A novel oral film of carbomer/Poly(vinyl alcohol)/hydroxypropyl cellulose triple polymer loaded with Periplaneta Americana extract for enhancing the oral ulcer treatment

The liquid formulation of Periplaneta Americana extract (PAE) demonstrates significant efficacy in the treatment of oral ulcers. However, its limited ability to adhere to the oral cavity leads to a diminished therapeutic effect. This study aims to address this limitation by developing a Periplaneta Americana extract oral film (PAEOF) designed to extend the PAE ‘s duration of action through enhanced adhesion. Utilizing a one-factor analysis approach, the optimal oral film incorporating Periplaneta Americana extracts , based on polyvinyl alcohol, hydroxypropyl cellulose, and carbomer, was developed. The resulting oral film exhibited an elongation at break of 548.86 ± 279.78 % and an adhesive force of 2.34 ± 0.47 N/cm 2 . Furthermore, the mucoadhesion time of PAEOF was quantified at 89.00 ± 2.83 min, demonstrating favorable bioadhesion properties. Pharmacodynamic studies in Sprague-Dawley rats revealed that the high PAEOF group, containing 20 % Periplaneta Americana extract , exhibited the most significant healing effect. After 5 days of administration, ulcer areas decreased from 52.43 ± 10.53 mm 2 to 16.92 ± 2.33 mm 2 , and ulcer burning points decreased from 10.00 ± 0.00 to 4.00 ± 1.46. Additionally, levels of various biomarkers including SOD (superoxide dismutase), TNF-α (tumor necrosis factor alpha), IL-6 (interleukin 6), IL-2 (interleukin 2), and IFN-γ (interferon gamma) in the PAEOF-treated groups approached those found in the healthy group, indicating a satisfactory therapeutic effect. In conclusion, PAEOF presents a novel approach for the treatment of oral ulcer diseases, offering enhanced adhesion and prolonged therapeutic efficacy.