[The protective effect of dexpanthenol in nasal sprays. First results of cytotoxic and ciliary-toxic studies in vitro].
BACKGROUND
In Germany more than 60 million units of nasal decongestants are prescribed or sold over the counter. The cytotoxic and ciliary-toxic potential of alpha-sympathomimetic decongestants is well established. Furthermore, in many of the marketed products preservatives are added, predominantly benzalchonium-chloride, which can lead to a further alteration of cell- and ciliary function. Recently a protective effect of dexpanthenol was found for the human nasal mucosa. The objective of the present studies was to prove the hypothesis that dexpanthenol is able to neutralise the toxic effects of both alpha-sympathomimetic decongestants, in particular those of xylometazoline, and those of benzalconium-chloride. Therefore, systematic cytotoxic and ex vivo in vitro ciliary-toxic studies were performed.


METHODS
After exposition to xylometazoline in concentrations of 0.1 % and 0.05 %, the influence of dexpanthenol (5 %) and benzalconium-chloride (0,01 %) was assessed by determination of a) cell growth of FL-cells of human amnion origin, and b) ciliary beat frequency of human nasal mucosa. All tests were performed placebo-controlled.


RESULTS
Both hypotheses were confirmed. Dexpanthenol (5 %) reduces statistically significantly the concentration-dependent toxic effects of xylometazoline, and benzalchonium-cloride regarding cell growth and ciliary beat frequency (p < 0.001). The combination of xylometazoline with dexpanthenol, while benzalconium-chloride is eliminated, resulted in a further significant increase of cell growth and ciliary beat frequency (p < 0.001), similar to control.


CONCLUSIONS
The additive application of dexpanthenol (5 %) with nasal decongestants and/or with preserved nasal sprays seems to be able to reduce the cell- and ciliary-toxic effects of these substances.
Klöcker
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N
AUDIT Institute for Medical Services and Quality Assurance, Taunusstein.
Verse
T
T
Rudolph
P
P
D000281:Administration, Intranasal; D000336:Aerosols; D000650:Amnion; D001548:Benzalkonium Compounds / Q000633:toxicity; D002455:Cell Division / Q000187:drug effects*; D002460:Cell Line; D002470:Cell Survival / Q000187:drug effects*; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D006801:Humans; D007093:Imidazoles / Q000633:toxicity; D066298:In Vitro Techniques; D009079:Mucociliary Clearance / Q000187:drug effects*; D010205:Pantothenic Acid / Q000031:analogs & derivatives* / Q000633:toxicity*
D000336:Aerosols; D001548:Benzalkonium Compounds; D004338:Drug Combinations; D007093:Imidazoles; D010205:Pantothenic Acid; C007288:dexpanthenol; C009695:xylometazoline