The field of inhaled biologics is rapidly expanding, with both dry and liquid formulations of proteins, peptides, and nucleic acids gaining traction in clinical and commercial applications. Excipients are vital for ensuring the stability, safety, and efficacy of these therapies. However, navigating the regulatory and technical complexities of respiratory excipients remains a significant challenge.
This paper covers the role of excipients within these therapies, including the stability of the API and the efficacy and safety of a treatment. Early in the development of an inhaled treatment, excipients must be considered due to their direct impact on a therapeutics' manufacturability, stability, and performance. We will address:
- The regulatory landscape for respiratory excipients.
- The critical role of excipients in stabilizing biologic APIs.
- Specific formulation considerations for liquid and dry dosage forms.
- The challenges and opportunities surrounding respiratory excipients.
Want to delve deeper into these topics? Our webinar, "Excipients for Respiratory Delivery of Biologics," provides a comprehensive exploration of these challenges and solutions. Learn from industry experts and gain practical insights into optimizing your respiratory biologic formulations.