Local administration of biologic Active Pharmaceutical Ingredients to the lung via inhalation has grown in recent years. Dry and liquid dosage forms of protein-, peptide-, and nucleic acid-based therapies have been developed for respiratory delivery in clinical trials and as final commercial products. Excipients play a crucial role in the stability, safety, and efficacy of these therapies. However, there are still some challenges surrounding excipients within the respiratory arena, mostly driven by regulatory and technical aspects.
This webinar will cover:
- Regulatory landscape for respiratory excipients
- Role of excipients in biologic API stabilization
- Specific considerations for formulating liquid and dry dosage forms
- Challenges and opportunities for respiratory excipients
Key Learning Objectives:
- Understand the regulatory status of key inhalation excipients
- Recognize the role of excipients in stabilization of biologic APIs
- Differentiate between the formulation needs of liquid and dry powder dosage forms for inhalation