Biological permeation enhancers for transbuccal drug delivery

Ziel

Peptide drugs hold immense therapeutic potential but are primarily restricted to injectable administration due to poor permeability across biological barriers. While conventional permeation enhancers (PEs) have enabled oral absorption for a few peptides, their broader application remains constrained by limited efficacy. Developing a novel, potent class of PEs would provide a patient-friendly alternative to injections, expanding access to peptide therapies and improving treatment acceptance. This project aims to establish enzymatic PEs as a strategy for non-invasive transbuccal macromolecular drug delivery as a proof-of-concept application. Membrane-degrading enzymes will be evaluated alone and in combination for their ability to transiently enhance drug diffusion across the buccal mucosa. The project follows a stepwise validation approach, incorporating in vitro, ex vivo, and in vivo studies in dogs to ensure robust and clinically relevant evaluation of the PE performance. A substantial increase in bioavailability compared to current buccal formulations using conventional PEs will be the key translational benchmark to establish the superiority of enzymatic PEs for non-invasive peptide delivery. Upon successful validation, intellectual property protection will be pursued, and collaboration with industrial partner(s) will drive commercial development, positioning these PEs as a transformative technology for convenient peptide dosing. By leveraging enzymatic specificity with innovative delivery approaches, this project aims to address critical clinical and societal challenges, enhancing accessibility to macromolecule-based therapies while reducing reliance on invasive administration modes.

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