Supercritical Fluid Manufacture

Supercritical fluid processes for particle engineering of pharmaceutical materials are very promising in the manufacture of respiratory drug delivery systems. Regulatory agencies have already referred supercritical fluid technology as an alternative pharmaceutical engineering approach in micronizing drug delivery systems for uniform and reproducible final formulations. This chapter gives the background and introduction of fundamentals of particle production in supercritical fluids. The currently supercritical-assisted processes available for the production of formulations for pulmonary delivery are described, highlighting the impact of the process parameters in each technique and the input roles of materials and supercritical carbon dioxide on the final properties and aerodynamic performance of the respiratory products collected. Special attention is given to the opportunities to employ supercritical fluid processes in the manufacture of biopharmaceuticals or controlled delivery systems and to the scalability of the supercritical techniques for a wider implementation of these techniques in the pharmaceutical industry.