Diseño y caracterización de una formulación para comprimidos de PEUMUS BOLDUS mediante la aplicación de la técnica granulación seca activada por humedad (MADG Moisture actives dry granulation).

Abstract

The research was to design and characterize the formulation for Peumus boldus tablets through the application of the moisture-activated dry granulation technique (MADG), which was carried out in the Pharmaceutical Technology Laboratory of the School of Biochemistry and Pharmacy of the Polytechnic School of Chimborazo. With the application of the analytical method, 5 formulations were made, these being: Batches of solid dispersion 1:1, 1:2.5, 1:5, 1:5, physical mixture and placebo. The solid dispersions of alkaloids obtained at pH 8.5 were prepared by the dissolution method using Kollidon K-30® as polymer. The physicochemical properties of the formulations of solid dispersions, physical mixture and pure drug were investigated by phytochemical, spectroscopic (UV and IR) and chromatographic (TLC) techniques. The log P (total alkaloids) 0.84 indicated SCB as class II. Infrared spectra showed no drug-excipient interaction. The formulations with solid dispersions showed a higher aqueous solubility (40.86% more) than the pure drug, the increase being greater as the polymeric proportion increased. The batches formulated with higher content of Kollidon K-30® 5% showed a faster disintegration time, higher hardness, better dosage content. The quality parameters evaluated in all the formulations complied with the "USP-32" specifications, being LOT 3 (DS1:5) the one with the best results. The researcher is recommended to perform a final formulation and optimization of Peumus boldus tablets with the formulation of LOT 3 (DS1:5), in order to introduce this new formulation and technology.