Developing a Dry Powder Formulation for Aptar Pharma Prohaler®

Aptar Pharma Prohaler® is a novel, high performance, multidose dry powder inhaler device with a patient-centric design developed to promote patient compliance.

This paper describes the optimization of a model formulation for Prohaler® via manipulation of the concentration of fine lactose and the inclusion of a force control agent, to reduce the strength of interparticle forces and promote dose deaggregation. The relationship between formulation composition and dissolution profile was also investigated. The inclusion of a force control agent was shown to be highly beneficial in promoting aerosolization, resulting in a higher fine particle mass and a finer mass median aerodynamic diameter. This effect was robust with respect to lactose fine concentration which in the absence of a force control agent was also observed to correlate positively with fine particle mass. Consideration of the use of force control agents is highly recommended when developing formulations for Prohaler®.