Evaluation of compatibility between Schinopsis brasiliensis Engler extract and pharmaceutical excipients using analytical techniques associated with chemometric tools

Abstract

Compatibility studies comprise an important step in pre-formulation since they allow the identification of the excipients most compatible with herbal extracts from different analytical techniques. The objective of this work is to evaluate the compatibility between the nebulized extract of S. brasiliensis Engler with pharmaceutical excipients using analytical techniques associated with chemometric tools. The extract was nebulized through aspersion and produced from the hydroalcoholic extract of the bark of S. brasiliensis Engler. Binary mixtures were produced in various proportions using the following pharmaceutical excipients: starch, microcrystalline cellulose (Avicel® 101 and 102), lactose, magnesium stearate, PVP K-30 and talc. The samples were analyzed by optical microscopy, differential scanning calorimetry and X-ray diffraction (XRD). With the data obtained from DSC curves, matrices for hierarchical cluster analysis (HCA) and principal component analysis (PCA) were made. Using microscopy, an amorphous formation and/or crystalline components could be seen. In DSC curves, as well as in PCA and HCA analyses, possible interactions were identified with starch, lactose and magnesium stearate. This was confirmed by XRD. The starch showed the greatest interaction. The results indicate that the DSC technique associated with chemometric tools contributed to a better interpretation of compatibility studies and that microcrystalline cellulose, PVP K-30 and talc were the most compatible excipients in relation to the extract.