Journal
JOURNAL OF PHARMACY AND PHARMACOLOGY
Volume 71, Issue 2, Pages 156-166Publisher
WILEY
DOI: 10.1111/jphp.13021
Keywords
alkyltrimethylammonium bromide; benzalkonium chloride; cationic surfactant; cytotoxicity; self-emulsifying drug delivery systems
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Objectives The aim of this study was to evaluate the cytotoxicity of self-emulsifying drug delivery systems (SEDDS) containing five different cationic surfactants. Methods Cationic surfactants were added in a concentration of 1% and 5% (m/m) to SEDDS comprising 30% Capmul MCM, 30% Captex 355, 30% Cremophor EL and 10% propylene glycol. The resulting formulations were characterized in terms of size, zeta potential, in-vitro haemolytic activity and toxicity on Caco-2 via MTT assay and lactate dehydrogenase release assay. Key findings The evaluated surfactants had in both concentrations a minor impact on the size of SEDDS ranging from 30.2 +/- 0.6 to 55.4 +/- 1.1 nm, whereas zeta potential changed significantly from -9.0 +/- 0.3 to +28.8 +/- 1.6 mV. The overall cytotoxicity of cationic surfactants followed the rank order: hexadecylpyridinium chloride > benzalkonium chloride > alkyltrimethylammonium bromide > octylamine > 1-decyl-3-methylimidazolium. The haemolytic activity of the combination of cationic surfactants and SEDDS on human red blood cells was synergistic. Furthermore, cationic SEDDS exhibited higher cytotoxicity of Caco-2 cells compared to SEDDS without cationic surfactants. Conclusions According to these results, SEDDS and cationic surfactants seem to bear an additive up to synergistic toxic risk.
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