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What is the rationale for developing the product?
Nasal irrigation with saline solutions has been used for many years as a simple procedure to treat sinus and nasal conditions.'131 The flushing of the nasal cavity with saline solutions cleans the nasal passages of causes of inflammation and excess mucous, promotes ciliary function and decreases oedema.[2,4,5] In addition to sodium chloride, other minerals and trace elements also appear to play a role in the efficacy of nasal saline irrigation.'1,2,51 However, most generic saline solutions contain only water and sodium chloride, and most seawater-based formulations contain diluted seawater and, therefore, have a very low mineral content.121
Isotonic seawater nasal hygiene products (hydraSense®, Physiomer®, Rhinomer®) that contain minerals and trace elements have been developed from purified naturalsource Atlantic seawater. Selective electodialysis is used to reduce the sodium chloride content of the seawater, while perserving the original concentrations of other minerals and trace elements.'11
What does the product contain?
Isotonic seawater nasal hygiene products contain >80 different minerals and trace elements in concentrations generally similar to those present in natural seawater.'2,6 The presence of magnesium, sulfates and trace elements, such as iron, copper, magnesium, zinc and selenium (table I), are thought to provide these products with unique antiinflammatory and cell-repairing properties relative to other saline solutions.'2,3,61 In an in vitro study, isotonic seawater solution promoted respiratory epithelial cell growth and stimulated the metabolic activities of respiratory epithelial cells to a significantly (p < 0.0001) greater extent than seawater diluted by one-third and a traditional saline solution.[2]
The lower sodium concentration in isotonic seawater solution relative to that in normal saline solutions may have beneficial effects on nasal mucosal inflammation, as elevated sodium concentrations in human airway fluids may decrease antibacterial defences and increase inflammatory responses in respiratory tissues.'51 In an in vitro study,'51 the expression and secretion of the chemokine interleukin-8 in human respiratory epithelial cells was significantly (p <...