Assessment of therapeutic effectiveness of developed colchicine transnovasomes in treatment of recurrent aphthous ulcer as monotherapy and combination therapy with platelet-rich plasma.

Objectives: Transnovasomes is a new exciting class of lipid-based nanovesicles. Colchicine (COL) is a hydrophilic natural alkaloid with anti-inflammatory features having oral administration and permeation defects. Recurrent Aphthous Ulcer (RAU) is the most prevalent disease of the oral mucosa suffering from lack of a particular and final preventative therapy. So, designing a prolonged and effective specialized delivery system for ulcer treatment is important.

Methods: Colchicine transnovasomes (COL-TNs) were prepared using surfactants (Span 60 & Span 80), free fatty acids (Oleic acid & Stearic acid), Cholesterol and Brij 58. COL-TNs were evaluated for their vesicle size (VS), polydispersity index (PDI), zeta potential (ZP), entrapment efficiency (EE%), and permeation after 12 h (Q).

Results: Values of VS, PDI, ZP, EE% and Q of the optimized formulation were 256.74 ± 11.2 nm, 0.322 ± 0.08, -43.3 ± 0.62, 85.35 ± 3.7% and 72.69 ± 5.84% respectively. Drug accumulation from the optimized formulation was ninefold greater than drug solution after 8 h. , COL-TNs formulation, alone or in combination with platelet-rich plasma (PRP), achieved complete healing of acetic-acid induced RAU restoring normal levels of assayed biomarkers and normal oral mucosa histological features .

Conclusions: COL-TNs can be used as a promising, safe, efficient treatment of RAU, as monotherapy or combination therapy with PRP.