Physicochemical characterization of a DMPC-based nanoemulsion for dry eye and compatibility test with soft contact lenses in vitro.

Introduction: The use of contact lenses (CL) is often associated with hallmark symptoms of dry eye disease (DED) such as red eye and dryness. Even though lipid-based artificial tears are already marketed for DED, there is little evidence that supports their use while wearing soft CL.

Methods: An oil in water (O/W) nanoemulsion was formulated with a highly-stable oily phase composed of castor oil and 1,2-dimyristoyl-sn-glycero-3-phosphocholine (DMPC). Physicochemical characterization of the DMPC-based nanoemulsion (DMPC-NE) was performed using the Zetasizer Nano ZSP, and its long-term stability was evaluated over 24 months; in addition, the in vitro cytotoxicity of DMPC-NE was determined by Neutral Red Uptake (NRU) and 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) assays. Finally, the physical compatibility of the DMPC-NE with soft CL was tested by measuring the power, diameter, thickness and UV transmittance of two different types of CL.

Results: DMPC-NE had a mean particle size of 86.48 ± 4.22 nm, a polydispersity index of 0.22 ± 0.01 and a zeta potential of -33.23 ± 0.93 mV that remained with no changes after 24 months. DMPC-NE formulation, free of preservatives, showed no cytotoxicity and it was compatible with the physical properties of FDA-class II and -class IV CL.

Conclusion: DMPC-NE is a highly stable formulation for dry eye that is safe to be used while wearing soft CL.