Moisture-Proof Herbal Extract Pellets Prepared via Asymmetric Liquid Layering Technology Combined with Mesoporous...

The strong hygroscopicity of herbal extracts poses significant challenges for their formulation into stable solid dosage forms. In this study, Wang Bi (WB) extract pellets with enhanced moisture resistance were developed using asymmetric liquid layering (ALL) technology combined with mesoporous silica (MS) and magnesium stearate (Mg-st). This approach effectively isolates the pellets from ambient moisture, thereby improving their resistance to water vapor. Pellets containing 89.18% WB extracts were comprehensively characterized. Surface-modified pellets (SMs) prepared via ALL exhibited notable differences in texture, size, and sphericity compared with commercial pellets (CMs) produced by rotary granulation and polymer film coating. Hygroscopicity was evaluated by measuring weight changes under high relative humidity conditions. These morphological changes resulted in significant performance enhancement, with the hygroscopicity reduced to 1.94% after 10 days at 75% relative humidity, corresponding to approximately 25% of that measured for CMs. Moreover, the preparation process and excipients employed did not affect the release profile of the WB extracts. Collectively, these findings demonstrate that the combination of ALL technology with MS and Mg-st represents an effective strategy to enhance moisture resistance, offering a novel means to improve the stability and quality of traditional Chinese medicine formulations.