ABSTRACT
An increased industry focus on large molecule delivery, including peptides and proteins, has driven the development and adoption of particle engineering technology to enable the pulmonary delivery of non-crystalline therapeutic agents. In addition, the desire to improve and control aerosol performance in the product has motivated the inhalation field to use particle engineering to fine-tune particle properties. However, a significant challenge is the limited availability of Generally Regarded As Safe (GRAS) excipients for inhalation, which limits formulation options. This chapter summarises the particle engineering approaches used to develop novel formulations for excipients in approved products and clinical development, such as sugars, hydrophobic amino acids and oligopeptides, cyclic dipeptides, and phospholipids.
