Zein, as one of the natural and GRAS proteins in plant, is renewable, nontoxic, biocompatible and biodegradable. Over the past decade, many research efforts have been devoted to zein-based biomaterials for several industrial applications. Combining with research experiences in our research group, the preparation methods, characterizations and pharmaceutical applications of zein-based nanoparticles were summarized in this review. Zein NPs with different particle nanostructures have been prepared by chemical crosslinking, desolvating, dispersing and micromixing strategies. The pharmaceutical applications of zein NPs are mainly focus on the drug delivery. Zein NPs can improve the drug stability, increase the oral bioavailability, control the drug release and enhance the drug targeting, thereby improving the pharmaceutical effect effectively. More efforts are required to analyze the relationship among preparation methods, particle nanostructures and pharmaceutical properties in virtue of quality by design approach, and further promote the scale-up production and clinical application of zein NPs.

Solid multicomponent systems (SMS) are gaining an increasingly important role in the pharmaceutical industry, to improve the physicochemical properties of active pharmaceutical ingredients (APIs). In recent years, various processes have been employed for SMS manufacturing. Control of the particle solid-state properties, such as size, morphology, and crystal form is required to optimize the SMS formulation. By utilizing the unique and tunable properties of supercritical fluids, supercritical anti-solvent (SAS) process holds great promise for the manipulation of the solid-state properties of APIs. The SAS techniques have been developed from batch to continuous mode. Their applications in SMS preparation are summarized in this review. Many pharmaceutical co-crystals and solid dispersions have been successfully produced via the SAS process, where the solid-state properties of APIs can be well designed by controlling the operating parameters. The underlying mechanisms on the manipulation of solid-state properties are discussed, with the help of on-line monitoring and computational techniques. With continuous researching, SAS process will give a large contribution to the scalable and continuous manufacturing of desired SMS in the near future.