In-situ fast-prepared mucoadhesive oral gel for palliative treatment of chemotherapy-induced mucositis: preparation, characterizations and pre-post study

Oral mucositis is a painful inflammation of mouth and throat mucosal tissues with or without lesions. Chemo and radiotherapy are the two main causes of oral mucositis which can limit nutritional intake of patients and interrupting the treatment. In this study we aimed to prepare the in-situ fast-prepared protective oromuco-adhesive hydrogel film to overcome the mucositis problems through human study in six chemotherapy patients with oral mucositis. The chosen G 2 hydrogel formulation constructed of Carbopol-934 and high-Mw chitosan at weight ratio of 1:0.1 with acceptable gel appearance and proper biotribological properties such as mean mucoadhesive strength of 0.048 mJ/cm 2 and mean residence time of 2.1 h, showed significant pain-reduction ( p -value 0.043) and improvement of swallowng comfort in pre-post study. The hydrogel can be in-situ prepared fast and immediately used to form a protective physical barrier on mouth surface which can efficiently reduce the symptoms in patients with mucositis. Graphical Abstract The protective oromuco-adhesive hydrogel film constructed of Carbopol-934 and digested chitosan with 1:0.1 weigh ratio with acceptable gel appearance and proper biotribological properties which the pre-post study resulted pain-reduction and swallowing-comfort in chemotherapy patients with oral mucositis. Highlights Preparation of in-situ oromuco-adhesive hydrogel biofilm constructed of Carbopol-934 and chitosan. Preparation of low, medium, and high molecular weight chitosan solutions by H 2 O 2 digestion method. Fabrication of different gel formulations based on fractional factorial design. Pre-post study for the assessment of pain-reduction and swallowing-comfort in patients with mucositis.