Combined application of extrusion-spheronization and hot-melt coating technologies for improving moisture-proofing of...

The aim of this research was to investigate the moisture-proofing effect and its mechanism for herbal extracts using extrusion-spheronization combined with hot-melt coating. Guizhi Fuling (GF) compound herbal extract with high hygroscopicity was used as a model drug. In the process of extrusion-spheronization, pellets containing 100% GF were prepared, and then coated with hot-melt coating material using a traditional coating pan. The moisture sorption data for GF were determined by storage at a series of different relative humidities. When the pellets were coated with a 96:4 mixture of stearic acid and polyethylene glycol 6000, the cumulative drug release was over 90% at 45 min while the moisture content was 4.9% at 75% RH within 10 days. These pellets have better moisture-proofing than those coated with Opadry AMB at the same coating level due to a different moisture sorption mechanism. The moisture sorption behavior of the hot-melt coating can be attributed to water vapor diffusion via a porous matrix system, while the Opadry AMB coating system involved a swelling controlled system. The Higuchi model was the best fit for the moisture sorption of the hot-melt coating in all formulations whereas the Opadry AMB coating fitted the Nuttanan model.