Inhalable and nasal biologics: analytical, formulation, development, and regulatory considerations
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D Cipolla, CJ Gruenloh, N Kadrichu…
Journal of Aerosol …, 2025
journals.sagepub.com
Background: Delivering large molecules and biologics via inhalation or intranasal routes allows these innovative therapies to directly target the respiratory tract, access the richly vascularized lymphatic tissue in the nose for vaccination, bypass gastro-intestinal and first-pass hepatic metabolism for systemically active drugs, and provide a convenient alternative to injections. These advantages are driving significant growth in research and development within this field. However, before such products can reach the market, they must undergo …

