DEVELOPMENT AND EVALUATION OF NANOBIOCOMPOSITE TOPICAL FORMULATION

Abstract

Objective: The proposed research involving transferosomes within a hydrogel matrix offers a promising approach for enhanced wound healing. This system aims to facilitate the dermal delivery of nanosized curcumin while incorporating Ascorbic acid and Salicylic acid. The integration of these components holds the potential for advancing chronic wound therapy. Methods: Curcumin transferosomes were formulated by the lipid thin film hydration method and further optimization was carried out using 32 full factorial design. The transferosome formulation, prepared using phospholipon 90G, involved selecting specific variables: the quantity of edge activator and sonication duration as independent factors, while the optimization process considered particle size and entrapment efficiency as dependent variables. Following the optimization of the transferosomes, a hydrogel formulation was developed using the central composite design approach. Results: Optimized transferosome (Batch F8) showed 87.75±3.74 nm (nanometer) particle size and 91.18±2.71% entrapment efficiency. Hydrogel was formulated by Central composite design, selecting pH and spreadability as dependent factors, to which was added curcumin transferosomes, Ascorbic acid and Salicylic acid. The data was analyzed using Stat-ease Design-Expert v7.0.0 software. The optimized batch F3 showed a pH of 6.84, spreadability of 12.89 gm. cm/sec and Curcumin release of 87.47%. Drug release from nanobiocomposite hydrogel was evaluated using the in vitro study of the formulation. The various kinetic models were applied to in vitro release data for the prediction of the drug release kinetic mechanism. The release constants were calculated from the slope of appropriate plots, and the regression coefficient (R2) was determined. It was found that the in vitro drug release of the formulation was best explained by Higuchi as the plots show the highest linearity. The regression coefficient (R2) was found to be 0.907, 0.9266 and 0.9536 for Ascorbic acid, Salicylic acid and Curcumin, respectively. Conclusion: The nanobiocomposite topical formulation was thus prepared, tested and for skin irritancy study. There is no noticeable signs of erythema, edema, or inflammation were observed on the skin. These results indicate that the developed transdermal formulation does not cause skin irritation and can be considered non-irritating.