title: Preclinical Evaluation of Tolerability of a Selective, Bacteriostatic, Locally Active Vaginal Formulation.
abstract: BACKGROUND
  Polybactum (Effik International, Brussels, Belgium) is a vaginal mucoadhesive product (medical device) designed to form a film that acts as a mechanical barrier with the aim of inhibiting colonization by specific pathogens. It contains polycarbophil, a bioadhesive agent, and lauryl glucoside (LG), a nonionic surfactant that reinforces the barrier effect through its tensioactive properties.
  
  
  OBJECTIVE
  To assess the local safety profile, tolerability, and efficacy of Polybactum formulations.
  
  
  METHODS
  The following studies were performed on 3 Polybactum formulations: 2 ovules (Type 1: LG 0.04% and Type 2: LG 0.1%) and 1 gel formulation. Bacteriologic tests assessing the effects on normal vaginal flora and pathogens; in vitro and in vivo tests designed to assess cytotoxicity, as well as irritant and sensitizing potentials; biocompatibility, barrier, residence time, and absorption tests using reconstituted human vaginal epithelium were performed.
  
  
  RESULTS
  Polybactum is a selective bacteriostatic agent that is active againstStreptococcus agalactiaeandGardnerella vaginaliswhile sparing normal vaginal flora; that is,Lactobacillusspp. It had no cytotoxic, irritant, and sensitizing effects nor did it impair barrier and fence functions of the vaginal epithelium. The Type 1 ovule showed film-forming properties in vitro. Finally, LG absorption through reconstituted human vaginal epithelium was negligible, ruling out the risk for possible systemic toxicity.
  
  
  CONCLUSIONS
  This favorable preclinical profile is encouraging and supports clinical studies on Polybactum Type 1 ovules for the prevention and management of recurring bacterial vaginosis.
authors.affiliation: Effik Italia S.p.A., Cinisello Balsamo, Italy.
authors.forename: Luca Ivan
authors.initials: LI
authors.lastname: Ardolino
authors.affiliation: VitroScreen Srl, Milan, Italy.
authors.forename: Marisa
authors.initials: M
authors.lastname: Meloni
authors.affiliation: Studio Brugali Food & Chemical Consulting, Almenno S. Salvatore, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Brugali
authors.affiliation: Laboratory of Toxicology, DiSFeB, Università degli Studi di Milano, Milan, Italy.
authors.forename: Emanuela
authors.initials: E
authors.lastname: Corsini
authors.affiliation: Laboratory of Toxicology, DiSFeB, Università degli Studi di Milano, Milan, Italy.
authors.forename: Corrado Lodovico
authors.initials: CL
authors.lastname: Galli
keywords: Streptococcus agalactiae; bacterial vaginosis; bacteriostatic agent; lauryl glucoside; polycarbophil; pregnancy infectious complications