Abordagem baseada em Quality by Design (QbD) para desenvolvimento de microemulsão contendo óleo de Passiflora setacea

Abstract

Microemulsions are nanoscale systems, particularly between 10 and 100 nm, capable of carrying natural oils and improving their organoleptic characteristics. The fixed oil obtained from Passiflora setacea stands out among others for its composition rich in unsaturated fatty acids of the omega family, endowed with therapeutic potential, such as wound healing. Thus, the aim of this work was to use the ideals of Quality by Design for the development of a formulation based on microemulsified systems. Initially, the fixed oil from P. setacea seeds was extracted using the Soxhlet method and had its chemical composition characterized using Gas chromatography–mass spectrometry. Then, designs of experiments were used to identify the ideal composition of oil, surfactants, and ratio of surfactants in relation to hydrodynamic droplet diameter, polydispersity index and visual classification. The exploratory linear planning models were not significant, indicating the possible presence of curvature. The Box-Behnken design was satisfactory in predicting the influence of factors and their interactions, the model has r2 of 0.99, 0.91 and 0.97, for hydrodynamic diameter, polydispersity index and visual classification, respectively. Through the response surface and the desirability profile, it was possible to develop an optimized system, followed by its improvement for the topical route. These systems retained their physicochemical stability for 60 days, with a good prognosis to be further investigated for activity and toxicity.