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Vaginal irritation

1032

Qualification of a non-animal vaginal irritation method admitted as nonclinical assessment model (NAM) in the Incubator Phase of the United States Food and Drug Administration (US FDA) Medical Devices Development Tool (MDDT)

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) classifies personal lubricants as Class II medical devices. Because of this status and the nature of body contact common to personal lubricants, CDRH reviewers routinely recommend a standard biocompatibility testing battery that includes: an in vivo rabbit vaginal irritation (RVI) test; […]
1017

Production and characterization of a human antisperm monoclonal antibody against CD52g for topical contraception in women

Approximately 40% of human pregnancies are unintended, indicating a need for more acceptable effective contraception methods. New antibody production systems make it possible to manufacture reagent-grade human monoclonal antibodies (mAbs) for clinical use. We used the Nicotiana platform to produce a human antisperm mAb and tested its efficacy for on-demand topical contraception.
1016

Toxicity Assessment of Resveratrol Liposomes-in-Hydrogel Delivery System by EpiVaginal™ Tissue Model

The natural polyphenol resveratrol (RES) has shown great potential as an antimicrobial, including against microbes associated with vaginal infections. To fully exploit the activities of RES, an all-natural ingredients formulation for RES delivery at vaginal site has been developed, namely liposomes loaded with RES, incorporated into a chitosan hydrogel as secondary vehicle. Although considered non-toxic […]
999

Safety assessment scheme for menstrual cups and application for the evaluation of a menstrual cup comprised of medical grade silicone

Background Ensuring menstrual cup safety is paramount, yet a menstrual cup safety assessment scheme is lacking. This paper presents a quadripartite scheme, showing how it can be applied. Methods The Tampax Menstrual Cup was evaluated in the safety assessment scheme: (1) Biocompatibility and chemical safety of cup constituents. Extractables were obtained under different use condition; […]
973

In vitro -in vivo assay validation for vaginal irritation of chemicals

 The goal of the study is to validate the utility of the 3D human in vitro vaginal tissue model as an alternate for rabbit vaginal irritation using a set of coded test articles (TAs). A double-blinded study was conducted in which the investigator and the animal testing facility were provided with N=14 coded TAs and […]
841

Hyperosmolal vaginal lubricants markedly reduce epithelial barrier properties in a three-dimensional vaginal epithelium model

Most of the widely used vaginal lubricants in the U.S. and Europe are strongly hyperosmolal, formulated with high concentrations of glycerol, propylene glycol, polyquaternary compounds or other ingredients that make these lubricants 4 to 30 times the osmolality of healthy vaginal fluid. Hyperosmolal formulations have been shown to cause marked toxicity to human colorectal epithelia in vivo, and […]
699

ASSESSMENT OF AN IN VITRO HUMAN VAGINAL EPITHELIAL MODEL FOR PREDICTING VAGINAL IRRITATION.

Currently, the vaginal irritation potential of chemical ingredients and finished products is assessed using the in vivo rabbit irritation model. A viable in vitro method would be of great value to the personal care industry. In this study, the EpiVaginal™ reconstructed human epithelial model was evaluated for its ability to predict vaginal irritation of six […]
611

IN VITRO ASSESSMENT OF PERSONAL CARE PRODUCTS FOR VAGINAL IRRITATION USING 3D TISSUE CONSTRUCTS.

Three dimensional (3D) human vaginal-ectocervical tissue constructs may be a relevant in vitro model to rapidly screen for vaginal mucosal irritation potential of raw materials and final formulations. Here we report results from a study with an in vitro vaginal tissue construct (EpiVaginal™ from Mattek Corporation, USA), used to predict irritation responses of a variety […]