[The tolerability of nasal drugs with special regard to preservatives and physico-chemical parameters].
BACKGROUND
Recent technical developments allow preservative-free nasal drug application in multi-dose systems. New pharmaceutical formulations for better tolerable nasal sprays are now possible and consequently reformulations introduced to the market. Therefore, a representative and systematic overview on comparable products is mandatory.


METHODS
Marketed nasal products in the indication groups: decongestants, antiallergics, care and wound-healing, hormones and saline solutions were tested for their cytotoxic properties according to DIN EN 30 993 - 5, pH, and osmolality.


RESULTS
In all indication groups reformulation to preservative-free application resulted in significant increase of cell growth and reduction of cytotoxicity. Physico-chemical galenic properties are of considerable importance too. With decongestants tolerability is dependant on the concentration of the active compound.


CONCLUSIONS
Our data lead to the conclusion that preserved nasal sprays are obsolete, when preservative-free alternatives are available. Attention should be paid to galenic properties and dosage of the active.
Verse
Th
T
Universitäts-Hals-Nasen-Ohrenklinik Mannheim. thomas.verse@hno.ma.uni-heidelberg.de
Sikora
C
C
Rudolph
P
P
Klöcker
N
N
D000281:Administration, Intranasal; D000328:Adult; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000494:pharmacology* / Q000633:toxicity; D001548:Benzalkonium Compounds / Q000494:pharmacology / Q000633:toxicity; D002460:Cell Line; D002626:Chemistry, Pharmaceutical; D002648:Child; D003470:Culture Media; D006728:Hormones / Q000008:administration & dosage; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage / Q000494:pharmacology / Q000633:toxicity; D007223:Infant; D007231:Infant, Newborn; D009278:Naphazoline / Q000008:administration & dosage / Q000494:pharmacology / Q000633:toxicity; D014663:Nasal Decongestants / Q000008:administration & dosage / Q000494:pharmacology* / Q000633:toxicity; D009297:Nasal Mucosa / Q000166:cytology / Q000187:drug effects*; D009883:Ophthalmic Solutions / Q000008:administration & dosage / Q000494:pharmacology / Q000633:toxicity; D011310:Preservatives, Pharmaceutical; D012965:Sodium Chloride / Q000008:administration & dosage; D013997:Time Factors; D014945:Wound Healing
D018926:Anti-Allergic Agents; D001548:Benzalkonium Compounds; D003470:Culture Media; D006728:Hormones; D007093:Imidazoles; D014663:Nasal Decongestants; D009883:Ophthalmic Solutions; D011310:Preservatives, Pharmaceutical; D012965:Sodium Chloride; D009278:Naphazoline; C005810:tetrahydrozoline; C005370:tramazoline; C009695:xylometazoline