Physical and chemical stability of expired fixed dose combination artemether-lumefantrine in uncontrolled tropical conditions
Abstract Background New artemisinin combination therapies pose difficulties of implementation in developing and tropical settings because they have a short shelf-life (two years) relative to the medicines they replace. This limits the reliability and cost of treatment, and the acceptability of this...
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ftdoajarticles:oai:doaj.org/article:4629de8eef324e9a8291374a80de6f66 2023-05-15T15:14:57+02:00 Physical and chemical stability of expired fixed dose combination artemether-lumefantrine in uncontrolled tropical conditions Hess Kimberly Tren Richard Bate Roger Attaran Amir 2009-02-01T00:00:00Z https://doi.org/10.1186/1475-2875-8-33 https://doaj.org/article/4629de8eef324e9a8291374a80de6f66 EN eng BMC http://www.malariajournal.com/content/8/1/33 https://doaj.org/toc/1475-2875 doi:10.1186/1475-2875-8-33 1475-2875 https://doaj.org/article/4629de8eef324e9a8291374a80de6f66 Malaria Journal, Vol 8, Iss 1, p 33 (2009) Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 article 2009 ftdoajarticles https://doi.org/10.1186/1475-2875-8-33 2022-12-31T08:12:21Z Abstract Background New artemisinin combination therapies pose difficulties of implementation in developing and tropical settings because they have a short shelf-life (two years) relative to the medicines they replace. This limits the reliability and cost of treatment, and the acceptability of this treatment to health care workers. A multi-pronged investigation was made into the chemical and physical stability of fixed dose combination artemether-lumefantrine (FDC-ALU) stored under heterogeneous, uncontrolled African conditions, to probe if a shelf-life extension might be possible. Methods Seventy samples of expired FDC-ALU were collected from private pharmacies and malaria researchers in seven African countries. The samples were subjected to thin-layer chromatography (TLC), disintegration testing, and near infrared Raman spectrometry for ascertainment of active ingredients, tablet integrity, and chemical degradation of the tablet formulation including both active ingredients and excipients. Results Seventy samples of FDC-ALU were tested in July 2008, between one and 58 months post-expiry. 68 of 70 (97%) samples passed TLC, disintegration and Raman spectrometry testing, including eight samples that were post-expiry by 20 months or longer. A weak linear association (R 2 = 0.33) was observed between the age of samples and their state of degradation relative to brand-identical samples on Raman spectrometry. Sixty-eight samples were retested in February 2009 using Raman spectrometry, between eight and 65 months post-expiry. 66 of 68 (97%) samples passed Raman spectrometry retesting. An unexpected observation about African drug logistics was made in three batches of FDC-ALU, which had been sold into the public sector at concessional pricing in accordance with a World Health Organization (WHO) agreement, and which were illegally diverted to the private sector where they were sold for profit. Conclusion The data indicate that FDC-ALU is chemically and physically stable well beyond its stated shelf-life in uncontrolled, ... Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic Malaria Journal 8 1 |
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Directory of Open Access Journals: DOAJ Articles |
op_collection_id |
ftdoajarticles |
language |
English |
topic |
Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 |
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Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 Hess Kimberly Tren Richard Bate Roger Attaran Amir Physical and chemical stability of expired fixed dose combination artemether-lumefantrine in uncontrolled tropical conditions |
topic_facet |
Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 |
description |
Abstract Background New artemisinin combination therapies pose difficulties of implementation in developing and tropical settings because they have a short shelf-life (two years) relative to the medicines they replace. This limits the reliability and cost of treatment, and the acceptability of this treatment to health care workers. A multi-pronged investigation was made into the chemical and physical stability of fixed dose combination artemether-lumefantrine (FDC-ALU) stored under heterogeneous, uncontrolled African conditions, to probe if a shelf-life extension might be possible. Methods Seventy samples of expired FDC-ALU were collected from private pharmacies and malaria researchers in seven African countries. The samples were subjected to thin-layer chromatography (TLC), disintegration testing, and near infrared Raman spectrometry for ascertainment of active ingredients, tablet integrity, and chemical degradation of the tablet formulation including both active ingredients and excipients. Results Seventy samples of FDC-ALU were tested in July 2008, between one and 58 months post-expiry. 68 of 70 (97%) samples passed TLC, disintegration and Raman spectrometry testing, including eight samples that were post-expiry by 20 months or longer. A weak linear association (R 2 = 0.33) was observed between the age of samples and their state of degradation relative to brand-identical samples on Raman spectrometry. Sixty-eight samples were retested in February 2009 using Raman spectrometry, between eight and 65 months post-expiry. 66 of 68 (97%) samples passed Raman spectrometry retesting. An unexpected observation about African drug logistics was made in three batches of FDC-ALU, which had been sold into the public sector at concessional pricing in accordance with a World Health Organization (WHO) agreement, and which were illegally diverted to the private sector where they were sold for profit. Conclusion The data indicate that FDC-ALU is chemically and physically stable well beyond its stated shelf-life in uncontrolled, ... |
format |
Article in Journal/Newspaper |
author |
Hess Kimberly Tren Richard Bate Roger Attaran Amir |
author_facet |
Hess Kimberly Tren Richard Bate Roger Attaran Amir |
author_sort |
Hess Kimberly |
title |
Physical and chemical stability of expired fixed dose combination artemether-lumefantrine in uncontrolled tropical conditions |
title_short |
Physical and chemical stability of expired fixed dose combination artemether-lumefantrine in uncontrolled tropical conditions |
title_full |
Physical and chemical stability of expired fixed dose combination artemether-lumefantrine in uncontrolled tropical conditions |
title_fullStr |
Physical and chemical stability of expired fixed dose combination artemether-lumefantrine in uncontrolled tropical conditions |
title_full_unstemmed |
Physical and chemical stability of expired fixed dose combination artemether-lumefantrine in uncontrolled tropical conditions |
title_sort |
physical and chemical stability of expired fixed dose combination artemether-lumefantrine in uncontrolled tropical conditions |
publisher |
BMC |
publishDate |
2009 |
url |
https://doi.org/10.1186/1475-2875-8-33 https://doaj.org/article/4629de8eef324e9a8291374a80de6f66 |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
Malaria Journal, Vol 8, Iss 1, p 33 (2009) |
op_relation |
http://www.malariajournal.com/content/8/1/33 https://doaj.org/toc/1475-2875 doi:10.1186/1475-2875-8-33 1475-2875 https://doaj.org/article/4629de8eef324e9a8291374a80de6f66 |
op_doi |
https://doi.org/10.1186/1475-2875-8-33 |
container_title |
Malaria Journal |
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8 |
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1 |
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1766345341420961792 |