Evaluation of the Safety and Toxicological Profile of MucoLox: Human Oral Mucosa, Nasal Mucosa and Vaginal Mucosa (Part 2/3)

Introduction: The nasal cavity is a promising site for drug delivery as it is easily accessible to patients, has a large surface area (due to the presence of microvilli), contains a thin nasal epithelium, and it can bypass first-pass metabolism [1]. However, many conventional dosage forms (e.g. gels, solutions, suspensions) have low residence time (time at site of action) within the nasal cavity as these can be easily expelled from the application site with sneezing, as a result of mucociliary clearance, or by nasal drainage [2]. Mucoadhesive polymers are delivery systems developed to overcome these issues by increasing the adhesion between the polymer and the nasal mucus, inhibiting mucociliary clearance of the medication, and hence prolonging the residence time [1]. Due to the prolonged contact between the delivery system and the application site, it is important to evaluate the toxicity potential of these polymers on the nasal mucosa. This study was therefore designed to examine the safety and toxicological profile of MucoLox, a proprietary mucoadhesion polymer gel, using the EpiAirway tissue model (MatTek Corporation), a 3-dimensional (3D) model developed to closely resemble the structure and functionality of the human nasal mucosa [3, 4].