生物利用度
非诺贝特
介孔二氧化硅
生物等效性
化学
药理学
药代动力学
溶解度
介孔材料
吸收(声学)
活性代谢物
剂型
最大值
控制释放
色谱法
材料科学
医学
有机化学
复合材料
催化作用
作者
Katarina Bukara,Laurent Schueller,Jan Rosier,Mark A. Martens,Tinne Daems,Loes Verheyden,Siemon Eelen,Michiel Van Speybroeck,Cristian Libanati,Jürgen Martens,Guy Van den Mooter,Françoise Frérart,Koen Jolling,M. De Gieter,Branko Bugarski,Filip Kiekens
标识
DOI:10.1016/j.ejpb.2016.08.020
摘要
Formulating poorly water soluble drugs using ordered mesoporous silica materials is an emerging approach to tackle solubility-related bioavailability problems. The current study was conducted to assess the bioavailability-enhancing potential of ordered mesoporous silica in man. In this open-label, randomized, two-way cross-over study, 12 overnight fasted healthy volunteers received a single dose of fenofibrate formulated with ordered mesoporous silica or a marketed product based on micronized fenofibrate. Plasma concentrations of fenofibric acid, the pharmacologically active metabolite of fenofibrate, were monitored up to 96 h post-dose. The rate (Cmax/dose increased by 77%; tmax reduced by 0.75 h) and extent of absorption (AUC0–24h/dose increased by 54%) of fenofibrate were significantly enhanced following administration of the ordered mesoporous silica based formulation. The results of this study serve as a proof of concept in man for this novel formulation approach.
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