This course focuses on the major aspects related to the quality and performance of aerosols and inhaled medications as described in the USP–NF General Chapters <5> Product Quality Tests for Inhalation and Nasal Drug Products, General Chapter <601> Product Performance Tests for Inhalation and Nasal Drug Products, as well as other related chapters that will also be addressed.

Subject area:
Drug Products & APIs

Objectives (If applicable):
•Identify drug targeting as it relates to the lungs by oral inhalation and by topical application to the nasal cavity.
•Summarize and discuss the physico-chemical properties of inhaled aerosols/sprays/powders and mechanisms of dispersion.
•Explain the importance of quality testing and product performance as they relate to oral and nasal inhaled products.
•Identify the purposes of USP–NF General Chapters <5>, <601>, <1601>,<1602>, <1603> and draft <1604>.
•Understand the operation of the apparatuses for determining delivered drug uniformity (DDU) and aerodynamic particle size distribution (APSD) of inhaled products.

Target Audience (If applicable):
•QA/QC analysts and managers
•Analytical scientists and managers
•Product development staff
•Regulatory staff
•Consultants involved with regulatory science of inhalation products