Advanced Troubleshooting for Spray Drying of Pharmaceuticals
Summary: Spray drying is a manufacturing technique which can be used to formulate amorphous solid dispersions of drug substances to enhance their solubility and oral bioavailability, as well as in the development of improved formulations for inhaled drug products. Although spray drying is a well-established process, it presents certain challenges throughout drug development, and having robust science and experience-driven scale-up methodologies in place can help ease troubleshooting should the need occur. This article examines critical aspects of formulation development for spray-dried powders and the risk mitigation strategies that may be applied to address a range of common issues during production.