Efficacy and safety evaluation of a hypertonic seawater solution enriched with manganese and copper salts

Background: Nasal irrigation is commonly recommended as an adjuvant treatment for blocked nose. In the present study, the safety and efficacy profile of Stérimar Blocked Nose (SBN), a hypertonic seawater solution enriched with manganese and copper salts, has been evaluated on nasal epithelium, in vitro. Methodology: 3D reconstituted human nasal epithelium tissue model, MucilAir™, has been used to investigate the safety of SBN on nasal epithelium by measuring trans-epithelial electrical resistance (TEER), cytotoxicity (lactate dehydrogenase (LDH) release) and phlogosis-related effects (interleukin-8 secretion). Efficacy assessment was measured by ciliary beat frequency (CBF), mucociliary clearance (MCC) and antimicrobial activities (against Staphylococcus aureus and Pseudomonas aeruginosa). Results: Four-day SBN treatment did not compromise the nasal epithelium integrity as TEER values were over the tissue integrity limit. SBN treatment did not exert cytotoxic (LDH release) or pro-inflammatory effects (IL-8 secretion). SBN treatment significantly increased the CBF and MCC rates compared to untreated cells. SBN treatment exerted a bactericidal effect on S. aureus and P. aeruginosa cultures, whereas seawater not enriched in copper and manganese had only a bacteriostatic effect. Conclusions: The results demonstrate that SBN is a safe formula for use on human nasal epithelium. The results also suggest a better potential therapeutic role for SBN in comparison to not-enriched seawater when used to control nasal congestion and inhibit bacterial growth which may cause nasal congestion.