Diseño, formulación y control de calidad de un fotoprotector a base de totumo (Crescentia cujete).

Abstract

The Sun's ultraviolet (UV) rays interact with skin cells causing a wide range of damage, from degenerative diseases to skin cancer. Given the serious consequences of solar radiation exposure, it is urgent to seek natural and sustainable alternatives to help protect the population. Therefore, the objective of this study was the design, formulation, and quality control of a sunscreen based on calabash tree (Crescentia cujete). For this purpose, the collection, conditioning, and quality control of the plant drug were carried out using gravimetric methods. Phytochemical screening was performed to qualitatively determine the secondary metabolites present in calabash leaves. The dry extract was obtained through maceration and subsequent concentration in a rotary evaporator. The determination of the in vitro sun protection factor (SPF) of the extract and formulation was conducted using the spectrophotometric method and Mansur equation. The formulations used permitted ingredients and within the limits established by the FDA. Subsequently, quality control of the formulations was performed, including microbiological analysis of the best-performing formulation, demonstrating its efficacy and safety at the topical level, and the label was prepared according to NTE INEN 2867: 2015 COSMETIC PRODUCTS. REQUIREMENTS. The results showed that the flavonoid content was 343.64 ± 0.05 mg QE/g extract. The photoprotective activity of the extract obtained significant values, with an SPF of 33.249 at 3000 ppm. Formulation 8 presented optimal characteristics, an SPF of 40, and met the acceptability limits established in the microbiological parameters. It is recommended to conduct complementary toxicity and genotoxicity studies to ensure the product's safety.