Application of NIR handheld transmission spectroscopy and chemometrics to assess the quality of locally produced antimalarial medicines in the Democratic Republic of Congo
[en] In recent decades, more than 15% of the antimalarials marketed in low- and middle-income countries have been of poor quality, in which quinoline derivatives and quinine-based formulations account for 21%.
Near infrared spectroscopy (NIR) was chosen for its fast and inexpensive test properties as well as the ability of using handheld devices to monitor drugs directly on the field. Data driven - soft independent modelling of class analogy (DD-SIMCA) and partial least squares (PLS) regression models were developed for qualitative and quantitative purpose, respectively. The specificity and selectivity tests were performed using the DD-SIMCA models on the placebo, the quinidine and cinchonine standard samples. Then, PLS regression methods have been developed and validated for the quality control of quinine dosage forms manufactured by a major local manufacturer in the Democratic Republic of Congo (DRC).
Calibration and validation samples were prepared by dissolving quinine sulphate /quinine hydrochloride in the presence of excipients in HCl 1M. The opportunity to work with dissolved quinine with a cheap and readily available medium in low and middle income countries allowed analysis of different pharmaceutical forms (oral drops, solutions for injection and tablets) with the same regression model. DD-SIMCA models have demonstrated for both equipment perfect authentication of quinine and good discrimination of the two alkaloids close to quinine namely cinchonine and quinidine.
The NIR PLS regression models were successfully validated using the total error approach with acceptance limits set at ± 10% with a risk level of 5%. The predictive performance of the methods developed was tested in terms of robustness.
Research Center/Unit :
CIRM - Centre Interdisciplinaire de Recherche sur le Médicament - ULiège
Application of NIR handheld transmission spectroscopy and chemometrics to assess the quality of locally produced antimalarial medicines in the Democratic Republic of Congo
Publication date :
August 2021
Journal title :
Talanta Open
ISSN :
2666-8319
Publisher :
Elsevier
Volume :
3
Pages :
100025
Peer reviewed :
Peer Reviewed verified by ORBi
Funders :
ARES - Académie de Recherche et d'Enseignement Supérieur ARES CCD - Académie de Recherche et d'Enseignement Supérieur. Coopération au Développement DGTRE - Région wallonne. Direction générale des Technologies, de la Recherche et de l'Énergie FEDER - Fonds Européen de Développement Régional
scite shows how a scientific paper has been cited by providing the context of the citation, a classification describing whether it supports, mentions, or contrasts the cited claim, and a label indicating in which section the citation was made.
Bibliography
Bakeev, K.A., Process Analytical Technology (2010), Wiley, Blackwell Publishing Ltd Oxford, UK
Allison, G., Cain, Y.T., Cooney, C., Garcia, T., Bizjak, T.G., Holte, O., Jagota, N., Zezza, D., Regulatory and quality considerations for continuous manufacturing May 20–21, 2014 continuous manufacturing symposium (2015) J. Pharm. Sci., 104, pp. 803-812
US, F.D.A., Guidance For Industry Guidance For Industry PAT — A Framework For Innovative Pharmaceutical (2004)
De Leersnyder, F., Vanhoorne, V., Kumar, A., Vervaet, C., De Beer, T., Evaluation of an in-line NIR spectroscopic method for the determination of the residence time in a tablet press (2019) Int. J. Pharm., 565, pp. 358-366
Igne, B., Airiau, C., Talwar, S., Towns, E., Chemometrics in the pharmaceutical industry (2020) Compr. Chemom., pp. 33-68. , 2nd Ed. Elsevier
Nagy, B., Petra, D., Galata, D.L., Démuth, B., Borbás, E., Marosi, G., Nagy, Z.K., Farkas, A., Application of artificial neural networks for process analytical technology-based dissolution testing (2019) Int. J. Pharm., 567
Lourenco, C., Orphanos, N., Parker, C., The international council for harmonisation: positioning for the future with its recent reform and over 25 years of harmonisation work (2016) Pharm. Policy Law., 18, pp. 79-89
(2018), http://www.who.int/news-room/fact-sheets/detail/substandard-and-falsified-medical-products, WHO, Substandard and falsified medical products - Fact Sheet
Brower, V., Falsified and substandard malaria drugs in Africa (2017) Lancet Infect. Dis., 17, pp. 1026-1027
Tie, Y., Vanhee, C., Deconinck, E., Adams, E., Development and validation of chromatographic methods for screening and subsequent quantification of suspected illegal antimicrobial drugs encountered on the Belgian market (2019) Talanta, 194, pp. 876-887
Mayer, J., (2002), Globalization, technology transfer and skill accumulation in low-income countries, in doi:10.4324/9780203427637.ch5
World Health Organization, (2011), Local production and access to medicines in low- and middle-income countries: a literature review and critical analysis
Praussello, F., Globalization and incomplete technology transfer to developing countries (2006) Glob. Third World, pp. 200-216. , Palgrave Macmillan UK, London
Ciza, P.H., Sacre, P.-Y., Waffo, C., Coïc, L., Avohou, H., Mbinze, J.K., Ngono, R., Ziemons, E., Comparing the qualitative performances of handheld NIR and Raman spectrophotometers for the detection of falsified pharmaceutical products (2019) Talanta, 202, pp. 469-478
Deidda, R., Sacre, P.-Y., Clavaud, M., Coïc, L., Avohou, H., Hubert, P., Ziemons, E., Vibrational spectroscopy in analysis of pharmaceuticals: critical review of innovative portable and handheld NIR and Raman spectrophotometers (2019) TrAC Trends Anal. Chem., 114, pp. 251-259
Vickers, S., Bernier, M., Zambrzycki, S., Fernandez, F.M., Newton, P.N., Caillet, C., Field detection devices for screening the quality of medicines: a systematic review (2018) BMJ Glob. Heal., 3
Rasheed, H., Höllein, L., Holzgrabe, U., Future information technology tools for fighting substandard and falsified medicines in low- and middle-income countries (2018) Front. Pharmacol., 9, p. 995
Fuenffinger, N., Arzhantsev, S., Gryniewicz-Ruzicka, C., Classification of ciprofloxacin tablets using near-infrared spectroscopy and chemometric modeling (2017) Appl. Spectrosc., 0
Zou, W.-B., Yin, L.-H., Jin, S.-H., Advances in rapid drug detection technology (2018) J. Pharm. Biomed. Anal., 147, pp. 81-88
Griffen, J.A., Owen, A.W., Burley, J., Taresco, V., Matousek, P., Rapid quantification of low level polymorph content in a solid dose form using transmission Raman spectroscopy (2016) J. Pharm. Biomed. Anal., 128, pp. 35-45
Pedersen, T., Rantanen, J., Naelapää, K., Skibsted, E., Near infrared analysis of pharmaceutical powders with empirical target distribution optimization (ETDO) (2020) J. Pharm. Biomed. Anal., 181
Hattori, Y., Sugata, M., Kamata, H., Nagata, M., Nagato, T., Hasegawa, K., Otsuka, M., Real-time monitoring of the tablet-coating process by near-infrared spectroscopy - effects of coating polymer concentrations on pharmaceutical properties of tablets (2018) J. Drug Deliv. Sci. Technol., 46, pp. 111-121
Pasquini, C., Near infrared spectroscopy: a mature analytical technique with new perspectives – a review (2018) Anal. Chim. Acta., 1026, pp. 8-36
Coic, L., Sacré, P.-Y., Dispas, A., Dumont, E., Horne, J., De Bleye, C., Fillet, M., Ziemons, E., Evaluation of the analytical performances of two Raman handheld spectrophotometers for pharmaceutical solid dosage form quantitation (2020) Talanta, 214
Yan, H., Siesler, H.W., Quantitative analysis of a pharmaceutical formulation: performance comparison of different handheld near-infrared spectrometers (2018) J. Pharm. Biomed. Anal., 160, pp. 179-186
Chavan, R.B., Bhargavi, N., Lodagekar, A., Shastri, N.R., Near infra red spectroscopy: a tool for solid state characterization (2017) Drug Discov. Today., 22, pp. 1835-1843
Qin, J., Kim, M.S., Chao, K., Dhakal, S., Cho, B.-K., Lohumi, S., Mo, C., Huang, M., Advances in Raman spectroscopy and imaging techniques for quality and safety inspection of horticultural products (2019) Postharvest Biol. Technol., 149, pp. 101-117
Hennigan, M.C., Ryder, A.G., Quantitative polymorph contaminant analysis in tablets using Raman and near infra-red spectroscopies (2013) J. Pharm. Biomed. Anal., 72, pp. 163-171
Heinz, A., Savolainen, M., Rades, T., Strachan, C.J., Quantifying ternary mixtures of different solid-state forms of indomethacin by Raman and near-infrared spectroscopy (2007) Eur. J. Pharm. Sci., 32, pp. 182-192
McGoverin, C.M., Ho, L.C.H., Zeitler, J.A., Strachan, C.J., Gordon, K.C., Rades, T., Quantification of binary polymorphic mixtures of ranitidine hydrochloride using NIR spectroscopy (2006) Vib. Spectrosc., 41, pp. 225-231
Blanco, M., Peguero, A., Influence of physical factors on the accuracy of calibration models for NIR spectroscopy (2010) J. Pharm. Biomed. Anal., 52, pp. 59-65
Grech, J., Robertson, J., Thomas, J., Cooper, G., Naunton, M., Kelly, T., An empirical review of antimalarial quality field surveys: the importance of characterising outcomes (2018) J. Pharm. Biomed. Anal., 147, pp. 612-623
Beargie, S.M., Higgins, C.R., Evans, D.R., Laing, S.K., Erim, D., Ozawa, S., The economic impact of substandard and falsified antimalarial medications in Nigeria (2019) PLoS ONE, 14
Medical Product Alert N° 2/2017 (2017), WHO
Medical Product Alert N° 10/2019 (2019), WHO
Mbinze, J.K., Sacré, P.-Y., Yemoa, A., Mavar Tayey Mbay, J., Habyalimana, V., Kalenda, N., Hubert, P., Ziemons, E., Development, validation and comparison of NIR and Raman methods for the identification and assay of poor-quality oral quinine drops (2015) J. Pharm. Biomed. Anal., 111, pp. 21-27
Zontov, Y.V., Rodionova, O.Y., Kucheryavskiy, S.V., Pomerantsev, A.L., DD-SIMCA — A MATLAB GUI tool for data driven SIMCA approach (2017) Chemom. Intell. Lab. Syst., 167, pp. 23-28
De Bleye, C., Chavez, P.F., Mantanus, J., Marini, R., Hubert, P., Rozet, E., Ziemons, E., Critical review of near-infrared spectroscopic methods validations in pharmaceutical applications (2012) J. Pharm. Biomed. Anal., 69, pp. 125-132
Hubert, P., Nguyen-Huu, J.-J., Boulanger, B., Chapuzet, E., Chiap, P., Cohen, N., Compagnon, P.-A., Valat, L., Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal–Part I (2004) J. Pharm. Biomed. Anal., 36, pp. 579-586
Validation of a analytical procedures : text and methodology Q2(R1) (2005) Guidance, 1994, p. 17
(2015), Food and Drug Administration, Development and submission of near infrared analytical procedures guidance for industry
Guideline on the use of Near Infrared Spectroscopy (NIRS) by the pharmaceutical industry and the data requirements for new submissions and variations (2014) Guideline-EMEA/CHMP/CVMP/QWP/17760/2009, 44, pp. 1-28
Similar publications
Sorry the service is unavailable at the moment. Please try again later.
This website uses cookies to improve user experience. Read more
Save & Close
Accept all
Decline all
Show detailsHide details
Cookie declaration
About cookies
Strictly necessary
Performance
Strictly necessary cookies allow core website functionality such as user login and account management. The website cannot be used properly without strictly necessary cookies.
This cookie is used by Cookie-Script.com service to remember visitor cookie consent preferences. It is necessary for Cookie-Script.com cookie banner to work properly.
Performance cookies are used to see how visitors use the website, eg. analytics cookies. Those cookies cannot be used to directly identify a certain visitor.
Used to store the attribution information, the referrer initially used to visit the website
Cookies are small text files that are placed on your computer by websites that you visit. Websites use cookies to help users navigate efficiently and perform certain functions. Cookies that are required for the website to operate properly are allowed to be set without your permission. All other cookies need to be approved before they can be set in the browser.
You can change your consent to cookie usage at any time on our Privacy Policy page.