Optimizing Spray Drying Strategies for Commercial Pharmaceutical Manufacturing
Summary:The use of spray drying to manufacture amorphous dispersions is continuing to grow due to the number of drug candidates exhibiting poor solubility. Apart from addressing solubility, spray drying is a reproducible processing technology that offers improved production efficiency that can potentially reduce cost and time-to-market. Phase-appropriate Quality by Design framework can increase the understanding of the interplay between the process parameters of spray drying and product quality that, when applied during scale-up, increases the chances of a successful outcome of the commercial manufacturing process.
It is essential to select a robust formulation in the early phase for easier scale-up during development and manufacturing. Small-scale experiments, risk assessments and process development experience and knowledge are keys to a successful scale-up strategy.