Course Description:
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.
Upon completion of this course, you will:
- 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 inhalation products
- Identify the purposes of USP–NF General Chapters <5>, <601>, <1601>, <1602>, <1603>, and the draft version of <1604>
- Understand the operation of the apparatuses for determining delivered drug uniformity (DDU) and aerodynamic particle size distribution (APSD) of inhaled products.
Who should participate:
- QA/QC analysts and managers
- Analytical scientists and managers
- Product development staff
- Regulatory staff
- Consultants involved with regulatory science of inhalation products
The live version of this recording took place on April 20-21, 2022
Access Duration:
Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
USP Approved Instructor
Jolyon P. Mitchell Ph.D., F.R.S.C. (UK), C. Chem, C. Sci
President and owner of Jolyon Mitchell Inhaler
Consulting Services Inc., London; Ontario, Canada