| Title | [The tolerability of nasal drugs with special regard to preservatives and physico-chemical parameters] | | Author(s) | Verse T, Sikora C, Rudolph P, Klöcker N | | Institution | Universitäts-Hals-Nasen-Ohrenklinik Mannheim. thomas.verse@hno.ma.uni-heidelberg.de | | Source | Laryngorhinootologie 2003 Nov; 82(11):782-9. | | MeSH | Administration, Intranasal
Adult
Anti-Allergic Agents
Benzalkonium Compounds
Cell Line
Chemistry, Pharmaceutical
Child
Comparative Study
Culture Media
English Abstract
Hormones
Humans
Imidazoles
Infant
Infant, Newborn
Naphazoline
Nasal Decongestants
Nasal Mucosa
Ophthalmic Solutions
Preservatives, Pharmaceutical
Sodium Chloride
Time Factors
Wound Healing
| | Abstract | 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. | | Language | ger | | Pub Type(s) | Journal Article
| | PubMed ID | 14634896 |
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