What are the Challenges in Developing Formulations for Neonates?
Developing formulations for neonates comes with several challenges:
- Limited Clinical Data: There is often a lack of extensive clinical trials involving neonates, making it difficult to establish safety and efficacy. - Stability and Shelf-life: Many formulations need to have a long shelf-life, but also require stability at various temperatures to ensure efficacy. - Excipients: Choosing safe excipients is critical as some substances that are safe for adults can be harmful to neonates.
