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Excipients in orally inhaled protein formulations: current examples, challenges, and future directions
Bhupinder Kaur1, Thomas Sécher1, Nathalie Heuzé-Vourc'h1
1Université de Tours, Centre d'Etude des Pathologies Respiratoires, Tours, France; INSERM, UMR 1100, Centre d'Etude des Pathologies Respiratoires, Tours, France.
None:
Inhaled protein therapeutics offer a direct route to the lung and hold strong promise for improving respiratory disease treatment. Their development, however, is complicated by the intrinsic fragility of proteins and the physical stresses imposed during aerosolization. Formulation options are further constrained by the limited number of excipients approved for inhalation, which are crucial for minimizing aggregation, degradation, and loss of delivery efficiency. This review outlines key requirements for inhaled formulations, surveys FDA-approved inhaled biologics and excipients, and highlights emerging formulation strategies and advanced delivery systems. It also discusses future priorities, emphasizing novel excipients, improved stability, and clearer regulatory guidance.
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