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. 2007 Apr 27;8(2):E54–E60. doi: 10.1208/pt0802034

Eudragit E as excipient for production of granules and tablets from phyllanthus niruri L spray-dried extract

Tatiane Pereira de Souza 1,3, Ramón Martínez-Pacheco 2, José Luiz Gómez-Amoza 2, Pedro Ros Petrovick 3
PMCID: PMC2750373  PMID: 17915804

Abstract

The aim of this study was to investigate the feasibility of using Eudragit E as a granulating agent for a spray-dried extract fromPhyllanthus niruri to obtain tablets containing a high dose of this product. The granules were developed by wet granulation and contained 2.5%, 5.0%, and 10.0% Eudragit E in the final product concentration. The tablets were produced on a single-punch tablet press by direct compression of granules using 0.5% magnesium stearate as a lubricant. The tablets were elaborated following a 2×3 factorial design, where Eudragit E concentration and compression force were the in-dependent variables, and tensile strength and the extract release of the tablets were the dependent variables. All granules showed better technological properties than the spray-dried extract, including less moisture sorption. The characteristics of the granules were directly dependent on the proportion of Eudragit E in the formulation. In general, all tablets showed high mechanical resistance with less than 1% friability, less moisture sorption, and a slower extract release profile. The Eudragit E concentration and compression force of the tablets significantly influenced both dependent variables studied. In conclusion, Eudragit E was efficient as a granulating agent for the spray-dried extract, but additional studies are needed to further optimize the formuations in order to achieve less water sorption and improve the release of the extract from the tablets.

Keywords: Phyllanthus niruri, spray-dried extract, wet granulation, Eudragit E100, phytopharmaceuticals

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