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The orofacial mucous membrane is an appealing route for drug delivery to improve both systemic and local treatments. The aim of the present study was to develop an oral dental film loaded with curcumin hydrotropic solid dispersion for sustained drug delivery in the orofacial region. Compared to other dosage forms, films are the most elegant, palatable, and suitable systems for systemic mucosal drug delivery.
A hydrotropic solid dispersion technique utilizing 2 M sodium salicylate was developed to enhance the solubility of curcumin, addressing its poor water solubility. By forming a solid dispersion with a 1:4 ratio through solvent evaporation, the in-vitro physicochemical properties of the curcumin-loaded system were evaluated.
The utilization of sodium salicylate hydrotrope in a molecular dispersion significantly improved the solubility and bioavailability of curcumin. Subsequently, an oral dental film loaded with hydrotropic solid dispersion was developed using the solvent casting method with HPMC and gelatin as mucoadhesive polymers. Six different films were prepared using polymeric blends with HPMC and gelatin, which showed homogeneity, yellowish colour, and high drug content uniformity of 98.56 ± 3.24, with thickness ranging from 0.16 mm to 0.24 mm. The films exhibited excellent folding endurance and tensile strength for improved patient palatability. In-vitro studies demonstrated a significant enhancement in curcumin release, reaching a maximum of 94.66% over seven days in the presence of sodium salicylate hydrotrope, following first-order kinetics. An ex vivo permeation of Cur-F3 film had a significant effect on mucoadhesion.
Using hydrotropes in oral film formulation is a new and sustainable method for delivering clinically significant curcumin through the oral mucosa. As a result, it is recommended for use in the design of treatments for other dental diseases.
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