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dc.contributor.authorSantoveña Estévez, Ana María 
dc.contributor.authorCáceres Pérez, Amor R.
dc.contributor.authorSuárez González, Javier 
dc.contributor.authorFariña Espinosa, José Bruno Celso 
dc.contributor.otherIngeniería Química y Tecnología Farmacéutica
dc.contributor.otherDesarrollo galénico de medicamentos
dc.date.accessioned2025-01-03T21:05:07Z
dc.date.available2025-01-03T21:05:07Z
dc.date.issued2024
dc.identifier.urihttp://riull.ull.es/xmlui/handle/915/40694
dc.description.abstractMalaria and HumanImmunodeficiency Virus infections are among the top 10 causes of death in low income countries. Furthermore, many medicines used in these treatment areas are substandard, which contributes to the high death rate. Using a monitoring system to identify substandard and falsified medicines, the study aims to evaluate the quality of antimalarial and antiretroviral medicines in Sahel countries, assessing site conditions, compliance of medicines with pharmacopoeia tests, formulation equivalence with a reference medicine, and the influence of climate on quality attributes. Ultra Performance Liquid Chromatography methods for eight active pharmaceutical ingredients were validated following the International Conference for Harmonization guideline for its detection and quantification. Quality control consists of visual inspections to detect any misinformation or imperfections andpharmacopeial testing to determine the quality of pharmaceutical products. Medicines which complied with uniformity dosage units and dissolution tests were stored under accelerated conditions for 6 months. Artemether/Lumefantrine and Lopinavir/Ritonavir formulations failed uniformity dosage units and disintegration tests respectively, detecting a total of 28.6% substandard medicines. After 6 months stored under accelerated conditions (40 ˚C // 75%relative humidity) simulating climatic conditions in Sahel countries, some medicines failed pharmacopeia tests. It demonstrated the influence of these two factors in their quality attributes. This study emphasizes the need of certified quality control laboratories as well as the need for regulatory systems to maintain standards in pharmaceutical manufacturing and distribution in these countries, especially when medicines are transported to rural areas where these climatic conditions are harsher.en
dc.format.mimetypeapplication/pdf
dc.language.isoen
dc.relation.ispartofseriesPLoS ONE 19(5)
dc.rightsLicencia Creative Commons (Reconocimiento-No comercial-Sin obras derivadas 4.0 Internacional)
dc.rightsinfo:eu-repo/semantics/openAccess
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/4.0/deed.es_ES
dc.titleQuality assessment of oral antimalarial and antiretroviral medicines used by public health systems in Sahel countriesen
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1371/journal.pone.0303289


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Licencia Creative Commons (Reconocimiento-No comercial-Sin obras derivadas 4.0 Internacional)
Except where otherwise noted, this item's license is described as Licencia Creative Commons (Reconocimiento-No comercial-Sin obras derivadas 4.0 Internacional)