Propolgemma Orally Dispersible Tablets Children

The model consists of an inclined plane with or without a mucin lining. The product is made to run down the incline plane without mucin and with mucin. As can be seen in the graph, the adhesion time of the Propolgemma multifraction extract is 43% greater for the plane lined with mucin compared to the plane without mucin. This is additional evidence of physical and chemical interaction with mucopolysaccharides:

The objective of the test is to evaluate the in vitro adhesion of the Propolgemma Medical Device to a suitable cell model, using buccal cells, and subsequently determine how long the bioadhesion resists the flow of an artificial salivary solution. The graph shows that per cent adhesion of Propolgemma extracts exceeds that of Propolis extracts, both in the case of dilution (1:5) and after washing with artificial salivary solution. In light of the results obtained, it can be stated that the product, having demonstrated a good level of mucoadhesion and resistance, can provide an interesting protective effect for the oropharyngeal mucosa.

Resins and polysaccharides certainly have good mucoadhesive properties; however, it is important for antioxidant compounds, flavonoids for example, to also remain attached to the mucosal surfaces of the oropharyngeal cavity. An additional cell model was therefore developed (human pharyngeal cells on an inclined plane made with inert plastic material). In this model the Propolgemma multifraction extract is made to run down an inclined plane of inert plastic material, then down the same plane covered with human pharyngeal cells. The absorbance (UV-VIS) of the product that adheres to the plane, without cells and with cells, is measured (being sure to account for autofluorescence). Absorbance increases significantly when cells are present, a sign that the product has a special affinity for the biological substrate. In addition, a spike is clearly seen in the area of absorbance related to flavonoids (pinocembrin), a sign that these clearly adhere to the substrate.

In this specific in vitro test the secretion of inflammatory cytokines was observed in a primary human fibroblast cell line (sensitive cells that are ubiquitous in the skin and mucosae) exposed to lipopolysaccharide, a known inflammatory agent. When Propolgemma products position themselves between fibroblasts and LPS there is a reduction in the secretion of IL-6 (a known inflammatory cytokine) compared to a positive control (exposure to LPS only). In the experimental model the product was not applied to the cells directly but to a specific porous layer. This is important since the reduced inflammatory response can only be attributed to the barrier effect, therefore to a non-pharmacological, mechanical mechanism of action, and not to other possible forms of interaction with the fibroblasts. A 40-60% reduction in the inflammatory response was noted for the various products.

Propolgemma medical devices show an interesting dispersal effect on the bacterial biofilm formed by S. pyogenes, which can be attributed to a “mechanical” non-pharmacological mechanism. The model studied uses product concentrations below the minimum inhibitory concentration (MIC) to rule out a direct antiseptic effect. Propolgemma medical devices had a 30-35% greater dispersal effect on the preformed biofilm compared to the untreated control as shown in the figure. In another model, the products also showed an approximately 20% greater tendency to obstruct the formation of biofilm compared to the untreated control.