Evaluation of Near-Infrared Chemical Imaging (NIR-CI) for the Authentication of Antibiotics
Abstract
Abstract Views: 544
Counterfeit medicines represent a public health threat that results in treatment failure and may even have lethal effects in the worst-case scenario. Near-infrared Chemical Imaging (NIR-CI) offers an informative and in-depth tool for several applications in the pharmaceutical industry, particularly for medicine authentication. The current study aimed to authenticate antibiotic tablets using NIR-CI. These tablets were measured non-destructively using a near-infrared microscope within their blister packaging, without their blisters, sectioned and crushed. The results showed that there was no marked difference in measuring the tablets within or without their blister packaging. The mean spectra of tablets showed high correlation coefficient values against the active pharmaceutical ingredient, in case of authentic tablets. On the other hand, counterfeit tablets showed key differences from their authentic alternatives with low correlation coefficient values. More specifically, counterfeit tablets showed poor distribution of the active pharmaceutical ingredient and excipients. It has been proved from the results that NIR-CI process is an authentic process for the evaluation of counterfeit tablets, non-destructively.
Downloads
References
World Health Organization. 1 in 10 medical products in developing countries is substandard or falsified. WHO Web site. https://www.who.int/news/item/28-11-2017-1-in-10-medical-products-in-developing-countries-is-substandard-or-falsified. Updated November 28, 2017. Accessed December 26, 2022.
Moffat AC, Assi S, Watt RA. Identifying counterfeit medicines using near-infrared spectroscopy. J Near Infrared Spectrosc. 2010;18(1):1–15.
World Health Organisation. Substandard and falsified medical products. WHO Web site. https://www.who.int/news-room/fact-sheets/detail/substandard-and-falsified-medical-products. Updated January 31, 2018. Accessed December 26, 2022.
Assi S, Watt RA, Moffat AC. Identification of counterfeit medicines from the internet and the world market using near-infrared spectroscopy. Anal Methods. 2010; 3:2231–2236. https://doi.org/10.1039/C1AY05227F
Wertheimer AI, Santella TM. Drug counterfeiting: The current situation and prevention strategies for the future. Int J Pharm Med. 2005;19:301–308. https://doi.org/10.2165/00124363-200519050-00007
World Health Organisation. Full list of WHO medical product alerts. WHO Web site. https://www.who.int/teams/regulation-prequalification/incidents-and-SF/full-list-of-who-medical-product-alerts. Updated January 11, 2023. Accessed January 25, 2023.
World Health Organisation. Medical product alert N°1/2023: Substandard (con-taminated) liquid dosage medicines. WHO Web site. https://www.who.int/news/item/11-01-2023-medical-product-alert-n-1-2023-substandard-(contaminated)-liquid-dosage-medicines. Updated January 11, 2023. Accessed January 25, 2023.
World Health Organisation. Medical product alert N°8/2022: Substandard (contaminated) METHOTREX 50mg. WHO Web site. https://www.who.int/news/item/27-12-2022-medical-product-alert-n-8-2022-substandard-(contaminated)-methotrex. Updated December 27, 2022. Accessed January 25, 2023.
World Health Organisation. Medical product alert N°7/2022: Substandard (contaminated) paediatric liquid dosage medicines. WHO Web site. https://www.who.int/news/item/02-11-2022-medical-product-alert-n-7-2022-substandard-(contaminated)-paediatric-liquid-dosage-medicines. Updated November 2, 2022. Accessed January 25, 2023.
World Health Organisation. Medical product alert N°6/2022: Substandard (contaminated) paediatric medicines. WHO web site. https://www.who.int/news/item/05-10-2022-medical-product-alert-n-6-2022-substandard-(contaminated)-paediatric-medicines. Updated October 5, 2022. Accessed January 25, 2023.
World Health Organisation. Medical product alert N°5/2022: DIPRIVAN. WHO Web site. https://www.who.int/news/item/25-08-2022-medical-product-alert-n-5-2022-falsified-diprivan. Updated August 25, 2022. Accessed January 25, 2023.
World Health Organisation. Medical product alert N°4/2022: Falsified DYSPORT. WHO Web site. https://www.who.int/news/item/19-08-2022-medical-product-alert-n-4-2022-falsified-dysport. Updated August 19, 2022. Accessed January 25, 2023.
World Health Organisation. Medical product alert N°3/2022: Falsified intratect (Human normal immunoglobulin). WHO Web site. https://www.who.int/news/item/27-05-2022-medical-product-alert-n-3-2022-falsified-intratect-human-normal-immunoglobulin. Updated May 27, 2022. Accessed January 25, 2023.
World Health Organisation. Medical product alert N°2/2022: Falsified DESREM (Remdesivir). WHO Web site. https://www.who.int/news/item/09-03-2022-medical-product-alert-n-2-2022-falsified-desrem-(remdesivir). Updated March 9, 2022. Accessed January 25, 2023.
Y Ozaki, K Awa, D Ishikawa. Near-infrared spectroscopy in biological molecules and tissues. In: Moffat AC, Osselton MD, Elliott SP, eds. Clarke's Analysis of Drugs and Poisons. London: Pharmaceutical Press; 2018.
Ravn C, Skibsted E, Bro R. Near-infrared chemical imaging (NIR-CI) on pharmaceutical solid dosage forms-comparing common calibration approaches. J Pharm Biomed Anal. 2008;48(3):554–561. https://doi.org/10.1016/j.jpba.2008.07.019
Li W, Woldu A, Kelly R, et al. Measurement of drug agglomerates in powder blending simulation samples by near infra-red chemical imaging. Int J Pharm. 2008;350(1-2):369–373. https://doi.org/10.1016/j.ijpharm.2007.08.055
Hilden L, Pommier CJ, Badawy S, Friedman EM. NIR chemical imaging to guide/ sup-port BMS-561389 tablet formulation development. Int J Pharm. 2008;353:283–290. https://doi.org/10.1016/j.ijpharm.2007.11.032
Shah RB, Tawakkul MA, Khan MA. Process analytical technology: Chemometric analysis of Raman and near infra-red spectroscopic data for predicting physical properties of ex-tended release matrix tablets. J Pharm Sci. 2007;96(5):1356–1365. https://doi.org/10.1002/jps.20931
Ellison CD, Ennis BJ, Hamad ML, Lyon RC. Measuring the distribution of density and tabletting force in pharmaceutical tablets by chemical imaging. J Pharm Biomed Anal. 2008;48(1):1–7. https://doi.org/10.1016/j.jpba.2008.04.020
Hammond SV, Clarke FC. Handbook of Vibrational Spectroscopy. London: John Wiley & Sons; 2002.
Clarke F. Extracting process-related information from pharmaceutical dosage forms using near infrared microscopy. Vib Spectrosc. 2004;34:25–35. https://doi.org/10.1016/j.vibspec.2003.08.005
Gendrin C, Roggo Y, Collet C. Pharmaceutical applications of vibrational chemical imaging and chemometrics: A review. J Pharm Biomed Anal. 2008;48(3):533–553. https://doi.org/10.1016/j.jpba.2008.08.014
Dubois J, Wolff JC, Warrack JK, Schoppelrei J, Lewis EN. NIR chemical imaging for counterfeit pharmaceutical products analysis. Spectrosc. 2007;22:40–50.
Westenberger BJ, Ellison CD, Fussner AS, et al. Quality assessment of internet pharmaceutical products using traditional and non-traditional analytical techniques. Int J Pharm. 2005;306(1-2):56–70. https://doi.org/10.1016/j.ijpharm.2005.08.027
Veronin MA, Lee E, Lewis EN. “Insight” into drug quality: Comparison of simvastatin tablets from the US and Canada obtained via the internet. Ann Pharmacother. 2007;41(7-8):1111–1115. https://doi.org/10.1345/aph.1H680
Veronin MA, Youan BBC. Magic bullet gone astray: Medications and the internet. Science. 2004;305(5683):481. https://doi.org/10.1126/science.1097355
Wolf JC, Warrack JK. NIR-based chemical imaging as an anticounterfeiting tool. Pharma Manufacturing. 2007:1–5.
Lopes MB, Wolff JC. Investigation into classification/ sourcing of suspect counterfeit Hep-todin tablets by near infrared chemical imaging. Anal Chim Acta. 2009; 633(1):149–155. https://doi.org/10.1016/j.aca.2008.11.036
Lopez MB, Wolf JC, Bioucas-Dias JM, Figueiredo MAT. Determination of the composition of counterfeit Heptodin tablets by near infrared chemical imaging and classical least square estimation. Anal Chim Acta. 2009;641(1-2):46–51. https://doi.org/10.1016/j.aca.2009.03.034
Sabin GP, Lozano VA, Rocha WFC, Romao W, Ortiz RS, Poppi RJ. Characterisation of sildenafil citrate tablets of different sources by near infrared chemical imaging and chemo-metric tools. J Pharm Biomed Anal. 2013;85:207–212. https://doi.org/10.1016/j.jpba.2013.07.036
Reich G. Near-infrared spectroscopy and imaging: Basic principles and pharmaceutical ap-plications. Adv Drug Delivery Rev. 2005;57(8):1109–1143. https://doi.org/10.1016/j.addr.2005.01.020
Amigo JM. Practical issues of hyperspectral imaging analysis of solid dosage forms. Anal and Bioanal Chem. 2010;398:93–109. https://doi.org/10.1007/s00216-010-3828-z
Puchert T, Lochmann D, Menezes JC, Reich G. Near-infrared chemical imaging (NIR-CI) for counterfeit drug identification—A four-stage concept with a novel approach of data pro-cessing (Linear Image Signature). J Pharm Biomed Anal. 2010;51(1):138–145. https://doi.org/10.1016/j.jpba.2009.08.022
Amigo JM, Cruz J, Bautista M, Maspoch S, Coello J, Blanco M. Study of pharmaceutical samples by NIR chemical-image and multivariate analysis. Trac-Trend Anal Chem. 2008;27(8):696–713. https://doi.org/10.1016/j.trac.2008.05.010
Amigo JM, Ravn C. Direct quantification and distribution assessment of major and minor components in pharmaceutical tablets by NIR-chemical imaging. J Pharm Sci. 2009;37(2):76–82. https://doi.org/10.1016/j.ejps.2009.01.001
Ravn C, Bro E. Near-infrared chemical imaging (NIR-CI) on pharmaceutical solid dosage forms—Comparing common calibration approaches. J Pharm Biomed Anal. 2010;48(3):554–561. https://doi.org/10.1016/j.jpba.2008.07.019
Cairos C, Amigo JM, Watt R, Coello J, Maspoch S. Implementation of enhanced correla-tion maps in near infrared chemical images: Application in pharmaceutical research. Talanta. 2009;79(3):657–664. https://doi.org/10.1016/j.talanta.2009.04.042
Malik I, Poonacha M, Moses J, Lodder RA. Multispectral imaging of tablets in blister packaging. AAPS PharmSciTech. 2001;2(2):1–7.
Hamilton SJ, Lowell AE, Lodder RA. Hyperspectral imaging technology for pharmaceutical analysis. J Biomedical Opt. 2002;7:561–570. https://doi.org/10.1117/12.472076
Jee RD. Near-infrared spectroscopy. In: Moffat AC, Osselton MD, Elliot SP, eds. Clarke's Analysis of Drugs and Poisons in Pharmaceutical Body Fluids Postmortem Material. Pharmaceutical Press; 2011.
Varmuza K, Filzmoser P. Introduction to Multivariate Statistical Analysis in Chemometrics. Boca Raton: Taylor & Francis Group; 2009.
Koehler FW, Lee E, Kidder LH, Lewis EN. Near infrared spectroscopy: The practical chemical imaging solution. Spectrosc Eur. 2002;14(3): 12–19.
Byarugaba DK. Antimicrobial resistance in developing countries and responsible risk factors. Int J Antimicrob Agents. 2004;24(2):105–110. https://doi.org/10.1016/j.ijantimicag.2004.02.015
Conley ZC, Bodine TJ, Chou A, Zechiedrich L. Wicked: The untold story of ciprofloxacin. PLoS Pathog. 2018;14(3):e1006805. https://doi.org/10.1371/journal.ppat.1006805
University of Oxford. Global antibiotic consumption rates increased by 46 percent since 2000. University of Oxford Web site. https://www.ox.ac.uk/news/2021-11-16-global-antibiotic-consumption-rates-increased-46-percent-2000. Updated November 16, 2021. Accessed January 26, 2023
Bhatti MW. Alarming threat: Probe launched after counterfeit medicines found in Hyderabad, Lahore. The News International. September 12, 2022. https://www.thenews.com.pk/print/990593-alarming-threat-probe-launched-after-counterfeit-medicines-found-in-hyderabad-lahore. Accessed January 26, 2023.
Taylor NP. Asia-Pacific roundup: Malaysia’s MDA posts draft guidance on custom-made medical devices. Regulatory Focus. November 1, 2022. https://www.raps.org/news-and-articles/news-articles/2022/11/asia-pacific-roundup-malaysias-mda-posts-draft-gui. Accessed January 26, 2023.
NAFDAC blacklists Indian company over fake ciprofloxacin. Premium Times. October 27, 2020. https://www.premiumtimesng.com/news/more-news/423277-nafdac-blacklists-indian-company-over-fake-ciprofloxacin.html. Accessed January 26, 2023.
Zabala GA, Bellingham K, Vidhamaly V, et al. Substandard and falsified antibiotics: Neglected drivers of antimicrobial resistance? BMJ Global Health. 2022;7(8):e008587. http://dx.doi.org/10.1136/bmjgh-2022-008587
Sharma D, Patel RP, Zaidi STR, Sarker MMR, Lean QY, Ming LC. Interplay of the quality of ciprofloxacin and antibiotic resistance in developing countries. Front Pharmacol. 2017;8:546. https://doi.org/10.3389/fphar.2017.00546
World Health Organisation. Antimicrobial resistance. WHO Web site. https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance. Updated November 17, 2021. Accessed January 26, 2023.
Shukla D. Antimicrobial resistance ‘is not an abstract threat lurking in the shadows’. Medical News Today. January 29, 2022. https://www.medicalnewstoday.com/articles/antimicrobial-resistance-is-not-an-abstract-threat-lurking-in-the-shadows. Accessed 26 January, 2023.
Zhang HL, Tan M, Qiu AM, Tao Z, Wang CH. Antibiotics for treatment of acute exacerbation of chronic obstructive pulmonary disease: A network meta-analysis. BMC Pulm Med. 2017;17(1):e196. https://doi.org/10.1186/s12890-017-0541-0
Clark F. NIR microscopy: Utilization from research through to full-scale manufacturing. Presented at: The European Conference on Near-infrared Spectroscopy; 2003; Heidelberg.
Rodionova OY, Houmoller LP, Pomerantsev P, et al. NIR spectrometry for counterfeit drug detection a feasibility study. Anal Chem Acta. 2005;549(1-2):151–158. https://doi.org/10.1016/j.aca.2005.06.018
Wu Z, Tao O, Cheng W, Yu L, Shi X, Qiao, Y. Visualizing excipient composition and homogeneity of Compound Liquorice tablets by near-infrared chemical imaging. Spectrochim Acta A. 2012;86:631–636. https://doi.org/10.1016/j.saa.2011.10.030
Khorasani M, Amigo JM, Sun CC, Bertelsen P, Rantanen J. Near-infrared chemical imaging (NIR-CI) as a process monitoring solution for a production line of roll compaction and tableting. Eur J Pharm Biopharm. 2015;93:293–302. https://doi.org/10.1016/j.ejpb.2015.04.008
Wahl PR, Pucher I, Scheibelhofer O, Kerschhaggl M, Sacher S, Khinast JG. Continuous monitoring of API content, API distribution and crushing strength after tableting via near-infrared chemical imaging. Int J Pharm. 2017;518(1-2):130–137. https://doi.org/10.1016/j.ijpharm.2016.12.003
Boldrini B, Kessler W, Rebner K, Kessler RW. Hyperspectral imaging: A review of best practice, performance and pitfalls for in-line and on-line applications. J Near Infrared Spectrosc. 2012;20(5):483–508.
Copyright (c) 2023 Sulaf Assi, Sarah Rowlands, Panos Liatsis, Mana Al Hamid, Jamila Mustafina, Maitham Ghaly Yousif, Thomas Coombs, Dhiya Al-Jumeily OBE
This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution (CC-BY) 4.0 License that allows others to share the work with an acknowledgement of the work’s authorship and initial publication in this journal
