title: Antimicrobial safety of a preservative-free nasal multiple-dose drug administration system.
abstract: Recent technical developments in metered-dose pumps allow preservative-free nasal drug application with multiple-dose systems, avoiding the cytotoxic and allergic problems of preservatives. The use of the 3K System as a representative of those systems is demonstrated as microbiologically safe and without risk for the user and for the product during shelf life, under challenge up to 24 weeks, as well as under worst-case conditions with heavy bacterial contamination on the outlet surface. Therefore, the authors assess preservative-free pump systems as the new gold standard for mucosal drug application.
authors.affiliation: AUDIT Institute for Medical Services and Quality Assurance, Taunusstein, Germany.
authors.forename: Norbert
authors.initials: N
authors.lastname: Klöcker
authors.forename: Axel
authors.initials: A
authors.lastname: Kramer
authors.forename: Thomas
authors.initials: T
authors.lastname: Verse
authors.forename: Claudia
authors.initials: C
authors.lastname: Sikora
authors.forename: Peter
authors.initials: P
authors.lastname: Rudolph
authors.forename: Georg
authors.initials: G
authors.lastname: Daeschlein
mesh_terms: D000281:Administration, Intranasal; D000890:Anti-Infective Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D036501:Metered Dose Inhalers / Q000009:adverse effects* / Q000592:standards*; D011310:Preservatives, Pharmaceutical / Q000008:administration & dosage / Q000009:adverse effects; D011550:Pseudomonas aeruginosa / Q000187:drug effects / Q000254:growth & development
chemical_list: D000890:Anti-Infective Agents; D011310:Preservatives, Pharmaceutical