Formulation of Biologics for Inhaled and Nasal Delivery
What are the major points to consider when formulating biologics for inhaled and nasal delivery?
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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 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. This white paper examines the excipient used and the potential impact of processing on biologics with a brief look at strategies for managing the behaviour of biologic products.
Common device technologies are examined and the relative advantages of each type to fit with the physiological and commercial objectives of inhaled or nasal delivery are discussed. A review of the most appropriate analytical techniques and what data they can provide to help understanding of the activity and purity of the biologic product are discussed with the focus on the development of a suitable suite of tests to demonstrate the product safety and efficacy. Finally, review of real world case studies illustrates how effective formulations can be developed by combining techniques for inhaled and biologic product development.
Download our White paper: Formulation of Biologics for Inhaled and Nasal Delivery