Work

Quality by design optimization of microemulsions for topical delivery of Passiflora setacea seed oil

Year: 2025

Type: article

Abstract: Passiflora setacea seed oil is a natural source of bioactive unsaturated fatty acids, notably linoleic acid (ω-6) and oleic acid (ω-9), with promising antioxidant and anti-inflammatory potential for dermatological applications. However, its direct use is limited by poor physicochemical and organoleptic properties. This study aimed to develop and optimize a topical microemulsion (ME) system incorporating P. setacea seed oil using quality by design principles to address formulation challenges. The oil was extracted via Soxhlet and characterized by gas chromatography–mass spectrometry and thermal analysis. A full factorial design, followed by a Box–Behnken design, was employed to optimize the formulation based on critical quality attributes and the defined quality target product profile. The optimized ME presented a hydrodynamic diameter of approximately 22 nm and polydispersity index below 0.2 and remained stable for 60 days. The ME was gelled with sodium carboxymethyl cellulose, while vitamin E and Liquid Germall ® Plus were incorporated as antioxidant and preservative agents, respectively, yielding the final topical gel formulation. Cytocompatibility assays demonstrated high cell viability for ME at concentrations below 2 mg/mL in RAW 264.7 macrophages and 0.5 mg/mL in human umbilical vein endothelial cells. Overall, this work presents a promising nanotechnology-based topical delivery platform for P. setacea seed oil, employing quality by design principles to ensure formulation performance, stability, and skin cell compatibility.

Source: Beilstein Journal of Nanotechnology

DOI: 10.3762/bjnano.16.146