Quality assessment of selected co-trimoxazole suspension brands marketed in Nairobi County, Kenya.

<h4>Introduction</h4>Quality of medicines in both developed and developing countries is sometimes compromised due to infiltration of counterfeit, substandard or degraded medicines into the markets. It is a public health concern as poor quality medicines endanger public health where patie...

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Autores principales: Beatrice Njeri Irungu, Lilian C Koech, Joyce M Ondicho, Lucia K Keter
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Publicado: Public Library of Science (PLoS) 2021
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spelling oai:doaj.org-article:fd0d18ef9fdf4274873b2e1956c096f42021-12-02T20:14:16ZQuality assessment of selected co-trimoxazole suspension brands marketed in Nairobi County, Kenya.1932-620310.1371/journal.pone.0257625https://doaj.org/article/fd0d18ef9fdf4274873b2e1956c096f42021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0257625https://doaj.org/toc/1932-6203<h4>Introduction</h4>Quality of medicines in both developed and developing countries is sometimes compromised due to infiltration of counterfeit, substandard or degraded medicines into the markets. It is a public health concern as poor quality medicines endanger public health where patients are exposed to chemical toxins and/or sub-therapeutic doses. This could lead to reduced treatment efficacy and promote development of drug resistance. Co-trimoxazole, a fixed dose combination of sulfamethoxazole and trimethoprim, is a broad spectrum for bacterial diseases and is also used as a prophylaxis for opportunistic infections in HIV infected individuals. This study evaluated quality of selected co-trimoxazole suspension brands marketed in Nairobi County, Kenya.<h4>Methods</h4>A total of 106 samples were collected, categorized into 15 brands and evaluated for active pharmaceutical ingredient content (API) and pH following United States Pharmacopeia. Assay for API was conducted using High Performance Liquid Chromatography. Results were compared with pharmacopeia references. Visual examination of labels and confirmation of retention status of the brands with Pharmacy and Poisons Board retention register was carried out.<h4>Results</h4>The samples were primarily of local origin (86.7%). On October 23, 2019, retention status of six of the fifteen brands documented were no longer listed in the Pharmacy and Poisons Board retention register. Of the 106 samples tested 70.6% and 86.8% were compliant with United States Pharmacopeia (USP) specifications for pH and API respectively while 84.0% adhered to packaging and labelling requirements.<h4>Conclusion</h4>This study has demonstrated that majority of co-trimoxazole suspensions tested were compliant with USP requirements. Additionally, it has provided evidence of poor quality co-trimoxazole medicines that could compromise treatment of infectious diseases in children. This emphasizes the need for regular quality assurance tests to ensure only quality medicines are in the market.Beatrice Njeri IrunguLilian C KoechJoyce M OndichoLucia K KeterPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 9, p e0257625 (2021)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle Medicine
R
Science
Q
Beatrice Njeri Irungu
Lilian C Koech
Joyce M Ondicho
Lucia K Keter
Quality assessment of selected co-trimoxazole suspension brands marketed in Nairobi County, Kenya.
description <h4>Introduction</h4>Quality of medicines in both developed and developing countries is sometimes compromised due to infiltration of counterfeit, substandard or degraded medicines into the markets. It is a public health concern as poor quality medicines endanger public health where patients are exposed to chemical toxins and/or sub-therapeutic doses. This could lead to reduced treatment efficacy and promote development of drug resistance. Co-trimoxazole, a fixed dose combination of sulfamethoxazole and trimethoprim, is a broad spectrum for bacterial diseases and is also used as a prophylaxis for opportunistic infections in HIV infected individuals. This study evaluated quality of selected co-trimoxazole suspension brands marketed in Nairobi County, Kenya.<h4>Methods</h4>A total of 106 samples were collected, categorized into 15 brands and evaluated for active pharmaceutical ingredient content (API) and pH following United States Pharmacopeia. Assay for API was conducted using High Performance Liquid Chromatography. Results were compared with pharmacopeia references. Visual examination of labels and confirmation of retention status of the brands with Pharmacy and Poisons Board retention register was carried out.<h4>Results</h4>The samples were primarily of local origin (86.7%). On October 23, 2019, retention status of six of the fifteen brands documented were no longer listed in the Pharmacy and Poisons Board retention register. Of the 106 samples tested 70.6% and 86.8% were compliant with United States Pharmacopeia (USP) specifications for pH and API respectively while 84.0% adhered to packaging and labelling requirements.<h4>Conclusion</h4>This study has demonstrated that majority of co-trimoxazole suspensions tested were compliant with USP requirements. Additionally, it has provided evidence of poor quality co-trimoxazole medicines that could compromise treatment of infectious diseases in children. This emphasizes the need for regular quality assurance tests to ensure only quality medicines are in the market.
format article
author Beatrice Njeri Irungu
Lilian C Koech
Joyce M Ondicho
Lucia K Keter
author_facet Beatrice Njeri Irungu
Lilian C Koech
Joyce M Ondicho
Lucia K Keter
author_sort Beatrice Njeri Irungu
title Quality assessment of selected co-trimoxazole suspension brands marketed in Nairobi County, Kenya.
title_short Quality assessment of selected co-trimoxazole suspension brands marketed in Nairobi County, Kenya.
title_full Quality assessment of selected co-trimoxazole suspension brands marketed in Nairobi County, Kenya.
title_fullStr Quality assessment of selected co-trimoxazole suspension brands marketed in Nairobi County, Kenya.
title_full_unstemmed Quality assessment of selected co-trimoxazole suspension brands marketed in Nairobi County, Kenya.
title_sort quality assessment of selected co-trimoxazole suspension brands marketed in nairobi county, kenya.
publisher Public Library of Science (PLoS)
publishDate 2021
url https://doaj.org/article/fd0d18ef9fdf4274873b2e1956c096f4
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AT joycemondicho qualityassessmentofselectedcotrimoxazolesuspensionbrandsmarketedinnairobicountykenya
AT luciakketer qualityassessmentofselectedcotrimoxazolesuspensionbrandsmarketedinnairobicountykenya
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