Effect of fixed-dose sizes on in vitro properties of artemether-lumefantrine tablets

Journal of Pharmacy & Bioresources Pub Date : 2018-12-05 DOI:10.4314/JPB.V15I2.13

Olubukola A. Odeniran, O. Obodozie-Ofoegbu, J. Nwogu, C. Babalola

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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

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固定剂量对蒿甲醚-氨苯曲明片体外性质的影响

世界卫生组织建议采用青蒿素联合疗法治疗无并发症的疟疾。甲醚-甲芳碱(a -l)是两种抗疟活性成分的固定剂量组合。三种FDC的药物等效性(PE):复方蒿甲醚®(20/120 mg);测定B (40/240 mg)和C (80/480 mg)。a - l分别用高效液相色谱法测定。复方蒿甲醚、复方蒿甲醚、复方蒿甲醚的含量分别为93.34%、98.27%和100.78%，复方蒿甲醚的含量分别为96.44%、97.34%和93.52%。在溶出度试验中，复方蒿甲醚®、B和C在1 h后的平均释放率分别为38.67%、32.86%和50.74%。氟苯曲明45min后分别为93.89%、64.39%和64.76%。所得资料采用方差分析进行比较，差异无统计学意义(P < 0.05)。B和C的f2值均大于50，与复方蒿甲醚相似。本研究的重点是评价它们的体外特性和综合性能。关键词:蒿甲醚-氨芳汀片;固定剂量组合;制药等价;抗疟药

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Journal of Pharmacy & Bioresources

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