Cargando…
Physicochemical Quality Assessment of Antimalarial Medicines: Chloroquine Phosphate and Quinine Sulfate Tablets from Drug Retail Outlets of South-West Ethiopia
BACKGROUND: Malaria is a complex disease and main community health problem in Africa and the top leading cause of outpatient visits, admissions, and deaths in Ethiopia. Its effective management is possible through early diagnosis and immediate treatment employing antimalarials. The quality of these...
Autores principales: | , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Dove
2020
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7051250/ https://www.ncbi.nlm.nih.gov/pubmed/32161477 http://dx.doi.org/10.2147/IDR.S234684 |
_version_ | 1783502734860746752 |
---|---|
author | Abuye, Habtamu Abraham, Woldemichael Kebede, Selass Tatiparthi, Ramanjireddy Suleman, Sultan |
author_facet | Abuye, Habtamu Abraham, Woldemichael Kebede, Selass Tatiparthi, Ramanjireddy Suleman, Sultan |
author_sort | Abuye, Habtamu |
collection | PubMed |
description | BACKGROUND: Malaria is a complex disease and main community health problem in Africa and the top leading cause of outpatient visits, admissions, and deaths in Ethiopia. Its effective management is possible through early diagnosis and immediate treatment employing antimalarials. The quality of these drugs has to be good enough to attain their intended purpose. However, there are treatment failures resulted from the consumption of falsified and substandard antimalarials. Therefore, the current study was undertaken to evaluate the quality of two commonly used antimalarial drugs [chloroquine phosphate and quinine sulfate tablets] and to determine whether the quality of these drugs was affected by the origin, brand and sample collection sites in South-West Ethiopia. METHODS: Random sampling based on Ethiopian malaria eco-epidemiological strata map, with different levels of medicines outlets, was applied to select sampling sites. RESULTS: Sixty samples were bought from 43 drug retails (pharmacy, drug store, and drug vendor) in twelve different geographical locations of South-West Ethiopia between June and July 2016. Visual inspection was done for all samples before the lab experiment. A 28.3%, 31.7%, and 6.8% of samples failed to comply with the Pharmacopoeial quality standards for visual inspection, hardness and weight variation tests, respectively. Statistical analysis revealed that origin and geography from which samples were collected significantly affects the active pharmaceutical content of both drugs at P < 0.05 level. Significant variation was observed for chloroquine samples within batches of the same manufacturing and between origins. CONCLUSION: This study indicated that all the chloroquine and quinine tablets met the quality specification concerning friability, dissolution and assay. Out-of-specification results for weight variation, hardness and visual inspection tests for the chloroquine tablets are signs of substandard/spurious/falsely labeled/falsified/counterfeit actions that may compromise the quality of these drugs. Besides, within the acceptance limit, the origin of drugs and collection sites have found to determine the quality which raises good manufacturing practice and storage (drug supply chain system) issues to be evaluated. |
format | Online Article Text |
id | pubmed-7051250 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Dove |
record_format | MEDLINE/PubMed |
spelling | pubmed-70512502020-03-11 Physicochemical Quality Assessment of Antimalarial Medicines: Chloroquine Phosphate and Quinine Sulfate Tablets from Drug Retail Outlets of South-West Ethiopia Abuye, Habtamu Abraham, Woldemichael Kebede, Selass Tatiparthi, Ramanjireddy Suleman, Sultan Infect Drug Resist Original Research BACKGROUND: Malaria is a complex disease and main community health problem in Africa and the top leading cause of outpatient visits, admissions, and deaths in Ethiopia. Its effective management is possible through early diagnosis and immediate treatment employing antimalarials. The quality of these drugs has to be good enough to attain their intended purpose. However, there are treatment failures resulted from the consumption of falsified and substandard antimalarials. Therefore, the current study was undertaken to evaluate the quality of two commonly used antimalarial drugs [chloroquine phosphate and quinine sulfate tablets] and to determine whether the quality of these drugs was affected by the origin, brand and sample collection sites in South-West Ethiopia. METHODS: Random sampling based on Ethiopian malaria eco-epidemiological strata map, with different levels of medicines outlets, was applied to select sampling sites. RESULTS: Sixty samples were bought from 43 drug retails (pharmacy, drug store, and drug vendor) in twelve different geographical locations of South-West Ethiopia between June and July 2016. Visual inspection was done for all samples before the lab experiment. A 28.3%, 31.7%, and 6.8% of samples failed to comply with the Pharmacopoeial quality standards for visual inspection, hardness and weight variation tests, respectively. Statistical analysis revealed that origin and geography from which samples were collected significantly affects the active pharmaceutical content of both drugs at P < 0.05 level. Significant variation was observed for chloroquine samples within batches of the same manufacturing and between origins. CONCLUSION: This study indicated that all the chloroquine and quinine tablets met the quality specification concerning friability, dissolution and assay. Out-of-specification results for weight variation, hardness and visual inspection tests for the chloroquine tablets are signs of substandard/spurious/falsely labeled/falsified/counterfeit actions that may compromise the quality of these drugs. Besides, within the acceptance limit, the origin of drugs and collection sites have found to determine the quality which raises good manufacturing practice and storage (drug supply chain system) issues to be evaluated. Dove 2020-02-27 /pmc/articles/PMC7051250/ /pubmed/32161477 http://dx.doi.org/10.2147/IDR.S234684 Text en © 2020 Abuye et al. http://creativecommons.org/licenses/by-nc/3.0/ This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). |
spellingShingle | Original Research Abuye, Habtamu Abraham, Woldemichael Kebede, Selass Tatiparthi, Ramanjireddy Suleman, Sultan Physicochemical Quality Assessment of Antimalarial Medicines: Chloroquine Phosphate and Quinine Sulfate Tablets from Drug Retail Outlets of South-West Ethiopia |
title | Physicochemical Quality Assessment of Antimalarial Medicines: Chloroquine Phosphate and Quinine Sulfate Tablets from Drug Retail Outlets of South-West Ethiopia |
title_full | Physicochemical Quality Assessment of Antimalarial Medicines: Chloroquine Phosphate and Quinine Sulfate Tablets from Drug Retail Outlets of South-West Ethiopia |
title_fullStr | Physicochemical Quality Assessment of Antimalarial Medicines: Chloroquine Phosphate and Quinine Sulfate Tablets from Drug Retail Outlets of South-West Ethiopia |
title_full_unstemmed | Physicochemical Quality Assessment of Antimalarial Medicines: Chloroquine Phosphate and Quinine Sulfate Tablets from Drug Retail Outlets of South-West Ethiopia |
title_short | Physicochemical Quality Assessment of Antimalarial Medicines: Chloroquine Phosphate and Quinine Sulfate Tablets from Drug Retail Outlets of South-West Ethiopia |
title_sort | physicochemical quality assessment of antimalarial medicines: chloroquine phosphate and quinine sulfate tablets from drug retail outlets of south-west ethiopia |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7051250/ https://www.ncbi.nlm.nih.gov/pubmed/32161477 http://dx.doi.org/10.2147/IDR.S234684 |
work_keys_str_mv | AT abuyehabtamu physicochemicalqualityassessmentofantimalarialmedicineschloroquinephosphateandquininesulfatetabletsfromdrugretailoutletsofsouthwestethiopia AT abrahamwoldemichael physicochemicalqualityassessmentofantimalarialmedicineschloroquinephosphateandquininesulfatetabletsfromdrugretailoutletsofsouthwestethiopia AT kebedeselass physicochemicalqualityassessmentofantimalarialmedicineschloroquinephosphateandquininesulfatetabletsfromdrugretailoutletsofsouthwestethiopia AT tatiparthiramanjireddy physicochemicalqualityassessmentofantimalarialmedicineschloroquinephosphateandquininesulfatetabletsfromdrugretailoutletsofsouthwestethiopia AT sulemansultan physicochemicalqualityassessmentofantimalarialmedicineschloroquinephosphateandquininesulfatetabletsfromdrugretailoutletsofsouthwestethiopia |