Comparative Bioavailability Study of Solid Self-Nanoemulsifying Drug Delivery System of Fenofibric Acid in Healthy Male Subjects

• Published in: Medical principles and practice Vol. 31; no. 2; pp. 142 - 148
• Main Authors: Suhery, Wira Noviana, Mudhakir, Diky, Sumirtapura, Yeyet Cahyati, Pamudji, Jessie Sofia
• Format: Journal Article
• Language: English
• Published: Basel, Switzerland S. Karger AG 01.05.2022
• Subjects: Acids; Administration, Oral; Bioavailability; Biological Availability; Drug delivery systems; Drug Delivery Systems - methods; Drug dosages; Emulsions; Enzymes; Fenofibrate - analogs & derivatives; Human subjects; Humans; Male; Nanoparticles - chemistry; Original Paper; Particle Size; Pharmacokinetics; Plasma; Polyethylene glycol; Solubility; Surfactants; Triglycerides; Germany; S-SNEDDS; Fenofibric acid; Comparative bioavailability
• ISSN: 1011-7571; 1423-0151; 1423-0151
• DOI: 10.1159/000522380

Objective: This study aimed to evaluate the effect of solid self-nanoemulsifying drug delivery system (S-SNEDDS) formation on the bioavailability of fenofibric acid. Subject and Methods: Three formulations of fenofibric acid, namely, S-SNEDDS containing medium-chain triglyceride (FS1), S-SNEDDS containing long-chain triglyceride (FS2), and FSt as tablet of innovator product, were used in this study. Bioavailability study was conducted in 12 Indonesian healthy male subjects after a single-dose administration of each formulation with three-way crossover design. Blood samples were collected from 0 to 72 h after drug administration and then analyzed using the high-performance liquid chromatography method. Data were statistically analyzed using the ANOVA and the Wilcoxon signed-rank test using a p value of 0.05. Dissolution test was carried out with USP dissolution apparatus using three medium (pH 1.2, 4.5 and 6.8). Results: The rates of absorption of fenofibric acid from S-SNEDDS FS1 and FS2 were significantly increased about 1.78 and 2.40 times, respectively, relative to FSt. T max values of FS1 and FS2 were shorter than FSt, namely, 0.96 ± 0.438 h (FS1), 0.71 ± 0.445 h (FS2), and 1.71 ± 0.840 h (FSt), respectively. Meanwhile, the C max and AUC values of FS1, FS2, and FSt were found to be not significantly different with a p value of >0.05. S-SNEDDS formation increased the dissolution rate in acid medium. Conclusions: S-SNEDDS increased the dissolution rate in acid medium and absorption rate of fenofibric acid but did not increase the extent of fenofibric acid absorption.