Over the past five years, the increased approval rate of intranasally delivered molecules has provided evidence of growing interest and opportunities in the route for both local and systemic administration. However, there are as many risks to developing and manufacturing nasal spray drug products as there are opportunities, especially in the area of chemistry, manufacturing and controls (CMC). Failing to identify and mitigate such risks can lead to noncompliance with performance and quality requirements, bringing safety and efficacy issues that could jeopardize patients as well as the entire drug development program.
In this webinar, experts will discuss problems common to the development, testing and manufacturing of intranasal drug products, their potential causes, and possible consequences. Experts will then make recommendations for preventing them, or mitigating their effects.
Key Learning Objectives:
- Have a practical understanding of the challenges inherent to nasal drug development, analytical testing and manufacturing
- Learn about the interplay between formulation-dependent variables, device-dependent variables and analytical methods in affecting the drug product performance and quality of nasal sprays
- Discuss risk mitigation strategies, using real-world examples
