RefluBaby the first sterile antireflux syrup without preservatives
RefluBaby is the antireflux syrup based on alginate, sterile without preservatives, in order to provide pediatric patients with a safer product.
Thanks to the technology developed in Bioitech, it has been possible to stabilize the alginate and the components present within the formulation, allowing the product to be sterilized by moist heat, without deterioration or loss of activity of the ingredients contained therein.
The mechanism of action of RefluBaby is due to the alginate, which in contact with the acidic contents of the stomach forms a plug, which occludes the cardia, preventing the gastric contents from rising.
Unlike other products containing pharmacological active ingredients, RefluBaby acts mechanically and therefore is absolutely safe for pediatric use.
Directive 2006/52 on the use of preservatives in children
With Directive 2006/52, the use of some preservatives, including propyl paraoxybenzoate, have been eliminated from food additives authorized for pediatric use.
Recent in vitro studies have led the EMA to issue a note advising against the use of propyl paraoxybenzoate in oral medications intended for children.
EMA/CHMP/SWP/272921/2012 22-10-2015
The problem of preservatives in syrups for continuous use
At 4 months, 70% of infants have episodes of gastroesophageal reflux with spontaneous resolution around 12-18 months. In a significant percentage of children with gastroesophageal reflux, symptoms can persist throughout adolescence through adulthood, so those with gastroesophageal reflux are often forced to use products containing paraoxybenzoates for long periods and multiple times. per day.
Gastro-esophageal Reflux in Children. Rybak A. et al. nt J Mol Sci 2017 Aug 1;18(8):1671.
REFLUX BABY IS A MEDICAL DEVICE
Patent filed n. 102021000029657
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