Olubukola A. Odeniran, O. Obodozie-Ofoegbu, J. Nwogu, C. Babalola
{"title":"固定剂量对蒿甲醚-氨苯曲明片体外性质的影响","authors":"Olubukola A. Odeniran, O. Obodozie-Ofoegbu, J. Nwogu, C. Babalola","doi":"10.4314/JPB.V15I2.13","DOIUrl":null,"url":null,"abstract":"The World Health Organization recommends artemisinin combination therapy (ACT) for the treatment of uncomplicated malaria. Artemether-lumefantrine (A-L) is a fixed-dose combination (FDC) of two active antimalarial ingredients. Pharmaceutical equivalence (PE) of three FDC: Coartem ® (20/120 mg); B (40/240 mg) and C (80/480 mg) were investigated. Assay was performed for A-L separately with a validated HPLC method. Assay for artemether in Coartem ® , B and C were 93.34%, 98.27% and 100.78% while for lumefantrine 96.44 %, 97.34 % and 93.52 % respectively were obtained. From the dissolution test, the mean percent of artemether released after 1 h for Coartem ® , B, and C were 38.67%, 32.86% and 50.74% respectively. Lumefantrine after 45mins gave 93.89%, 64.39% and 64.76% respectively. The data obtained were compared using ANOVA which was not statistically significant (P>0.05). The f2 values for B & C was greater than 50 suggesting their similarity with Coartem ® . The focus of this study is to evaluate their in vitro properties and their overall performance. Keywords: Artemether-lumefantrine tablets; Fixed-dose combination; Pharmaceutical equivalence; Antimalarial","PeriodicalId":16803,"journal":{"name":"Journal of Pharmacy & Bioresources","volume":"1 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2018-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effect of fixed-dose sizes on in vitro properties of artemether-lumefantrine tablets\",\"authors\":\"Olubukola A. Odeniran, O. Obodozie-Ofoegbu, J. Nwogu, C. Babalola\",\"doi\":\"10.4314/JPB.V15I2.13\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"The World Health Organization recommends artemisinin combination therapy (ACT) for the treatment of uncomplicated malaria. Artemether-lumefantrine (A-L) is a fixed-dose combination (FDC) of two active antimalarial ingredients. Pharmaceutical equivalence (PE) of three FDC: Coartem ® (20/120 mg); B (40/240 mg) and C (80/480 mg) were investigated. Assay was performed for A-L separately with a validated HPLC method. Assay for artemether in Coartem ® , B and C were 93.34%, 98.27% and 100.78% while for lumefantrine 96.44 %, 97.34 % and 93.52 % respectively were obtained. From the dissolution test, the mean percent of artemether released after 1 h for Coartem ® , B, and C were 38.67%, 32.86% and 50.74% respectively. Lumefantrine after 45mins gave 93.89%, 64.39% and 64.76% respectively. The data obtained were compared using ANOVA which was not statistically significant (P>0.05). The f2 values for B & C was greater than 50 suggesting their similarity with Coartem ® . The focus of this study is to evaluate their in vitro properties and their overall performance. Keywords: Artemether-lumefantrine tablets; Fixed-dose combination; Pharmaceutical equivalence; Antimalarial\",\"PeriodicalId\":16803,\"journal\":{\"name\":\"Journal of Pharmacy & Bioresources\",\"volume\":\"1 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2018-12-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Pharmacy & Bioresources\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.4314/JPB.V15I2.13\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Pharmacy & Bioresources","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.4314/JPB.V15I2.13","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Effect of fixed-dose sizes on in vitro properties of artemether-lumefantrine tablets
The World Health Organization recommends artemisinin combination therapy (ACT) for the treatment of uncomplicated malaria. Artemether-lumefantrine (A-L) is a fixed-dose combination (FDC) of two active antimalarial ingredients. Pharmaceutical equivalence (PE) of three FDC: Coartem ® (20/120 mg); B (40/240 mg) and C (80/480 mg) were investigated. Assay was performed for A-L separately with a validated HPLC method. Assay for artemether in Coartem ® , B and C were 93.34%, 98.27% and 100.78% while for lumefantrine 96.44 %, 97.34 % and 93.52 % respectively were obtained. From the dissolution test, the mean percent of artemether released after 1 h for Coartem ® , B, and C were 38.67%, 32.86% and 50.74% respectively. Lumefantrine after 45mins gave 93.89%, 64.39% and 64.76% respectively. The data obtained were compared using ANOVA which was not statistically significant (P>0.05). The f2 values for B & C was greater than 50 suggesting their similarity with Coartem ® . The focus of this study is to evaluate their in vitro properties and their overall performance. Keywords: Artemether-lumefantrine tablets; Fixed-dose combination; Pharmaceutical equivalence; Antimalarial
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