Evaluation of the Safety and Toxicological Profile of MucoLox: Human Oral Mucosa, Nasal Mucosa and Vaginal Mucosa (Part 1/3)

Introduction: The buccal mucosa, which contains non-keratinized epithelial cells lining the inner cheeks of the mouth, is a site for local and systemic delivery of medication. This region is highly vascularized and relatively immobile [1]. Buccal delivery allows for the active ingredients to exert rapid onset of action, bypassing liver first pass-metabolism, and avoiding pH fluctuations and degradation within the gastrointestinal tract [2]. Due to the small absorptive surface of the buccal mucosa, mucoadhesive polymers have been developed to prolong mucoadhesion and increase residence time (time at the site of action) [3]. Mucoadhesive polymers are often used to deliver medication for the treatment of local diseases and conditions of the oral mucosa such as mucositis (inflammation of the mucous membrane), ulcers, infections, and candidiasis [4]. The prolonged intimate contact between the delivery system and the tissue require these polymers to be non-irritating and non-toxic in order to minimize adverse effects and patient discomfort [2]. The purpose of this study is to evaluate the safety and toxicological profile of MucoLox, in comparison to Triton X-100 (positive control) and distilled water (negative control), using a 3-dimensional (3D) model of the human oral mucosa. MucoLox is a proprietary polymer gel that acts as a delivery system to improve mucoadhesion and prolong retention of medications at application sites within the oral mucosa [5]. Triton X-100 is a nonionic surfactant, not approved for oral use, used in this study as a positive control [6].