Designing inhaled protein therapeutics for topical lung delivery: what are the next steps?
Résumé
Respiratory diseases (RDs) constitute a major public health issue worldwide, and some RDs represent a significant unmet medical need. Inhaled protein therapeutics are now attracting increasing interest for the topical treatment of RDs, with one drug on the market and almost 20 others in clinical development. Here, we review advances in inhaled protein therapeutics and comment on the development strategies that can be considered. To date, the transformation of a therapeutic protein into an inhalable drug has often been performed on a case-by-case basis by taking account of specific protein-, inhaler-, and patient-related factors. A rational design process for both the drug formulation and the delivery device
is crucial for maintaining the protein’s integrity and optimizing deposition in the lung, which in turn are decisive for clinically successful aerosol therapy. Despite significant advances in this field, there are still a number of outstanding questions about the stability of nebulized proteins and the consequences of nebulization on the biological activity, safety and pharmacokinetics of these innovative therapeutics. A better understanding of these parameters should promote the implementation of more rational development strategies, and thus accelerate progression towards clinical applications
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10.1080-17425247.2018.1503251_Bodier-Montagutelli et al 2018 (1).pdf (387.51 Ko)
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