Spray-dried solid-state biologics are gaining interest for their enhanced stability and inhalation potential compared to liquid forms. Trehalose, a common stabilizer, is hygroscopic and can cause particle agglomeration under high humidity, negatively affecting inhalation. Consequently, mannitol and L-leucine are commonly added as dispersion enhancers, but, have been less studied for its effects on protein stability and inhalation. This presentation would include studies describing the role of excipients in spray-dried protein formulations for pulmonary delivery. While increasing trehalose improves protein stability, higher L-Leucine content may lead to increased monomer loss due to crystallization. Therefore, choice of excipient ratio should be such that it allows one to maintain protein stability without compromising aerodynamic performance. The goal of this presentation is to show how excipients such as leucine and trehalose impact long-term storage stability and aerosol performance of spray-dried protein formulations.
Learning Objectives:
Upon completion, participants will be able to learn how the excipient components impact storage stability of protein formulations
Upon completion, participants will be able to learn how the excipient components impact aerosol stability of protein formulations
Understanding the rationale of protein stabilization and improved aerosol performance by excipients
