Contributions to the Bacteriology of Leprosy
I. The Diphtheroid in Leprosy
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-
1.
WHO , 2017. WHO Global Surveillance and Monitoring System for Substandard and Falsified Medical Products. Geneva, Switzerland: World Health Organization.
-
2.
Jude N, Clark A, Nguyen PP, 2018. The role of product quality. Bull World Health Organ 96: 135–137.
-
3.
Peyraud N et al., 2017. An epidemic of dystonic reactions in central Africa. Lancet Glob Health 5: e137–e138.
-
4.
Schneider M, Nam NHT, 2021. How pharmaceutical companies can prevent falsified medicine and vaccines from entering African markets. J Intellect Prop Law Pract 16: 907–915.
-
5.
Borse NN et al., 2021. Responding to the Surge of Substandard and Falsified Health Products Triggered by the Covid-19 Pandemic. Available at: https://www.usp.org/sites/default/files/usp/document/our-impact/covid-19/surge-of-substandard-and-falsified-health-products.pdf. Accessed January 30, 2022.
-
6.
Okereke M, Anukwu I, Solarin S, Ohuabunwa SM, 2021. Combatting substandard and counterfeit medicines in the Nigerian drug market: how industrial pharmacists can rise up to the challenge. Innov Pharm 12: 15.
-
7.
Rahman MS, Yoshida N, Tsuboi H, Karmoker JR, Kabir N, Schaefermann S, Akimoto Y, Bhuiyan MA, Reza MS, Kimura K, 2022. A comprehensive analysis of selected medicines collected from private drug outlets of Dhaka city, Bangladesh in a simple random survey. Sci Rep 12: 234.
-
8.
UNODC , 2020. Covid-19-related Trafficking of Medical Products as a Threat to Public Health. Vienna, Austria: United Nations Office of Drugs and Crime. Available at: http://www.unodc.org/documents/data-and-analysis/covid/COVID-19_research_brief_trafficking_medical_products.pdf. Accessed March 30, 2021.
-
9.
Steingrüber S, Gadanya M, 2021. Weak Links: How Corruption Affects the Quality and Integrity of Medical Products and Impacts on the Covid-19 Response. Available at: https://www.u4.no/publications/weak-links-how-corruption-affects-the-quality-and-integrity-of-medical-products-and-impacts-on-the-covid-19-response.pdf. Accessed January 20, 2022.
-
10.
Tchounga WCA, Sacre PY, Ciza P, Ngono R, Ziemons E, Hubert P, Marini RD, 2021. Composition analysis of falsified chloroquine phosphate samples seized during the COVID-19 pandemic. J Pharm Biomed Anal 194: 113761.
-
11.
Tshilumba PM, Amuri SB, Kaghowa ER, Mbikay DM, Impele AB, Duez P, Ndoumba JBK, 2015. Enquête sur la contrefaçon de quelques anti-infectieux administrés per os commercialisés dans la ville de Lubumbashi. Pan Afr Med J 22: 602–613.
-
12.
Schäfermann S et al., 2020. Substandard and falsified antibiotics and medicines against noncommunicable diseases in western Cameroon and northeastern Democratic Republic of Congo. Am J Trop Med Hyg 103: 894–908.
-
13.
Mufusama JP, Ioset KN, Feineis D, Hoellein L, Holzgrabe U, Bringmann G, 2018. Quality of the antimalarial medicine artemether – lumefantrine in 8 cities of the Democratic Republic of the Congo. Drug Test Anal 10: 1599–1606.
-
14.
Abena PM et al., 2020. Chloroquine and hydroxychloroquine for the prevention or treatment of COVID-19 in Africa: caution for inappropriate off-label use in healthcare settings. Am J Trop Med Hyg 102: 1184–1188.
-
15.
Kelesidis T, Falagas ME, 2015. Substandard/counterfeit antimicrobial drugs. Clin Microbiol Rev 28: 443–464.
-
16.
Tie Y, Vanhee C, Deconinck E, Adams E, 2019. Development and validation of chromatographic methods for screening and subsequent quantification of suspected illegal antimicrobial drugs encountered on the Belgian market. Talanta 194: 876–887.
-
17.
Bakker-’t Hart IME, Ohana D, Venhuis BJ, 2021. Current challenges in the detection and analysis of falsified medicines. J Pharm Biomed Anal 197: 113948.
-
18.
Roth L, Nalim A, Turesson B, Krech L, 2018. Global landscape assessment of screening technologies for medicine quality assurance: stakeholder perceptions and practices from ten countries. Global Health 14: 43.
-
19.
Brits M, 2014. Combating unsafe medical products: outcomes of a survey on testing of suspect medicines. WHO Drug Inf 28: 317–323.
-
20.
Tshilumba PM et al., 2019. Substandard/falsification antibacterial agents: a systematic review of liquid chromatographic and spectrophotometric methods for their detection. Am J Anal Chem 10: 348–365.
-
21.
Hubert P et al., 2004. Harmonization of strategies for the validation of quantitative analytical procedures: a SFSTP proposal – part I. J Pharm Biomed Anal 36: 579–586.
-
22.
Stefanini-Oresic L, 2022. Validation of analytical procedures: ICH guidelines Q2(R2). Farm Glas2: 1–34.
-
23.
Kasongo MP, Mukoko KG, Kipata ML, Lunda IJ-M, 2018. Elaboration de la carte géotechnique de la ville de Lubumbashi guide technique de sélection des sites d’implantation d’ouvrages du génie civil. Eur Sci J 85: 83–92.
-
24.
ACTWATCH , 2017. Enquête sur les points de vente d’antipaludiques, République Démocratique du Congo, Kinshasa et Katanga. Available at: http://www.actwatch.info/sites/default/files/content/publications/attachments/DRC_2015%20OS_Brief_French.pdf. Accessed April 14, 2019.
-
25.
Benner A, Machin D, Campbell MJ, Fayers PM, Alain PY, Blackwell P, 1999. Sample size tables for clinical studies. Stat Med 41: 494–495.
-
26.
Mbinze JK, Dispas A, Lebrun P, Mbay JMT, Habyalimana V, Kalenda N, Rozet E, Hubert P, Marini RD, 2013. Application of an innovative design space optimization strategy to the development of LC methods for the simultaneous screening of antibiotics to combat poor quality medicines. J Pharm Biomed Anal 85: 83–92.
-
27.
European Pharmacopoeia , 2018. Pharmacotechnical Trials. Version 10.0 Chap II. 9.40. Available at: https://www.edqm.eu/en/newsroom-pheur. Accessed June 5, 2023.
-
28.
United State Pharmacopeia , 2020. USP-NF Online Login. Available at: http://www.uspnf.com/uspnf/login. Accessed June 20, 2018.
-
29.
Shah N, Sattigeri B, Patel N, Desai H, 2015. Counterfeit drugs in India: significance and impact on pharmacovigilance. Int J Res Med Sci 2015: 2156–2160.
-
30.
Hubert P et al., 2008. Harmonization of strategies for the validation of quantitative analytical procedures: a SFSTP proposal. Part IV. Examples of application. J Pharm Biomed Anal 48: 760–771.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 1795 | 488 | 81 |
| Full Text Views | 436 | 56 | 0 |
| PDF Downloads | 132 | 34 | 0 |
Detection of Substandard and Falsified Antibiotics Sold in the Democratic Republic of the Congo Using Validated HPLC and UV-Visible Spectrophotometric Methods
Pierrot Mwamba Tshilumba
Pierrot Mwamba Tshilumba
Department of Drug Analysis and Galenic, LAMEDA, University of Lubumbashi (UNILU), Lubumbashi, Democratic Republic of the Congo;
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Ange B. Ilangala
Ange B. Ilangala
Laboratory of Pharmaceutics and Phytopharmaceutical Drug Development, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa, Democratic Republic of the Congo;
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Jeremie Mbinze Kindenge
Jeremie Mbinze Kindenge
Laboratory of Pharmaceutics and Phytopharmaceutical Drug Development, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa, Democratic Republic of the Congo;
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Isaac Mutshitshi Kasongo
Isaac Mutshitshi Kasongo
Department of Drug Analysis and Galenic, LAMEDA, University of Lubumbashi (UNILU), Lubumbashi, Democratic Republic of the Congo;
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Guelord Kikunda
Guelord Kikunda
Department of Drug Analysis and Galenic, LAMEDA, University of Lubumbashi (UNILU), Lubumbashi, Democratic Republic of the Congo;
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Elie Rongorongo
Elie Rongorongo
Department of Drug Analysis and Galenic, LAMEDA, University of Lubumbashi (UNILU), Lubumbashi, Democratic Republic of the Congo;
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Alex Bokanya Impele
Alex Bokanya Impele
Department of Drug Analysis and Galenic, LAMEDA, University of Lubumbashi (UNILU), Lubumbashi, Democratic Republic of the Congo;
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Roland Marini Djang’eing’a
Roland Marini Djang’eing’a
Department of Pharmacy, Laboratory of Pharmaceutical Analytical Chemistry, University of Liege (ULiège), CIRM, VibraSante Hub, Liege, Belgium;
Faculty of Medicine and Pharmacy, University of Kisangani, Kisangani, Democratic Republic of the Congo
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Faculty of Medicine and Pharmacy, University of Kisangani, Kisangani, Democratic Republic of the Congo
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Jean-Baptiste Kalonji Ndoumba
Jean-Baptiste Kalonji Ndoumba
Department of Drug Analysis and Galenic, LAMEDA, University of Lubumbashi (UNILU), Lubumbashi, Democratic Republic of the Congo;
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ABSTRACT.
The access to afford safe, effective, and genuine medications is a major challenge for people in low- to middle-income countries. This study aimed at developing and validating simple, accurate, and inexpensive analytical liquid chromatography and ultraviolet-visible spectrophotometric methods to ensure quality control of antibiotics sold in formal and informal pharmaceutical markets. It focused on four antibiotics (azithromycin [AZT], cefadroxil [CFD], cefixime [CFX], and erythromycin [ERH]) used to treat infectious diseases in the region of Haut-Katanga in the Democratic Republic of the Congo (DRC). The total error strategy (accuracy profile) matching with the validation requirements of International Council on Harmonization was used for the validation. The validation results showed that three analytical methods of AZT, CFD, and ERH were validated according to the accuracy profile obtained, whereas the proposed method of CFX was not validated. Therefore, the United State Pharmacopoeia method permitted to quantify CFX samples. The dosage intervals ranged from 25 to 75 µg/mL for CFD, from 750 to 1,500 µg/mL for AZT, and from 500 to 750 µg/mL for ERH. The application of the validated method to samples collected (N = 95) allowed the detection of 25% substandard antibiotics with a rate of poor quality much higher in the informal circuit compared with the formal one (54% versus 11%; P < 0.05). The routine application of these methods will strengthen the quality control of drugs marketed in DRC. This study gives evidence for the availability of poor-quality antibiotics in the country, requiring the immediate attention of the national medicine regulatory authority.
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Author Notes
Authors’ addresses: Pierrot Mwamba Tshilumba, Isaac Mutshitshi Kasongo, Guelord Kikunda, Elie Rongorongo, Alex Bokanya Impele, and Jean-Baptiste Kalonji Ndoumba, Department of Drug Analysis and Galenic, LAMEDA, University of Lubumbashi (UNILU), Lubumbashi, Democratic Republic of the Congo, E-mails: tshilumbam@unilu.ac.cd, kasongoI@unilu.ac.cd, guelordkikunda@gmail.com, sirelierongo2@gmail.com, alexbokanya@gmail.com, and kalonji.ndoumba@unilu.ac.cd. Ange B. Ilangala and Jeremie Mbinze Kindenge, Laboratory of Pharmaceutics and Phytopharmaceutical Drug Development, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa, Democratic Republic of the Congo, E-mails: angeilangala14@gmail.com and jeremiembinze@gmail.com. Roland Marini Djang’eing’a, Department of Pharmacy, Laboratory of Pharmaceutical Analytical Chemistry, University of Liege (ULiège), CIRM, VibraSante Hub, Liege, Belgium, and Faculty of Medicine and Pharmacy, University of Kisangani, Kisangani, Democratic Republic of the Congo, E-mail: rmarini@uliege.be.
ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
-
1.
WHO , 2017. WHO Global Surveillance and Monitoring System for Substandard and Falsified Medical Products. Geneva, Switzerland: World Health Organization.
-
2.
Jude N, Clark A, Nguyen PP, 2018. The role of product quality. Bull World Health Organ 96: 135–137.
-
3.
Peyraud N et al., 2017. An epidemic of dystonic reactions in central Africa. Lancet Glob Health 5: e137–e138.
-
4.
Schneider M, Nam NHT, 2021. How pharmaceutical companies can prevent falsified medicine and vaccines from entering African markets. J Intellect Prop Law Pract 16: 907–915.
-
5.
Borse NN et al., 2021. Responding to the Surge of Substandard and Falsified Health Products Triggered by the Covid-19 Pandemic. Available at: https://www.usp.org/sites/default/files/usp/document/our-impact/covid-19/surge-of-substandard-and-falsified-health-products.pdf. Accessed January 30, 2022.
-
6.
Okereke M, Anukwu I, Solarin S, Ohuabunwa SM, 2021. Combatting substandard and counterfeit medicines in the Nigerian drug market: how industrial pharmacists can rise up to the challenge. Innov Pharm 12: 15.
-
7.
Rahman MS, Yoshida N, Tsuboi H, Karmoker JR, Kabir N, Schaefermann S, Akimoto Y, Bhuiyan MA, Reza MS, Kimura K, 2022. A comprehensive analysis of selected medicines collected from private drug outlets of Dhaka city, Bangladesh in a simple random survey. Sci Rep 12: 234.
-
8.
UNODC , 2020. Covid-19-related Trafficking of Medical Products as a Threat to Public Health. Vienna, Austria: United Nations Office of Drugs and Crime. Available at: http://www.unodc.org/documents/data-and-analysis/covid/COVID-19_research_brief_trafficking_medical_products.pdf. Accessed March 30, 2021.
-
9.
Steingrüber S, Gadanya M, 2021. Weak Links: How Corruption Affects the Quality and Integrity of Medical Products and Impacts on the Covid-19 Response. Available at: https://www.u4.no/publications/weak-links-how-corruption-affects-the-quality-and-integrity-of-medical-products-and-impacts-on-the-covid-19-response.pdf. Accessed January 20, 2022.
-
10.
Tchounga WCA, Sacre PY, Ciza P, Ngono R, Ziemons E, Hubert P, Marini RD, 2021. Composition analysis of falsified chloroquine phosphate samples seized during the COVID-19 pandemic. J Pharm Biomed Anal 194: 113761.
-
11.
Tshilumba PM, Amuri SB, Kaghowa ER, Mbikay DM, Impele AB, Duez P, Ndoumba JBK, 2015. Enquête sur la contrefaçon de quelques anti-infectieux administrés per os commercialisés dans la ville de Lubumbashi. Pan Afr Med J 22: 602–613.
-
12.
Schäfermann S et al., 2020. Substandard and falsified antibiotics and medicines against noncommunicable diseases in western Cameroon and northeastern Democratic Republic of Congo. Am J Trop Med Hyg 103: 894–908.
-
13.
Mufusama JP, Ioset KN, Feineis D, Hoellein L, Holzgrabe U, Bringmann G, 2018. Quality of the antimalarial medicine artemether – lumefantrine in 8 cities of the Democratic Republic of the Congo. Drug Test Anal 10: 1599–1606.
-
14.
Abena PM et al., 2020. Chloroquine and hydroxychloroquine for the prevention or treatment of COVID-19 in Africa: caution for inappropriate off-label use in healthcare settings. Am J Trop Med Hyg 102: 1184–1188.
-
15.
Kelesidis T, Falagas ME, 2015. Substandard/counterfeit antimicrobial drugs. Clin Microbiol Rev 28: 443–464.
-
16.
Tie Y, Vanhee C, Deconinck E, Adams E, 2019. Development and validation of chromatographic methods for screening and subsequent quantification of suspected illegal antimicrobial drugs encountered on the Belgian market. Talanta 194: 876–887.
-
17.
Bakker-’t Hart IME, Ohana D, Venhuis BJ, 2021. Current challenges in the detection and analysis of falsified medicines. J Pharm Biomed Anal 197: 113948.
-
18.
Roth L, Nalim A, Turesson B, Krech L, 2018. Global landscape assessment of screening technologies for medicine quality assurance: stakeholder perceptions and practices from ten countries. Global Health 14: 43.
-
19.
Brits M, 2014. Combating unsafe medical products: outcomes of a survey on testing of suspect medicines. WHO Drug Inf 28: 317–323.
-
20.
Tshilumba PM et al., 2019. Substandard/falsification antibacterial agents: a systematic review of liquid chromatographic and spectrophotometric methods for their detection. Am J Anal Chem 10: 348–365.
-
21.
Hubert P et al., 2004. Harmonization of strategies for the validation of quantitative analytical procedures: a SFSTP proposal – part I. J Pharm Biomed Anal 36: 579–586.
-
22.
Stefanini-Oresic L, 2022. Validation of analytical procedures: ICH guidelines Q2(R2). Farm Glas2: 1–34.
-
23.
Kasongo MP, Mukoko KG, Kipata ML, Lunda IJ-M, 2018. Elaboration de la carte géotechnique de la ville de Lubumbashi guide technique de sélection des sites d’implantation d’ouvrages du génie civil. Eur Sci J 85: 83–92.
-
24.
ACTWATCH , 2017. Enquête sur les points de vente d’antipaludiques, République Démocratique du Congo, Kinshasa et Katanga. Available at: http://www.actwatch.info/sites/default/files/content/publications/attachments/DRC_2015%20OS_Brief_French.pdf. Accessed April 14, 2019.
-
25.
Benner A, Machin D, Campbell MJ, Fayers PM, Alain PY, Blackwell P, 1999. Sample size tables for clinical studies. Stat Med 41: 494–495.
-
26.
Mbinze JK, Dispas A, Lebrun P, Mbay JMT, Habyalimana V, Kalenda N, Rozet E, Hubert P, Marini RD, 2013. Application of an innovative design space optimization strategy to the development of LC methods for the simultaneous screening of antibiotics to combat poor quality medicines. J Pharm Biomed Anal 85: 83–92.
-
27.
European Pharmacopoeia , 2018. Pharmacotechnical Trials. Version 10.0 Chap II. 9.40. Available at: https://www.edqm.eu/en/newsroom-pheur. Accessed June 5, 2023.
-
28.
United State Pharmacopeia , 2020. USP-NF Online Login. Available at: http://www.uspnf.com/uspnf/login. Accessed June 20, 2018.
-
29.
Shah N, Sattigeri B, Patel N, Desai H, 2015. Counterfeit drugs in India: significance and impact on pharmacovigilance. Int J Res Med Sci 2015: 2156–2160.
-
30.
Hubert P et al., 2008. Harmonization of strategies for the validation of quantitative analytical procedures: a SFSTP proposal. Part IV. Examples of application. J Pharm Biomed Anal 48: 760–771.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 1795 | 488 | 81 |
| Full Text Views | 436 | 56 | 0 |
| PDF Downloads | 132 | 34 | 0 |