Major Revision of USP Chapter <1724> Semisolid Drug Products Performance Tests Published for Comment

In the current Pharmacopeial Forum, PF 48(3), a major revision of USP general chapter <1724> Semisolid Drug Products—Performance Tests is being proposed. This proposal is based on the version of the chapter official as of August 01, 2013.

The scope of the currently valid chapter is "to provide general information for performance testing of semisolid drug products, various types of equipment employed for such testing, and potential applications of the performance testing". Compared to the currently valid version, the scope of the new draft has been expanded. It also includes in vitro release test (IVRT) as well as in vitro permeation test (IVPT) methods, with discussions on experimental design, method development, and validation.

According to the briefing notes, the proposal further includes "new information on appropriate contexts of use for IVRT and IVPT studies, and a guide for selecting an appropriate test method (IVRT or IVPT) depending upon the goal of the experiment." In addition, the text contains "revise information related to test equipment for IVRT and IVPT studies, with general discussions on setup and qualification considerations for vertical diffusion cells, immersion cells, and flow-through diffusion cells." 

The text was also adapted and expanded in other parts. All these changes are noticeable in a more detailed structuring of the subchapters. The chapter is now divided into the following sections:

• Scope
• Introduction
• In vitro release test (IVRT)
• In vitro permeation test (IVPT)
• Equipment

The draft of the revised chapter is available on PF Online. (Please note: a one-time registration is required to access the Pharmacopeial Forum. Comments can be submitted until July 31, 2022.