THE EFFECT OF FOOD ON THE DISINTEGRATION TIME AND DISSOLUTION PROFILE OF ARTEMETHER-LUMEFANTRINE TABLET

International Journal of Biomedical and Advance Research

Umoren Fabian James¹  Awofisayo Sunday Olajide¹  Ekpo Kufre Michael¹  Uwanta Emaime Jimmy¹ 

关键词: Artemether- lumefantrine;    food effect;    simulated fluid;   

DOI  :  10.7439/ijbar.v3i9.582

学科分类：药学、药理学、毒理学（综合）

来源: Scholar Science Journals

【 摘 要 】

This study aimed at comparing the release rate of artemether-lumefantrine tablets through artemether release in the presence of simulated gastric fluid (SGF), simulated intestinal fluid (SIF) and food modified simulated gastric fluid (FMSGF) and intestinal fluid (FMSIF). Various quality control parameters including weight uniformity, tablet hardness, disintegration, friability and assay were assessed. SGF and SIF were employed as disintegration and dissolution media and compared with a food (1.3 ml full cream unsweetened evaporated milk, 2.67mg soluble starch) modified SIF and SGF (FMSIF and FMSGF) at 37 ?? 0.5 o C. The product assessed complied with the official specification for uniformity of weight friability and assay. The titrimetric and spectrophotometric assays gave 97.45% and 103.25% of artemether content respectively (P<0.05). No significant differences were observed between the disintegration time for FMSGF and SGF (5.0min and 5.5min) for SIF and FMSIF (7.5min and 6.5min) respectively. There was significant difference in the percentage drug release in FMSGF compared to SGF (35% v 58%) ??but no significant difference in the release rate for media simulating dosing conditions in the intestine, FMSIF and SIF( 28% v 29%) respectively at P<0.05. Artemether-lumefantrine is well absorbed in the stomach and in the ??fasted state dosing condition. "

【 授权许可】

CC BY