PLoS ONE (Jan 2018)
Dissolution and uniformity of content of tablets developed with extract of Ximenia americana L.
Abstract
Herbal medicines currently represent an important part of the world pharmaceutical market, which shows growing interest in the use of herbal medicines. However, the production of such medicines involves a complex series of steps, which determine the production viability and the quality of the final product. Ximenia americana L. is a plant occurring in several regions of the world, with well-known and applied medicinal properties. Thus, the aim of this work was to develop and evaluate the physical and physical-chemical quality of tablets produced with X. americana L. extract. The extract was spray-dried from a hydroethanolic extractive solution and characterized as to its phytochemical composition. The chemical marker was determined and quantified using validated chromatographic methods. These methods indicated the presence of gallic acid at a concentration of 1.61 mg g(-1). Formulations were proposed and analyzed for their flow and compaction properties. The best formulation was used to obtain a batch of tablets, which was evaluated for its quality characteristics and showed to be within the pharmacopoeial specifications for average weight, hardness, friability, and disintegration time. The dissolution profile of the tablets produced was obtained, showing the release of about 70% of the vegetable extract content within 30 minutes. Results showed that it was possible to obtain herbal tablets containing a high content of vegetal extract by direct compression, developing a rapid process of formulation and production and guaranteeing the quality characteristics of the final product.