Desenvolvimento de forma sólida obtida a partir de extrato seco de Schinopsis brasiliensis Engler

Abstract

The drying extract of medicinal plants, obtained by spray drying is the starting point of development of herbal medicines. They exhibit good chemical stability, lower microbiological contamination and de possibility of application in the order dosage forms. For development of a dosage form, the active ingredient from previous trial are needed aiming to foresee and possible incompatibility that may affect the final product. Thus, the pre-formulation studies is an important step in pharmaceutics development since it identifies, among other characteristics, related to the excipient problems as well as the stability of the formulation. Thus, the objective of this work was the development of a solid dosage for from the drying extract of Schinopis brasiliensis Engler. The extract was dried by spray-drying was produced from de hydroalcoholic extract of bark of S. brasiliensis (BRCA). The compatibility study was performed using different excipients (starch, microcrystalline cellulose 101 and 102, lactose. magnesium stearate, PVP K-30 and talc) from different analytical techniques associated with chemometric tools. Kinetcs studies were also performed using isothermal thermogravimetry and determination and validation method for major polyphenol by high performance liquid chromatography UV-Vis (HPLC UV-Vis). The results of optical microscopy, differential scanning calorimetric (DSC) and chemometric analyze indicate possible incompatibility with starch, lactose and magnesium stearate, which were confirmed by X-ray diffraction (DRX). The proposed formulation was more stable than the drying extract and good self time. The extract also showed a high concentration of polyphenol, and we opted for gallic acid, which has several pharmacological activities such as chemical marker. The development method showed good precision, accuracy linearity and limits of detection and quantification acceptable. The results indicate that the analytical techniques used in the preformulation studies of the drying extract and that it can be used for the development of capsules and tables if S. brasiliensis.