Evaluation of the Safety and Toxicological Profile of MucoLox: Human Oral Mucosa, Nasal Mucosa and Vaginal Mucosa (Part 3/3)

Introduction: Vaginal delivery of medication is advantageous in allowing for the medication to avoid first-pass metabolism and gastrointestinal degradation [1]. Lined with non-cornified, stratified squamous epithelium, the vaginal mucosa offers a large surface area and rich blood supply, making it a promising site for delivery of medication in the treatment of conditions such as vaginitis (inflammation), bacterial, fungal, and viral infections. The vagina has self-cleansing potential with large secretions of vaginal fluid, often limiting the residence time (time at the site of action) of conventional vaginal dosage forms such as tablets, creams, gels, and foams. For this reason, the use of mucoadhesive polymers as a delivery system is preferred. Mucoadhesive polymers can prevent leakage by prolonging the contact time between the medication and the mucosal tissue. Due to the prolonged contact with the vaginal mucosa, an ideal mucoadhesive polymer should be non-toxic and non-irritating [2]. The aim of this study was to evaluate the safety and toxicological profile of MucoLox, in comparison to that of Triton X-100 (positive control), using a 3-dimensional (3D) model of the human vaginal mucosa. MucoLox is a proprietary polymer gel designed to improve mucoadhesion and prolong retention of medication at application sites within the vaginal mucosa [3]. Triton X-100, which served as a positive control in this study, is a nonionic surfactant that can be used as a solubilizer, stabilizer, and emulsifier [4].