Obtenção de formas farmacêuticas tópicas para o tratamento de vulvovaginites, contendo extrato seco de Endopleura uchi (Huber) Cuatrecasas e óleo de Bertholletia excelsa H. B. K.

Abstract

Two very important plants of the Brazilian Amazon, Bertholletia excelsa H. B. K. (B. excelsa) and Endopleura uchi (Huber) Cuatrec. (E. uchi), have aroused the interest of the scientific community for the development of phytotherapics and phytocosmetics, due to the functional potential and wide use by traditional medicine. The aim of this research was to obtain two topical dosage forms containing dry extract of E. uchi and B. excelsa oil, aiming at the treatment and prevention of vulvovaginitis. In the characterization and quality control of plant raw materials, both presented indices adequate to those recommended by Brazilian legislation. At the stage of the technological studies, a factorial design was carried out to optimize and standardize the aqueous extraction solution (SE) of E. uchi, whose results demonstrated by determining the content of total polyphenols, total solids and bergenin, that the best extraction method was performed with 10% drug: solvent ratio (m/v) under decoction for 5 minutes. In order to verify possible technological differences (yield and humidity) of the dry extract (ES), without the addition of adjuvants, the SE drying was performed in two different equipments, the fluidized bed drying and the spray dryer. The most appropriate spouted bed, with an operating yield of 66.73% and an ES humidity of 4.16 g%. The ES showed activity against C. albicans (ATCC 90028), C. Krusei (ATCC 6258), C. parapsilosis (ATCC 90018) and C. tropicalis (ATCC 750). Nine liquid soap formulations and three cream formulations with different concentrations of ES E. uchi and B. excelsea oil were evaluated. In both cases only one formulation showed technological feasibility and both containing 2% ES and 2% oil. Analysis of antifungal activity showed that the formulations were most effective against C. krusei (liquid soap = 25 µg/mL IC50 and 50 µg/mL IC50 cream) and C. parapsilosis (25 µg/mL IC50 = liquid soap and 25 µg/ml IC50 cream). Both formulations were analyzed for 30 days for stability when stored at different temperatures (5 °C, 25 °C and 40 °C), including the icethaw cycle. The study revealed that the cream formulation was stable throughout the storage period, under all conditions tested, on the other hand, the liquid soap formulation showed some instabilities, indicating the need for more rigor and careful storage.