New phytopharmaceutical formulations: Development and characterization of tablets containing the aerial part of the plant pulverized and the soft extract from Bidens pilosa standardized on rutin

Background: Bidens pilosa, popularly known as black jack, has high interest as a medicinal plant. A large part of its biological activities are attributed to their constitution in predominance by secondary metabolites such as the flavonoids, like rutin. Objective: The aim of the present study was to obtain oral solid dosage forms (tablets) containing the aerial part of the plant pulverized and soft extract of B. pilosa standardized on rutin, as well as the validation of an analytical method for determination of the rutin content of the powder, soft extract and of the tablets. Materials and Methods: The liquid extract from B. pilosa was obtained by percolation and concentrated until it became a soft extract. An analytical method, by high-performance liquid chromatography, was validated for the quantification of rutin in the soft extract. Tablets containing the aerial part of the plant pulverized and the soft extract of B. pilosa quantified on rutin was obtained and characterized. After, the method for quantification of rutin on the tablets was covalidated. Results: The rutin content in the raw material was 0.71% (m/m), while in the soft extract was 7.29% (m/m). The dissolution efficiency of the tablets was significantly higher, for both formulations in the pH 6.8 medium compared to medium with pH 1.2. Pilot tablets PH and SE presented results above of that recommended after 120 days. Conclusion: Pilot tablets SE, with soft extract, presented higher content of rutin than pilot tablets PH, with powder of the aerial part from raw material. This new phytopharmaceuticals formulation proved to be promising to be a strategy to carry out the active principles of B. pilosa .