Measuring the emulsification dynamics and stability of self-emulsifying drug delivery systems

Eur J Pharm Biopharm. 2018 Feb;123:1-8. doi: 10.1016/j.ejpb.2017.11.003. Epub 2017 Nov 10.


Self-emulsifying drug delivery systems (SEDDS) are one of the most promising technologies in the drug delivery field, particularly for addressing solubility and bioavailability issues of drugs. The development of these drug carriers excessively relies in visual observations and indirect determinations. The present manuscript intended to describe a method able to measure the emulsification of SEDDS, both micro and nano-emulsions, able to measure the droplet size and to evaluate the physical stability of these formulations. Additionally, a new process to evaluate the physical stability of SEDDS after emulsification was also proposed, based on a cycle of mechanical stress followed by a resting period. The use of a multiparameter continuous evaluation during the emulsification process and stability was of upmost value to understand SEDDS emulsification process. Based on this method, SEDDS were classified as fast and slow emulsifiers. Moreover, emulsification process and stabilization of emulsion was subject of several considerations regarding the composition of SEDDS as major factor that affects stability to physical stress and the use of multicomponent with different properties to develop a stable and robust SEDDS formulation. Drug loading level is herein suggested to impact droplets size of SEDDS after dispersion and SEDDS stability to stress conditions. The proposed protocol allows an online measurement of SEDDS droplet size during emulsification and a rationale selection of excipients based on its emulsification and stabilization performance.

Keywords: Bioavailability; Emulsifying agents; Laser diffraction; Lipid-based drug delivery systems; Self-emulsifying drug delivery systems.

MeSH terms

  • Biological Availability
  • Chemistry, Pharmaceutical
  • Drug Carriers / chemistry
  • Drug Delivery Systems / methods
  • Drug Stability
  • Emulsifying Agents / chemistry*
  • Emulsions / chemistry*
  • Excipients / chemistry
  • Nanoparticles / chemistry
  • Particle Size
  • Solubility / drug effects


  • Drug Carriers
  • Emulsifying Agents
  • Emulsions
  • Excipients