title: The evaluation of the local tolerance of vaginal formulations, with or without nonoxynol-9, using the slug mucosal irritation test.
abstract: BACKGROUND
  Frequent use of some vaginal formulations can induce mucosal irritation. Therefore, it is important to evaluate their vaginal tolerance.
  
  
  OBJECTIVE
  The goal of this study was to optimize the mucosal irritation test using slugs for the evaluation of the local tolerance of vaginal gels and investigate the relevance of the test.
  
  
  METHODS
  The irritation potential of the gels was assessed by the amount of mucus produced during a repeated 30-minute contact period. Membrane damage was estimated from the release of proteins and enzymes. After optimization of the procedure, the local tolerance of several vaginal gels was evaluated.
  
  
  RESULTS
  Hydroxyethyl cellulose gel induced no irritation, because the mucus production and the protein release were low and no enzyme release was detected. Replens and K-Y jelly resulted in an increased mucus production; however, no increased protein and no enzyme release were detected. The nonoxynol-9-containing gels Protectaid, Advantage S, and Conceptrol caused a higher mucus production and an increased protein release and/or enzyme release, indicating severe irritation.
  
  
  CONCLUSIONS
  The mucosal irritation test using slugs can be used for local tolerance testing of vaginal formulations.
authors.affiliation: Laboratory of Pharmaceutical Technology, Ghent University, Harelbekestraat, Ghent, Belgium.
authors.forename: Marijke M M
authors.initials: MM
authors.lastname: Dhondt
authors.forename: Els
authors.initials: E
authors.lastname: Adriaens
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Remon
mesh_terms: D000282:Administration, Intravaginal; D000818:Animals; D002626:Chemistry, Pharmaceutical; D004353:Drug Evaluation, Preclinical / Q000379:methods; D005260:Female; D006801:Humans; D008974:Mollusca / Q000187:drug effects / Q000502:physiology; D009092:Mucous Membrane / Q000187:drug effects*; D017137:Nonoxynol / Q000008:administration & dosage / Q000494:pharmacology*; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D013089:Spermatocidal Agents / Q000008:administration & dosage / Q000494:pharmacology*; D014622:Vaginal Creams, Foams, and Jellies / Q000008:administration & dosage / Q000494:pharmacology
chemical_list: D013089:Spermatocidal Agents; D014622:Vaginal Creams, Foams, and Jellies; D017137:Nonoxynol