Medical Devices: Evidence and Research (Sep 2019)
In vitro safety and performance evaluation of a seawater solution enriched with copper, hyaluronic acid, and eucalyptus for nasal lavage
Abstract
Song Huang,1 Samuel Constant,1 Barbara De Servi,2 Marisa Meloni,2 Josip Culig,3 Marco Bertini,4 Amina Saaid5 1Epithelix, Geneva, Switzerland; 2Department of in Vitro Research, VitroScreen, Milan, 20149, Italy; 3Department of Pharmacology, University of Applied Health Sciences, Zagreb, 10000, Croatia; 4R&D Department, Laboratori Baldacci SpA, Pisa, Italy; 5Department of R&D and Innovation, Laboratoire Fumouze, Levallois-Perret, 92686, FranceCorrespondence: Marco BertiniLaboratori Baldacci SpA, Via S. Michele degli Scalzi, 73, 56124 Pisa, ItalyTel +39 5 031 3271Fax +39 5 057 0170Email [email protected]: 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: common cold, hypertonic seawater, nasal irrigation, pathogens, ATP release, decongestion
