Formulation of Biologics for Inhaled and Nasal Delivery

Mark Parry, Derek Solomon, Mark Hammond, David Ward, Ashleigh Wake

Biopharmaceuticals are a vital part of modern pharmaceutical development however they are susceptible to a range of aggregation and degradation pathways which make the manufacture, processing and delivery of these products more challenging than more typical small molecules, with the majority of biologics being delivered parenterally. Inhaled and nasal delivery of biologic products allows for a more convenient method of administering compounds systemically, and also allows direct targeting of the respiratory system. The use of many biologics for long term disease management provides opportunities for repurposing of existing products for inhaled and nasal delivery to improve patient experiences and reduce complications from routine parenteral delivery. Examining excipient strategies and the impact of processing on biologics shows a variety of methods for managing the behaviour of biologic products, and examination of the common device technologies highlights the relative advantages of each type to fit with the physiological and commercial objectives. Examining the analytical techniques and the importance of understanding the activity and purity of the biologic product allows the development of a more suitable suite of tests to demonstrate the product safety and efficacy. Finally, review of real world case studies show how effective formulations can be developed by bringing together techniques for inhaled and biologic product development.

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