(752a) Quality by Design for DPIs -A Regulatory Perspective

Inhalation Powders have become an important dosage form in developing products for delivery to the lungs.  Since the approval of the first DPI in the US in the late 1990’s there has been a rapid surge in the number of drug development programs involving Dry Powder Inhalers.  The draft MDI/DPI guidance, developed more than 10 years ago, discuss approaches for CMC information to be submitted in an application.  An update to this guidance is being developed and the proposed regulatory recommendations for DPIs will suggest a Quality by Design (QbD) approach whereby a science and risk based understanding of the device design, its effect on the performance, and the patient interaction is sought.  Specifically, the impact of interaction of the critical quality attributes of the actives, excipients, device components, on the Quality Target Product Profile (QTPP) of the finished product (e.g. delivered dose, aerodynamic performance of the drug product) is an example of enhanced development information that can be included in applications.  These recommendations are in line with the Agency’s continued efforts to promote the implementation of QbD principles in drug development.