Fast-Into-Man Model for DPI

Fast-into-Man Model for Dry Powder Inhaler (DPI) Development

Authors: Lei Mao, PhD, LaMonica Ware, Lani Kroopnick, David Hall, Kerry Eischen, Tyson Anderson, Briana Pridgen, Craig Davies-Cutting, PhD, Catalent

Summary: Increased incidence of pulmonary diseases such as asthma, COPD, and other respiratory-related symptoms has triggered continuous efforts in searching for superior remedies such as new therapeutic agents and combination therapies. A rapid development model for formulation feasibility research and accelerated stability evaluation, through cGMP manufacturing to finished product release for dry powder inhalation products, is presented.