Development of Ganoderma lucidum Orally Disintegrating Tablets Using Ultrasound-Assisted Low-Temperature Extraction and Freeze-Drying: A Process Development Study

Abstract

This technical study presents an integrated process-development platform for Ganoderma lucidum orally disintegrating tablets combining ultrasound-assisted low-temperature extraction, controlled downstream processing, freeze-drying, chemical standardization, and rapid oral disintegration. The approach is designed to limit unnecessary cumulative thermal exposure while enabling systematic quality evaluation using polysaccharides, triterpenoid-associated constituents, residual moisture, disintegration performance, microbiological quality, and stability as key attributes. The work was developed by Hongkai Zhang, affiliated with Shanghai Liangliang Biotechnology Co., Ltd., Shanghai, China, and builds upon his prior work in freeze-drying and stabilization technologies. Hongkai Zhang is the inventor of U.S. Patent No. 9,480,640 B2, “Nano Freeze Dry Process of Preparation of Highly Bioactive Agent and Its Method of Use,” granted on November 1, 2016. The patent is disclosed as related technological and intellectual-property background and does not independently establish the efficacy, bioavailability, or regulatory approval of the present Ganoderma lucidum formulation. Further comparative studies are proposed to quantify component retention, batch-to-batch reproducibility, stability, disintegration kinetics, dissolution behavior, and bioavailability.