By Lliralyn M. McEachern, BSc; Thomas S. Lund, BSc ;and Alan B. Watts, PhD; Catalent Pharma Solutions
The spray-drying process enables the production of powders with a tightly controlled range of particle sizes and solid- state properties. Formulators have control over the crystalline and amorphous character as well as the radial distribution of components and particle morphology.
Successfully designing an inhaled formulation and the associated spray-drying process requires thoughtful consideration on a number of key process inputs and variables. Atomization, solution composition, solvent and excipient selection, and particle collection are some of the factors that have the largest inﬂuence on material properties.
The particle size of the drug product is critical for inhaled therapies, and optimizing these variables to manufacture particles of the targeted size requires understanding the properties of the ingoing API, the utility of the available excipients, and the process parameters connected to product quality attributes. Learn how advanced considerations for the formulation and spray drying process can help manufacture a stable, highly respirable powder and deliver products that require high drug load, a biologic, or rapid onset therapeutic.