(451) Advancing Oral Delivery of Biologic Drugs: Overcome Formulation Challenges with Permeation Enhancers

Introduction: Permeation enhancers (PEs) are the leading strategy, with two approved oral peptide drugs Rybelsus® and Mycapssa. Sodium caprate (SC) is widely evaluated to improve the intestinal absorption of peptides via the paracellular and transcellular pathways. However, the poor flow and compression characteristics of SC have limited its utility in tablet processing. To overcome these limitations, a new process-engineered SC with improved flow and compaction to ease processing and yield more robust tablets than existing SC was developed and compared with commercially available SC.