Contribution to the Use of Annatto Oil in the Development of Phytomedicines: Evaluation of the Acute Oral Toxicity of Annatto Oil and Characterization of Carbopol Gels Containing Lipid Nanocarriers and the Unsaponifiable Fraction of Annatto
Bixa orellana L.; Nanostructured Lipid Carriers (NLCs); Topical Gels; Fractions; Oral Toxicity.
Bixa orellana L. (urucum) has been highlighted in research aiming to develop herbal medicines due to its wound-healing properties, mainly attributed to various compounds with antiinflammatory and antioxidant action, which favor tissue regeneration. With a view to contributing to the safety of future patients, this work evaluated the acute oral toxicity of formulations with nanoencapsulated urucum oil in Nanostructured Lipid Carriers (NLCs). Additionally, carbopol-based gels containing the NLCs with the unsaponifiable fraction of encapsulated urucum were developed for possible topical application. No behavioral, hematological, or biochemical changes, nor changes in body or organ weights, were found in acute oral toxicity tests in Wistar rats at a dose of 2000mg/kg of the oil. The NLC formulations showed average particle sizes between 106 and 161 nm, a Polydispersity Index (PDI) lower than 0.2, and a zeta potential up to -18 mV, indicating good stability for 90 days. HPLC analysis indicated the presence of tocotrienol in the unsaponifiable fraction of urucum, with a coefficient of determination (R²) of 0.9997, highlighting the adequacy of the model for quantifying the compound in the sample. The formulated hydrogels showed a stable appearance, skincompatible pH, and excellent spreadability, especially in formulations with the unsaponifiable fraction of urucum. Through the collected data, it was possible to confirm that the formulations are safe, stable, and promising for pharmaceutical use, with emphasis on potential topical and wound-healing applications.