(183g) Control Strategy for Manufacturing of Dry Powder Inhalation Capsules: A Regulatory Perspective

Dry Powder Inhalation (DPI) is a leading drug delivery technology for the treatment of chronic pulmonary diseases, such as asthma and chronic obstructive pulmonary disease (COPD). DPI capsules provide a portable, simple-to-use, and cost-effective way to deliver inhalation medication. However, manufacturing of low-dose DPI capsules with consistent delivered dose and fine particle dose is not an easy task due to the complex interactions between drug formulation, delivery device design, and patient usage.  Quality by design (QbD) provides an effective tool to systematically evaluate, understand, and refine the formulation and manufacturing process to ensure predefined product quality to meet the needs of the patient. In this presentation, the manufacturing process of low-dose DPI capsules will be used as an example to illustrate how to implement QbD principles to enhance product and process understanding and to implement effective process controls to ensure reproducible commercial manufacturing for consistent product quality.  The purpose of this talk is to provide a regulatory perspective with regard to a QbD-based control strategy for the manufacturing process aspects of low-dose DPI capsules.