Quality by Design for Orally Inhaled Drugs: Chemistry, Manufacturing, and Controls (U01)

Food and Drug Administration

Description

The project highlights the following important areas in chemistry, manufacturing and controls of dry powder inhaler (DPI) drug products: -Controlling the manufacturing of API crystals in order to obtain micronized API materials with low variability and consistency; -Defining the critical quality attributes of the API crystals that must be measured and controlled to ensure quality in the final drug product; -Emphasizing the relationship between the properties of the API crystals and the quality of micronized API materials to be in included in the final drug product; -Exploring the effects of post-micronization relaxation of micronized API on product performance, with an aim to understand the requirements for laagering and quarantining of micronized API materials.

Who can apply

• County governments
• City or township governments
• Independent school districts
• Native American tribal governments (Federally recognized)
• Native American tribal organizations (other than Federally recognized)
• Nonprofits with 501(c)(3) status (other than higher education)
• Nonprofits without 501(c)(3) status (other than higher education)
• For-profit organizations other than small businesses
• Others

Contact

Lisa Ko <br/>Grants Management Specialist
lisa.ko@fda.hhs.gov