In vitro safety and performance evaluation of a seawater solution enriched with copper, hyaluronic acid, and eucalyptus for nasal lavage

Med Devices (Auckl). 2019 Sep 24:12:399-410. doi: 10.2147/MDER.S209644. eCollection 2019.

Abstract

Background: The common cold is a viral infectious disease with symptoms such as runny nose, sore throat, and mainly, nasal congestion. State-of-the-art therapeutic approaches focus on alleviating the symptoms of this disease by non-invasive and simple-to-use methods. Nasal irrigation is one of the most accepted approaches to ease nasal congestion which, if left untreated, has a negative impact on the quality of life of patients.

Purpose: In this study, the safety and efficacy of a novel hypertonic seawater solution for nasal lavage enriched with hyaluronic acids, eucalyptus oil, copper, and manganese salts (Stérimar Stop & Protect Cold and Flu; SSPCF) have been investigated in vitro.

Methods: An in vitro 3D reconstituted human nasal epithelium tissue model, MucilAir™, has been used in this study to investigate the safety of SSPCF on nasal epithelium by measuring transepithelial electrical resistance (TEER), lactate dehydrogenase (LDH), and interleukin-8 (IL-8) secretion. The efficacy of SSPCF was measured by mucociliary clearance (MCC), ATP release, Alcian blue and aquaporin (AQP3) stainings.

Results: SSPCF treatment respected nasal epithelium tissue integrity and enhanced barrier function without inducing a cytotoxic response. Secreted LDH and IL-8 levels were similar to untreated controls. MCC rate was increased 2.5-fold and ATP release decreased 87% upon SSPCF treatment, indicating improved decongestion activity. SSPCF treatment after hypotonic stress helped recover cellular organization, as shown by Alcian blue and AQP3 staining assays.

Conclusion: SSPCF appears as a safe and effective nasal irrigation formula that may alleviate the symptoms associated with common cold such as nasal congestion.

Keywords: ATP release; common cold; decongestion; hypertonic seawater; nasal irrigation; pathogens.