One aspect of product quality is its in vitro performance that can be evaluated using procedures such as dissolution, drug release, disintegration, aerodynamic particle size distribution, etc. Work in this area includes dissolution tests, which can demonstrate whether a tablet or capsule reliably dissolves as intended to deliver its active ingredient to the patient; standards for transdermal drug products, and metered dose inhalers; as well as validated tests for excipient performance.
Learn more about some of USP’s recent developments in these areas:
New Product Performance Expert Panel
- An Expert Panel formed in 2018, New Advancements in Product Performance Testing, is working toward identifying opportunities for USP to partner with stakeholders and develop needed performance tests for a variety of drug products and delivery systems.
- The Expert Panel is looking not only at drug products and delivery systems currently in the USP-NF, but also newer drug delivery systems such as microneedles, dermal patches, stents, etc.
Biorelevant dissolution testing
- Workshop on Computer Modeling - In vitro and In vivo Studies
- Workshop on Advancements in In vitro Performance Testing of Drug Products
- Workshop Report: USP Workshop on Advancements in In vitro Performance Testing of Drug Products
Metered Dose Inhaler (MDI)/Inhalation
- Major revision to <601> Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders – Performance Quality Tests will be official May 1, 2021
- Workshop on Impact of Excipients on Inhalation Drug Products
- A new chapter, <1603> Cascade Impactor Practices, became official December 1, 2020.
- A Stimuli to the Revision Process article was published in PF 44(4): The Application of Abbreviated Impactor Measurement and Efficient Data Analysis in the Lifecycle of an Orally-Inhaled Product: A Roadmap.
- Revisions to a new General Chapter, <1604> Data Interpretation of Aerodynamic Particle Size Distribution Measurements for Orally Inhaled Products, were published in PF 46(5).
Excipient performance
- A major revision to <1059> Excipient Performance was published in PF 46(1), adding 29 new functional categories
Nanomaterials
- A new General Chapter, <1153> Drug Products Containing Nanomaterials, will become official on May 1, 2021.
