Novel polyglycerol-dioleate based cubosomal dispersion with tailored physical characteristics for controlled delivery of ondansetron.

In this study different amphiphilic lipids viz. glycerylmonooleate (GMO), Glycerylmonolinoleate (GML), Plurol® (polyglycerol 3-dioleate), Soya phosphatidylcholine (Soya PC), Dipalmitoyl-phosphatidylcholine (DPPC) and Dipalmitoyl- phosphatidylglycerol (DPPG) were screened for their ability to form cubosomes and the formed particles were optimized for controlled delivery using ondansetron as a model drug. Polarized optical microscopy and high resolution transmission electron microscopy were performed to investigate the morphology of the prepared particles. A full factorial study was developed to optimize formulation composition and process conditions. Atomic force microscopy and in vitro drug release studies were done on selected formulae. Results showed that GMO, Plurol and GML were able to form cubosomes while DPPC was able to form spherical nanoparticles. There was a negative correlation between homogenization speed and PS, PDI and EE%. Furthermore, there was a significant positive correlation between Lipid: Polymer ratio and PS as well as PDI values, while there was a slight negative correlation between it and EE% in all nanoparticles except for those based on DPPC, which showed significant increase in EE% upon increase in the lipid:polymer ratio. Additionally, cumulative percent release of ondansetron from the particles shows that their design was efficiently tailored throughout this study to afford sustained drug release with diffusion pattern. T80 reached 19.3h in case of Plurol. Further confirmation studies on cubic structure formation were done on selected GMO and Plurol-based nanoparticles using scanning electron microscopy and x-ray powder diffraction. Results showed that Plurol was able to form cubic nanostrucures resembling those formed by GMO. Finally, Plurol (polyglyceroldioleate) showed to be a promising amphiphilic lipid that is capable of forming cubic nanostructures like GMO opening a new era for polyglycerols to take a step as a self assembling lipid resembling the unsaturated monoglycerols (UMGs).