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SAFETY STUDY OF AN ANTIMICROBIAL PEPTIDE LACTOCIN 160, PRODUCED BY THE VAGINAL LACTOBACILLUS RHAMNOSUS.

Dover1,2, S.E., Aroutcheva3,4, A.A., Faro5, S., and Chikindas2,4, M.L. 1School of Biotechnology, The Royal Institute of Technology, 100 44 Stockholm, Sweden. 2Rutgers, The State University of New Jersey, New Brunswick, NJ 08901-8520, USA. 3Rush Medical Center, Chicago, IL 60612, USA. 4Health Promoting Naturals, Inc., Highland Park, NJ 08904, USA. 5The Women’s Hospital of Texas, Houston, TX 77054, USA.
Abstract

This study by researchers at the Royal Institute of Technology (Sweden), Rutgers University, Rush Medical Center, Health Promoting Naturals, Inc., and The Women’s Hospital of Texas demonstrated the ability to use MatTek’s EpiVaginal in vitro human organotypic vaginal-ectocervical tissue model to determine the irritation potential of an antimicrobial peptide. Purpose: To evaluate the safety of the antimicrobial peptide, lactocin 160. Methods: Lactocin 160, a product of vaginal probiotic Lactobacillus rhamnosus 160 was evaluated for toxicity and irritation. An in vitro human organotypic vaginal-ectocervical tissue model (EpiVaginal) was employed for the safety testing by determining the exposure time to reduce tissue viability to 50% (ET-50). Hemolytic activity of lactocin 160 was tested using 8% of human erythrocyte suspension. Susceptibility of lactobacilli to lactocin 160 was also studied. Rabbit vaginal irritation (RVI) model was used for an in vivo safety evaluation. Results: The ET-50 value was 17.5 hours for lactocin 160 (4.9 hours for nonoxynol 9, N9). Hemolytic activity of lactocin 160 was 8.2% (N9 caused total hemolysis). Lactobacilli resisted to high concentrations of peptide preparation. The RVI model revealed slight vaginal irritation. An average irritation index grade was evaluated as “none.” Conclusions: Lactocin 160 showed minimal irritation and has a good potential for intra-vaginal application.

Keywords

Anti-microbial, Anti-microbial peptide, Antimicrobial, Antimicrobial peptide, EpiVaginal, Hemolysis, Hemolytic activity, In vitro human organotypic vaginal-ectocervical tissue model, In vivo safety evaluation, Intra-vaginal applications, Lactobacilli, Lactobacillus rhamnosus 160, Lactocin 160, Rabbit vaginal irritation (RVI) model, Time to reduce tissue viability to 50% (ET-50)

Materials Tested

4% miconazole nitrate, 4% nonoxynol-9, Bacteriocin, Conceptrol, Lactocin 160, Monistat-3, Nonoxynol-9

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