Abstract
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.
Highlights
Active pharmaceutical ingredients (APIs) are usually formulated into designed dosage forms before being administered to patients
SMS are widely prepared by various approaches to mitigate the solubility, stability, and manufacturability of the final drug form
Numerous studies have demonstrated that the supercritical anti-solvent (SAS) process can effectively produce desired SMS, especially the pharmaceutical co-crystals and solid dispersions
Summary
Active pharmaceutical ingredients (APIs) are usually formulated into designed dosage forms before being administered to patients. The solid-state properties of APIs play an important role in modifying their physicochemical properties [2,3]. It is paramount for the pharmaceutical industries to control accurately the solid-state properties of APIs during their manufacture, formulation and shelf life. The SMS development mainly focuses on the manipulation of the solid-state properties of APIs, such as the formation of salts, amorphous formulations, solvates, cocrystals, liquid crystals, and nano-cocrystals, to overcome problems of the final drug form, such as poor solubility and dissolution rate, hygroscopicity, poor tabletability, instability, and bitter taste [4,5]
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