Status: Funded - Closed
Development of a multi-dose budesonide dry powder inhaler for pediatric patients
Bradley Sullivan, B.S., Ph.D.
BACKGROUND: The Centers for Disease Control and Prevention reported in 2012 that 6.8 million children were being actively treated for asthma in the United States. The growth of asthma in children worldwide represents a significant clinical need.
GAP: Nebulization therapy, which is commonly prescribed in asthmatic children <6 years of age requires cumbersome equipment that is not easily transported and requires lengthy administration times (~10-15 minutes). For asthmatic children >6 years of age, poor inhalation performance with dry powder inhalers or lack of coordination with pressure metered dose inhalers is common, which decreases the amount of efficacious drug deposited in the lung and increases the amount of drug deposited in the mouth and throat. These shortfalls of current pediatric inhalation therapy negatively affect long term compliance, therapeutic efficacy, and/or “off target” drug exposure.
HYPOTHESIS: Aerodynamically favorable budesonide particles (NanoClusters; low density/high surface area drug particles) will have improved dispersion performance at low breathing energy inputs (i.e., pediatric conditions) compared to currently prescribed Pulmicort™ budesonide dry powder.
METHODS: NanoCluster Budesonide formulations will be integrated into commercially available dry powder inhalers and screened for performance at pediatric flow rates for pre-clinical evaluation as an improved inhaled therapy for children >6 years of age. Budesonide NanoClusters will also be integrated into a small mechanical dry powder inhaler/spacer system and evaluated as an alternative to nebulization therapy for children <6 years of age.
IMPACT: Improvement of long term patient compliance, drug efficacy, and safety of inhaled asthma therapies for children will reduce the risk of asthma attacks and asthma-associated hospitalizations.