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dc.contributor.authorMwamwitwa, Kissa W.
dc.contributor.authorKaibere, Raphael M.
dc.contributor.authorFimbo, Adam M.
dc.contributor.authorSabitii, Wilber
dc.contributor.authorNtinginya, Nyanda E.
dc.contributor.authorMmbaga, Blandina T.
dc.contributor.authorShewiyo, Danstan H.
dc.contributor.authorShearer, Morven C.
dc.contributor.authorSmith, Andrew D.
dc.contributor.authorKaale, Eliangiringa A.
dc.date.accessioned2020-10-21T10:30:02Z
dc.date.available2020-10-21T10:30:02Z
dc.date.issued2020-10-20
dc.identifier.citationMwamwitwa , K W , Kaibere , R M , Fimbo , A M , Sabitii , W , Ntinginya , N E , Mmbaga , B T , Shewiyo , D H , Shearer , M C , Smith , A D & Kaale , E A 2020 , ' A retrospective cross-sectional study to determine chirality status of registered medicines in Tanzania ' , Scientific Reports , vol. 10 , no. 1 , 17834 . https://doi.org/10.1038/s41598-020-74932-xen
dc.identifier.issn2045-2322
dc.identifier.otherPURE: 270820175
dc.identifier.otherPURE UUID: 7c5768ad-c765-4e77-9e76-581e684736df
dc.identifier.otherRIS: urn:303CDB9C00209C587BE51582BED11A49
dc.identifier.otherRIS: Mwamwitwa2020
dc.identifier.otherORCID: /0000-0002-2104-7313/work/82500863
dc.identifier.otherORCID: /0000-0002-9180-6928/work/82500872
dc.identifier.otherORCID: /0000-0002-4742-2791/work/82501126
dc.identifier.otherScopus: 85093122732
dc.identifier.otherWOS: 000585239000008
dc.identifier.urihttp://hdl.handle.net/10023/20806
dc.descriptionFunding: European and Developing Countries Clinical Trials Partnership (EDCTP) under Streamlining Health Research Ethics Review and Regulatory Framework in Tanzania (SMERT) project.en
dc.description.abstractMedicines with a stereogenic center (asymmetric carbon) are mainly present as racemates with a mixture of equal amounts of enantiomers. One enantiomer may be active while the other inactive, alternatively one may produce side-effects and even toxicity. However, there is lack of information on the chirality status (either racemates, single active enantiomer or achiral) of medicines circulated on the market particularly in African countries. We established the chirality status of registered medicines in Tanzania by conducting a retrospective cross-sectional study. Registration data for the past 15 years from 2003 to 2018 were extracted from TMDA-IMIS database to Microsoft excel for review and analysis. A total of 3,573 human medicines had valid registration. Out of which 2,150 (60%) were chiral and 1,423 (40%) achiral. Out of the chiral medicines, 1,591 (74%) and 559 (26%) were racemates and single active enantiomers, respectively. The proportion of racemates within chiral medicines was considerably higher than single enantiomer medicines. The use of racemates may cause harm to the public and may contribute to antimicrobial resistance due to potential existence of inactive and toxic enantiomers. In order to protect public health, regulatory bodies need to strengthen control of chiral medicines by conducting analysis of enantiomeric impurity.
dc.format.extent11
dc.language.isoeng
dc.relation.ispartofScientific Reportsen
dc.rightsCopyright © 2020 the Author(s). Open Access. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.en
dc.subjectRA0421 Public health. Hygiene. Preventive Medicineen
dc.subjectRM Therapeutics. Pharmacologyen
dc.subject3rd-DASen
dc.subject.lccRA0421en
dc.subject.lccRMen
dc.titleA retrospective cross-sectional study to determine chirality status of registered medicines in Tanzaniaen
dc.typeJournal articleen
dc.description.versionPublisher PDFen
dc.contributor.institutionUniversity of St Andrews.Infection and Global Health Divisionen
dc.contributor.institutionUniversity of St Andrews.School of Medicineen
dc.contributor.institutionUniversity of St Andrews.Centre for Higher Education Researchen
dc.contributor.institutionUniversity of St Andrews.Institute of Behavioural and Neural Sciencesen
dc.contributor.institutionUniversity of St Andrews.St Andrews Sustainability Instituteen
dc.contributor.institutionUniversity of St Andrews.Education Divisionen
dc.contributor.institutionUniversity of St Andrews.School of Chemistryen
dc.identifier.doihttps://doi.org/10.1038/s41598-020-74932-x
dc.description.statusPeer revieweden


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