Analytical Method Validation and Formula Optimization of Topical Nanoemulsion Formulation Containing Resveratrol

Abstract

Resveratrol (RSV), a natural lipophilic phytoalexin, was reported as an antioxidant and anti-inflammatory agent, which has the potential to cure diabetic wounds. However, several studies suggested the limitation of RSV, such as poor aqueous solubility, poor stability, and poor oral bioavailability. To overcome the issues, RSV was formulated as a topical nanoemulsion. It is important to ensure the quality of the dosage form by evaluating RSV load in the nanoformulation and optimizing the formula. A reversed-phase HPLC method was developed and validated prior to the load determination of RSV in the nanoemulsion formulation. The composition of triacetin-eugenol, Kolliphor® RH 40, and Transcutol® was further optimized by employing a Box-Behnken Design (BBD) to achieve the optimum composition with expected viscosity and RSV load. The HPLC method for determining RSV load was successfully validated for parameters of selectivity with the resolution of 8.487, linearity and range (r = 0.9979), precision (0.12% of RSD), accuracy (109–110% of recovery), the limit of detection (0.574 µg/mL), and limit of quantitation (1.740 µg/mL). The result of formula optimization was promising, showing the optimum composition of triacetin-eugenol, Kolliphor® RH 40, and Transcutol® at 4.44 g, 30.97 g, and 11.39 g, respectively.

Novel Quercetin Nanoemulgel Optimization: Gelling Agents Evaluation and the Application of Response Surface Methodology

“…The system of surfactant in the nanoemulsion formulation is essential in establishing a stable and good quality of the emulsion. In the previous study [15], we confirmed that an adequate combination of surfactant and cosurfactant supports the micellization of the nanoemulsion in solubilizing the lipophilic compound, showed by the high transparency of resveratrol nanoemulsion. The characteristic of such nanoemulsion has made the formulation [15] is of choice in delivering the QUE topically to the wound effectively.…”

“…In the previous study [15], we confirmed that an adequate combination of surfactant and cosurfactant supports the micellization of the nanoemulsion in solubilizing the lipophilic compound, showed by the high transparency of resveratrol nanoemulsion. The characteristic of such nanoemulsion has made the formulation [15] is of choice in delivering the QUE topically to the wound effectively. Nevertheless, low viscosity, thus uncontrolled spreadability of nanoemulsion, may lead to the inconvenience of the application.…”

“…Principle component analysis (PCA) can be applied as the first endeavor in profiling the prime components of formulation based on the expected physical performance prior to formula optimization [21]. Formula optimization using Box Behnken Design (BBD) in association with response surface methodology allows the formulators to build a rigid design of experiment with less risks of trial and error, thus enhancing the efficiency in formula design [15,22]. Systematic formula optimization offers an excellent solution to establish the novel QUE nanoemulgels.…”