Background: Oral inflammatory ulcers are one of common complaints of patients attending out-patient clinics. Previous in vivo studies had shown that an aqueous M. citrifolia fruit extract (AMFE) possessed anti-inflammatory and ulcer healing activities. Therefore, a standardized topical bioadhesive gel containing AMFE-phytosome was developed and determined for its oral ulcer healing efficacy in a rabbit model.

Methods: The AMFE phytosome (AMFE-P) was prepared by complexation method with the required amount of AMFE: Phosphatidylcholine: Tween 80 to weigh ratio of 2:1:0.2. Poloxamer 407 was used as a gelling agent. Oral ulcer was induced in male New Zealand white rabbits by topical application of acetic acid. Each test compound was applied to the ulcer for 10 days beginning on the second day after the ulcer induction. Complete ulcer healing on the specimen obtained on day 12 was observed histologically using the histological scoring protocol.

Results: The optimized gel containing AMFE-P equivalent to AMFE 10%w/w (10%AMFE-P gel) showed the best bioadhesive gel quality, a smooth and homogeneous texture with an optimum viscosity and pH range use in human oral cavity, a good physical and chemical stability and the highest percentage cumulative release of total phenolic and scopoletin content. It was found that a daily application of 10% AMFE-P gel exerted a superior ulcer healing efficacy and a significant more rapid ulcer healing process than a twice daily application of topical gel containing AMFE 10%w/w or chlorhexidine 0.2%.

Conclusion: These findings demonstrated that 10% AMFE-P gel has potential as a safe and effective alternative therapeutic agent for oral ulcers.

Keywords: AMFE.; Morinda citrifolia; chlorhexidine; oral ulcer; phytosome; scopoletin.