471328 Scientific and Regulatory Considerations on Particle Engineering for Dry Powder Inhaler (DPI)

Thursday, November 17, 2016: 1:45 PM
Continental 4 (Hilton San Francisco Union Square)
Zhigang Sun, Division of Process Assessment II, Office of Process and Facilities, OPQ, CDER, FDA, Silver Spring, MD

Dry Powder Inhaler (DPI) is a leading pulmonary drug delivery technology for the treatment of asthma, chronic obstructive pulmonary disease (COPD), and respiratory infections. For DPI drugs, due to significant impact of the dry powder properties on the inter-particle interactions as well as aerosol performance, particle engineering provides an effective approach for development and optimization of particulate formulation to ensure efficient drug delivery as well as optimal therapeutic outcomes. An advanced particle engineering technique can further improve the pharmaceutical manufacturing process to minimize all possible sources of the product variability and to ensure manufacturing consistency as well as drug product quality.  

Recently, a variety of particle engineering techniques have been adopted for formulation development and commercial manufacturing of DPI drugs. For each particle engineering technique, in-depth understanding and control of the particulate and solid-state properties for dry powders is critical. This presentation will discuss various particle engineering techniques available for manufacture of DPI and will focus on scientific and regulatory considerations for characterization and control of dry powder properties for DPI drugs. This presentation will also include a discussion of regulatory submission expectations with regard to characterization and control of the particulate and solid-state properties for dry powders based on commonly seen deficiencies in new drug applications (NDAs) and abbreviated new drug applications (ANDAs). The objective of this presentation is to illustrate how to use a risk based approach as advocated by the Quality by Design (QbD) paradigm for developing particle characterization methods as well as establishing control limits for key dry powder properties of DPI drugs to ensure reproducible commercial manufacturing for consistent product quality.

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