Background:
Oral inflammatory ulcers are one of the 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 a 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. The 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 used 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 significantly 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.