Formulation Development Of Enterically Protected Spray Dried Dispersions Of Adrulipase

Oral delivery of therapeutic proteins and peptides is inherently difficult due to their poor stability in the gastrointestinal tract, especially in acidic conditions. Exocrine pancreatic insufficiency (EPI), a condition resulting from pancreatic lipase deficiency, is currently treated primarily with porcine pancreatic enzyme replacement therapy (PERT). Adrulipase, a recombinant, non-porcine lipase, is in development as an alternative treatment for EPI.

To achieve optimal delayed-release and maintain Adrulipase activity, several formulations were developed as enteric-protected spray-dried dispersions (SDDs). The study evaluated nine formulations with varying excipients, including HPMCP, HPMCAS, maltodextrin, and arginine. The lead formulation, SDD04, containing HPMCP and maltodextrin, demonstrated superior acid protection and rapid release under intestinal conditions. Explore the full results, including stability data, and the potential of SDDs for future oral protein therapeutics.