The need for pediatric pharmaceutical formulations has been growing rapidly in recent years as a result of the recognition that children are often underserved by ad-hoc compounding of adult formulations and increased regulatory incentives. Pediatric drug products can be challenging to develop due to their unique requirements and limitations.
Examples of these challenges include:
- Effects of growth and development on drug ADME
- Poorly soluble drugs with incomplete absorption,
- Safety concerns of commonly used excipients in pediatric patients
- Taste evaluation and masking
- Age appropriate dosage forms and flexible dosing
- Combination drug products for pediatric patients
This conference is intended to promote an informed discussion of the issues, strategies, and approaches for addressing these challenges.
Goals and Objectives
- Present current state-of-art technologies suitable for pediatric drug products
- Review technical issues including flexibility of dose titration, ease of administration and swallowing, palatability, solution stability, microbial challenges, dosing and measuring devices, considerations of a multi-phase and/or multi-use product, and packaging
- Discuss practical development strategies to facilitate the selection of pediatric dosage forms for clinical trials and commercial manufacturing
- Discuss special considerations and issues unique to pediatric products from the regulatory agency perspective (US FDA and the EMEA),
- Initiate a flow diagram/guideline for pediatric formulations development
Who should attend?
Pharmaceutical formulation scientists and product development scientists at all levels from industry and academia, clinicians, clinical pharmacologists, regulatory scientists and professionals, scientists working on developing novel pediatric dosage forms and dosing devices for pediatric products, and anyone with an interest in pharmaceutical pediatric dosage forms.