Post-marketing assessment of content and efficacy of preservatives in artemisinin-derived antimalarial dry suspensions for paediatric use
Abstract Background Artemisinin-derivative formulations are now widely used to treat falciparum malaria. However, the dry powder suspensions developed for children are few and/or are of poor quality. In addition to the active compound, the presence of a suitable preservative in these medicines is es...
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ftdoajarticles:oai:doaj.org/article:6f4dfe4a1041421fa84dcce8a316f7ba 2023-05-15T15:16:16+02:00 Post-marketing assessment of content and efficacy of preservatives in artemisinin-derived antimalarial dry suspensions for paediatric use Plaizier-Vercammen Jacqueline De Cock Katelijne Atemnkeng Magnus A 2007-01-01T00:00:00Z https://doi.org/10.1186/1475-2875-6-12 https://doaj.org/article/6f4dfe4a1041421fa84dcce8a316f7ba EN eng BMC http://www.malariajournal.com/content/6/1/12 https://doaj.org/toc/1475-2875 doi:10.1186/1475-2875-6-12 1475-2875 https://doaj.org/article/6f4dfe4a1041421fa84dcce8a316f7ba Malaria Journal, Vol 6, Iss 1, p 12 (2007) Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 article 2007 ftdoajarticles https://doi.org/10.1186/1475-2875-6-12 2022-12-31T13:51:27Z Abstract Background Artemisinin-derivative formulations are now widely used to treat falciparum malaria. However, the dry powder suspensions developed for children are few and/or are of poor quality. In addition to the active compound, the presence of a suitable preservative in these medicines is essential. In this study, an evaluation of the preservative content and efficacy in some dry suspensions available on the Kenyan market was performed. Method UV spectrophotometry was used to identify the preservatives in each sample while HPLC-UV was used for quantification. After reconstitution of the powders in water, the dissolution of the preservatives was followed for 7 days. Antimicrobial efficacy of the preservatives was assessed by conducting a preservative efficacy test (PET) following the European pharmacopoeia standards. Results Four different preservatives were identified namely methylparahydroxybenzoate (MP), propylparahydroxybenzoate (PP), benzoic acid and sorbic acid. MP and PP were identified in Artesiane ® (artemether 300 mg/100 ml), Alaxin ® (dihydroartemisinin 160 mg/80 ml) andGvither ® (artemether 300 mg/100 ml) respectively. Sorbic acid was presentin Artenam ® (artemether 180 mg/60 ml) while benzoic acid was identified in Santecxin ® (dihydroartemisinin 160 mg/80 ml) andArtexin ® (dihydroartemisinin 160 mg/80 ml) respectively. Cotecxin ® (dihydroartemisinin 160 mg/80 ml) did not contain any of the above preservatives. After reconstitution in water, preservativesin 50%(3/6) of the products did not completely dissolve and the PET results revealed that only Artenam ® and Gvither ® met the requirements for antimicrobial efficacy. The other products did not conform. Conclusion These results show that paediatric antimalarial dry powder formulations on the market may contain ineffective or incorrect amounts of preservatives. This is a potential risk to the patient. Studies conducted on the dry powder suspensions should include the analysis of both the active ingredient and the preservative, including the ... Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic Malaria Journal 6 1 12 |
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Directory of Open Access Journals: DOAJ Articles |
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ftdoajarticles |
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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 Plaizier-Vercammen Jacqueline De Cock Katelijne Atemnkeng Magnus A Post-marketing assessment of content and efficacy of preservatives in artemisinin-derived antimalarial dry suspensions for paediatric use |
topic_facet |
Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 |
description |
Abstract Background Artemisinin-derivative formulations are now widely used to treat falciparum malaria. However, the dry powder suspensions developed for children are few and/or are of poor quality. In addition to the active compound, the presence of a suitable preservative in these medicines is essential. In this study, an evaluation of the preservative content and efficacy in some dry suspensions available on the Kenyan market was performed. Method UV spectrophotometry was used to identify the preservatives in each sample while HPLC-UV was used for quantification. After reconstitution of the powders in water, the dissolution of the preservatives was followed for 7 days. Antimicrobial efficacy of the preservatives was assessed by conducting a preservative efficacy test (PET) following the European pharmacopoeia standards. Results Four different preservatives were identified namely methylparahydroxybenzoate (MP), propylparahydroxybenzoate (PP), benzoic acid and sorbic acid. MP and PP were identified in Artesiane ® (artemether 300 mg/100 ml), Alaxin ® (dihydroartemisinin 160 mg/80 ml) andGvither ® (artemether 300 mg/100 ml) respectively. Sorbic acid was presentin Artenam ® (artemether 180 mg/60 ml) while benzoic acid was identified in Santecxin ® (dihydroartemisinin 160 mg/80 ml) andArtexin ® (dihydroartemisinin 160 mg/80 ml) respectively. Cotecxin ® (dihydroartemisinin 160 mg/80 ml) did not contain any of the above preservatives. After reconstitution in water, preservativesin 50%(3/6) of the products did not completely dissolve and the PET results revealed that only Artenam ® and Gvither ® met the requirements for antimicrobial efficacy. The other products did not conform. Conclusion These results show that paediatric antimalarial dry powder formulations on the market may contain ineffective or incorrect amounts of preservatives. This is a potential risk to the patient. Studies conducted on the dry powder suspensions should include the analysis of both the active ingredient and the preservative, including the ... |
format |
Article in Journal/Newspaper |
author |
Plaizier-Vercammen Jacqueline De Cock Katelijne Atemnkeng Magnus A |
author_facet |
Plaizier-Vercammen Jacqueline De Cock Katelijne Atemnkeng Magnus A |
author_sort |
Plaizier-Vercammen Jacqueline |
title |
Post-marketing assessment of content and efficacy of preservatives in artemisinin-derived antimalarial dry suspensions for paediatric use |
title_short |
Post-marketing assessment of content and efficacy of preservatives in artemisinin-derived antimalarial dry suspensions for paediatric use |
title_full |
Post-marketing assessment of content and efficacy of preservatives in artemisinin-derived antimalarial dry suspensions for paediatric use |
title_fullStr |
Post-marketing assessment of content and efficacy of preservatives in artemisinin-derived antimalarial dry suspensions for paediatric use |
title_full_unstemmed |
Post-marketing assessment of content and efficacy of preservatives in artemisinin-derived antimalarial dry suspensions for paediatric use |
title_sort |
post-marketing assessment of content and efficacy of preservatives in artemisinin-derived antimalarial dry suspensions for paediatric use |
publisher |
BMC |
publishDate |
2007 |
url |
https://doi.org/10.1186/1475-2875-6-12 https://doaj.org/article/6f4dfe4a1041421fa84dcce8a316f7ba |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
Malaria Journal, Vol 6, Iss 1, p 12 (2007) |
op_relation |
http://www.malariajournal.com/content/6/1/12 https://doaj.org/toc/1475-2875 doi:10.1186/1475-2875-6-12 1475-2875 https://doaj.org/article/6f4dfe4a1041421fa84dcce8a316f7ba |
op_doi |
https://doi.org/10.1186/1475-2875-6-12 |
container_title |
Malaria Journal |
container_volume |
6 |
container_issue |
1 |
container_start_page |
12 |
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1766346564701257728 |