ICYMI: Dissolution Discussion Group (DDG) Event Recap > Revisions to USP Chapter <1724> Semisolid Drug Products – Performance Tests

The Dissolution Discussion Group (DDG) kicked off 2023’s calendar with an informative and spirited discussion regarding the upcoming changes to USP General Chapter <1724> that deals with the performance tests of semisolid drug products. This typically refers to topical formulations and liquid-based dosage forms – such as creams, gels, ointments, or lotions – applied directly to the skin.

For this session, the DDG was fortunate to welcome the following group of esteemed panelists including a special guest from the United States Pharmacopeia (USP), Dr. Margareth Marques.

  • Bryan Crist (Moderator) – President of DissoAssist Consulting
  • Ken Boda – US Dissolution Product Specialist at Agilent Technologies
  • Vivian Gray – Editor at Dissolution Technologies and President of VA Gray Consulting
  • Margareth Marques – Senior Principal Scientist / Liaison for Dissolution and Drug Release Standards at USP

After a brief introduction, the meeting began with an overview of the upcoming changes, as well as new additions, to the general chapter <1724> by Bryan Crist. Further details were then delivered by Dr. Marques with specific focus on the following:

  • Difference between IVRT (in vitro release test) and IVPT (in vitro permeation test) for semisolid drug products, and when each type of test is most appropriate
  • Guidance related to experiment design, method development and validation, test equipment and qualification
  • Membrane selection with reference to a new general chapter <1002> Filters and Membranes that is being developed to include advice about synthetic and human/animal skin

Several resources from regulatory agencies and industry leaders were provided throughout the discussion for attendees to research further. Links to key guidance documents from the US FDA as well as the USP Pharmacopeial Forum for details on proposed and upcoming changes have been provided below for your reference:

As always, we’d like to thank the panelists for their insight on this topic, and the attendees for their questions and contributions to the meeting. Join us for the next online gathering where we’ll explore the Dissolution Lab of the Future on 25-May-2023 – registration is open, and we hope to see you there! Click HERE to register for upcoming DDG events or listen to recordings of previous meetings.

Agilent's Enhancer (Immersion) Cell meets the requirements for semisolid testing as described in the USP General Chapter <1724>. For product information or expert assistance, check out this helpful Enhancer Cell Tutorial Video or contact us directly at the Dissolution Hotline. Thank you for reading!

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