Gayot, A.

A. Delepierre, A. Gayot, A. Carpentier. “Update On Counterfeit Antibiotics Worldwide; Public Health Risks”. Med. Maladies Infect. 2012, 42(6): 247–255.

Geladi, P.

O. Rodionova, L. Houmøller, A. Pomerantsev, P. Geladi, et al. “NIR Spectrometry for Counterfeit Drug Detection: A Feasibility Study”. Anal. Chim. Acta. 2005, 549(1–2): 151–158.

Habyalimana, V.

N. Tshilombo, P. Hamuli, J. Mbinze, V. Habyalimana, et al. “Investigation of the Quality of Antibiotics-Based Amoxicillin for Monitoring of Some Different Medicine Markets of Democratic Republic of Congo”. Am. J. Anal. Chem. 2018, 9(8): 366–385.

Hamuli, P.

N. Tshilombo, P. Hamuli, J. Mbinze, V. Habyalimana, et al. “Investigation of the Quality of Antibiotics-Based Amoxicillin for Monitoring of Some Different Medicine Markets of Democratic Republic of Congo”. Am. J. Anal. Chem. 2018, 9(8): 366–385.

Hauk, C.

S. Schäfermann, E. Wemakor, C. Hauk, L. Heide. “Quality of Medicines in Southern Togo: Investigation of Antibiotics and of Medicines for Non-Communicable Diseases from Pharmacies and Informal Vendors”. PLoS One. 2018, 13(11): E0207911.

Hawes, S.

S. Kovacs, S. Hawes, S. Maley, E. Mosites, et al. “Technologies for Detecting Falsified and Substandard Drugs in Low and Middle-Income Countries”. PLoS One. 2014, 9(3): E90601.

Heide, L.

S. Schäfermann, E. Wemakor, C. Hauk, L. Heide. “Quality of Medicines in Southern Togo: Investigation of Antibiotics and of Medicines for Non-Communicable Diseases from Pharmacies and Informal Vendors”. PLoS One. 2018, 13(11): E0207911.

F. Khuluza, S. Kigera, L. Heide. “Low Prevalence of Substandard and Falsified Antimalarial and Antibiotic Medicines in Public and Faith-Based Health Facilities of Southern Malawi”. Am. J. Trop. Med. Hyg. 2017, 96(5): 1124–1135.

Hiyama, Y.

T. Sakamoto, Y. Fujimaki, Y. Hiyama. “NIR Spectroscopic Investigation of Two Fluoroquinolones, Levofloxacin and Ofloxacin, and Their Tablets for Qualitative Identification of Commercial Products on the Market”. Die Pharmazie. 2008, 63(9): 628–632.

Houmøller, L.

O. Rodionova, L. Houmøller, A. Pomerantsev, P. Geladi, et al. “NIR Spectrometry for Counterfeit Drug Detection: A Feasibility Study”. Anal. Chim. Acta. 2005, 549(1–2): 151–158.

Hu, B.

H. Yang, B. Hu, X. Pan, S. Yan, et al. “Deep Belief Network-Based Drug Identification Using Near Infrared Spectroscopy”. J. Innov. Opt. Heal. Sci. 2017, 10(2): 1630011.

Issack, M.

M. Issack. Substandard Drugs”. Lancet. 2001, 358(9291): 1463.

Kaur, H.

I. Fadeyi, M. Lalani, N. Mailk, A. Van Wyk, H. Kaur. “Quality of the Antibiotics—Amoxicillin and Co-Trimoxazole from Ghana, Nigeria, and the United Kingdom”. Am. Soc. Trop. Med. Hyg. 2015, 92(6): 87–94.

Kelesidis, L.

T. Kelesidis, L. Kelesidis, P. Rafailidis, M. Falagas. “Counterfeit or Substandard Antimicrobial Drugs: A Review of the Scientific Evidence”. J. Antimicrob. Chemother. 2007, 60: 214–236.

Kelesidis, T.

T. Kelesidis, L. Kelesidis, P. Rafailidis, M. Falagas. “Counterfeit or Substandard Antimicrobial Drugs: A Review of the Scientific Evidence”. J. Antimicrob. Chemother. 2007, 60: 214–236.

Khuhawar, M.

A. Solangi, S. Memon, M. Khuhawar, M. Bhanger. “Quantitative Analysis of Eight Cephalosporin Antibiotics in Pharmaceutical Products and Urine by Capillary Zone Electrophoresis”. Acta Chromatogr. 2007, 19: 81–96.

Khuluza, F.

F. Khuluza, S. Kigera, L. Heide. “Low Prevalence of Substandard and Falsified Antimalarial and Antibiotic Medicines in Public and Faith-Based Health Facilities of Southern Malawi”. Am. J. Trop. Med. Hyg. 2017, 96(5): 1124–1135.

Kigera, S.

F. Khuluza, S. Kigera, L. Heide. “Low Prevalence of Substandard and Falsified Antimalarial and Antibiotic Medicines in Public and Faith-Based Health Facilities of Southern Malawi”. Am. J. Trop. Med. Hyg. 2017, 96(5): 1124–1135.

Kovacs, S.

S. Kovacs, S. Hawes, S. Maley, E. Mosites, et al. “Technologies for Detecting Falsified and Substandard Drugs in Low and Middle-Income Countries”. PLoS One. 2014, 9(3): E90601.

Krogh, K.

S. Bekoe, S. Bak, E. Björklund, K. Krogh, et al. “Determination of Thirteen Antibiotics in Drug Products: A New LC-MS/MS Tool for Screening Drug Product Quality”. Anal. Methods. 2014, 6(15): 5847–5855.

Lalani, M.

I. Fadeyi, M. Lalani, N. Mailk, A. Van Wyk, H. Kaur. “Quality of the Antibiotics—Amoxicillin and Co-Trimoxazole from Ghana, Nigeria, and the United Kingdom”. Am. Soc. Trop. Med. Hyg. 2015, 92(6): 87–94.

Lebrun, P.

J. Mbinze, P. Lebrun, B. Debrus, A. Dispas, et al. “Application of an Innovative Design Space Optimization Strategy to the Development of Liquid Chromatographic Methods to Combat Potentially Counterfeit Nonsteroidal Anti-Inflammatory Drugs”. J. Chromatogr. A. 2012, 1263: 113–124.

Mailk, N.

I. Fadeyi, M. Lalani, N. Mailk, A. Van Wyk, H. Kaur. “Quality of the Antibiotics—Amoxicillin and Co-Trimoxazole from Ghana, Nigeria, and the United Kingdom”. Am. Soc. Trop. Med. Hyg. 2015, 92(6): 87–94.

Maley, S.

S. Kovacs, S. Hawes, S. Maley, E. Mosites, et al. “Technologies for Detecting Falsified and Substandard Drugs in Low and Middle-Income Countries”. PLoS One. 2014, 9(3): E90601.

Manéné, A.

L. Basco, P. Ringwald, A. Manéné, J. Chandenier. “False Chloroquine Resistance in Africa”. Lancet. 1997, 350(9072): 224.

Mbinze, J.

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S. Assi, R. Watt, A. Moffat. “Assay of Ciprofloxacin in Intact and Powdered Tablets by Near-Infrared Spectroscopy”. J. Pharm. Pharmacol. 2008, 60(S1): A7–A10.

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S. Assi, R. Watt, A. Moffat. “Assay of Ciprofloxacin in Intact and Powdered Tablets by Near-Infrared Spectroscopy”. J. Pharm. Pharmacol. 2008, 60(S1): A7–A10.

Weaver, A.

A. Weaver, H. Reiser, T. Barstis, M. Benvenuti, et al. “Paper Analytical Devices for Fast Field Screening of Beta Lactam Antibiotics and Antituberculosis Pharmaceuticals”. Anal. Chem. 2013, 85(13): 6453–6460.

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S. Schäfermann, E. Wemakor, C. Hauk, L. Heide. “Quality of Medicines in Southern Togo: Investigation of Antibiotics and of Medicines for Non-Communicable Diseases from Pharmacies and Informal Vendors”. PLoS One. 2018, 13(11): E0207911.

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H. Yang, B. Hu, X. Pan, S. Yan, et al. “Deep Belief Network-Based Drug Identification Using Near Infrared Spectroscopy”. J. Innov. Opt. Heal. Sci. 2017, 10(2): 1630011.

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H. Yang, B. Hu, X. Pan, S. Yan, et al. “Deep Belief Network-Based Drug Identification Using Near Infrared Spectroscopy”. J. Innov. Opt. Heal. Sci. 2017, 10(2): 1630011.

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N. Tshilombo, P. Hamuli, J. Mbinze, V. Habyalimana, et al. “Investigation of the Quality of Antibiotics-Based Amoxicillin for Monitoring of Some Different Medicine Markets of Democratic Republic of Congo”. Am. J. Anal. Chem. 2018, 9(8): 366–385.

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A. Weaver, H. Reiser, T. Barstis, M. Benvenuti, et al. “Paper Analytical Devices for Fast Field Screening of Beta Lactam Antibiotics and Antituberculosis Pharmaceuticals”. Anal. Chem. 2013, 85(13): 6453–6460.

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A. Pomerantsev, O. Rodionova. “Concept and Role of Extreme Objects in PCA/SIMCA”. J Chemom. 2014, 28(5): 429–438.

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T. Kelesidis, L. Kelesidis, P. Rafailidis, M. Falagas. “Counterfeit or Substandard Antimicrobial Drugs: A Review of the Scientific Evidence”. J. Antimicrob. Chemother. 2007, 60: 214–236.

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B. Singh, D. Parwate, S. Shukla. “Rapid Color Test Identification System for Screening of Counterfeit Fluoroquinolone”. J. Chem. 2009, 6(2): 377–384.

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J. Mbinze, P. Lebrun, B. Debrus, A. Dispas, et al. “Application of an Innovative Design Space Optimization Strategy to the Development of Liquid Chromatographic Methods to Combat Potentially Counterfeit Nonsteroidal Anti-Inflammatory Drugs”. J. Chromatogr. A. 2012, 1263: 113–124.

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H. Yang, B. Hu, X. Pan, S. Yan, et al. “Deep Belief Network-Based Drug Identification Using Near Infrared Spectroscopy”. J. Innov. Opt. Heal. Sci. 2017, 10(2): 1630011.

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Supplementary Material (1)

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» Supplement 1       sj-pdf-1-asp-10.1177_0003702820958081 - Supplemental material for Authentication of Antibiotics Using Portable Near-Infrared Spectroscopy and Multivariate Data Analysis

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