The United States Pharmacopeia (USP) has made significant changes to the Prednisone tablets used for Performance Verification Testing (PVT) of Dissolution Apparatus 1 (baskets) and 2 (paddles). We’ve gathered up all the necessary links and included some expert commentary from kenboda in this post to keep you up to date!
Key links from the USP
The following list includes a collection of key resources published by the USP detailing the most recent changes to the Prednisone tablets. Did the actual test change? How long can you use your existing tablets? What about Mechanical Qualification (MQ)? These answers and more can be found here:
- USP PVT Resource Page: Collection of videos, Dissolution FAQs, Methods Database, Calculation Tool, and PVT-related Podcasts
- USP Dissolution Resource Page: Primary starting page for general dissolution information
- USP PVT Brochure
- USP PVT FAQs
- USP PVT Video #1 – FAQs (03:27) - overview of changes to Prednisone tablets
- USP PVT Video #2 – Packaging & Handling (01:35) - summary of improvements to packaging and handling of Prednisone tablets
- USP PVT Store Webpage - links to purchase tablets & standard, calculation tool, Dissolution Toolkit (3.0), current and previous Lot Certificates
Ken’s comments (initially posted by kenboda on LinkedIn):
Did You Know the USP Prednisone Tablet is Changing?
There's a big change to the USP Prednisone Tablet happening on May 1st. The tablet is now called a Dissolution Performance Verification Standard (DPVS) and USP <711> has been changed to reflect the new qualification standard. If you are doing the USP PVT/PQ for your dissolution qualification, be aware of the changes. If you're qualifying per the ASTM/FDA Mechanical Qualification Procedure, there is no impact to you.
What's the big change with the new product?
Per USP, the tablet has been changed to have the behavior of the tablet more closely reflect the state of the dissolution unit itself and be less sensitive to other variables. The round shape of the tablet has been chosen to reduce some challenges that have been seen with previous lots such as floating tablets in baskets, not landing in the bottom center of the vessel, and being overly sensitive to vibration and dissolved gasses. Other less obvious changes have been made to help enhance reproducibility of the tablet itself.
Personally, I am hopeful that this new product will improve qualification and reduce false failures of dissolution systems. I've been critical of some previous lots, and the goals of this new product meet many of my concerns through the years. Fingers crossed!
Further Information
For more details about qualification, Agilent has you covered. Feel free to drop us a comment or question below or contact our experts directly at dissolution.hotline@agilent.com. Thanks for reading!
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