United States Pharmacopeia Establishes Project Team on Dissolution Calibration

William Brown
United States Pharmacopeia, Rockville, MD

To facilitate communications, the United States Pharmacopeia (USP) has established several stakeholder forums to allow information exchange and focus on specific issues. One of these is the Prescription/ Non-Prescription Industry Stakeholder Forum that has met three times and is scheduled to meet again on May 13, 2002. In these meetings, several issues have been raised and project teams have been established to consider selected issues more fully.

One of these teams is the USP Dissolution Calibration Project Team. The team is chaired by Vivian Gray of the USP Biopharmaceutics Expert Committee (BPC) with the following members: Thomas Foster, (chair of the BPC); John Mauger, BPC; Lew Leeson, BPC; Frank Holcombe, Jr., Food and Drug Administration Center for Drug Evaluation and Research; Jennifer Dressman, International Pharmaceutical Federation (FIP); Mary Oates, Pharmaceutical Research and Manufacturers of America(PhRMA); Pranab Bhattacharyya, Generic Pharmaceutical Association (GPhA); Werner Mueller, Gerry Brinker, Roy Hanson, Jean-Louis Raton, and Bryan Crist. The last five team members listed represent dissolution apparatus manufacturers. The team met on August 16, 2001.

The team is charged with recommending a suitable calibration procedure for dissolution apparatuses to the USP BPC. Extensive discussions of the functions of a calibrator tablet took place. The team will meet again in the late spring of 2002. Input to the team may be submitted by contacting the various industry or FDA representatives or by contacting Will Brown, who serves as the project manager at USP. Contact Will by telephone at 301-816-8380 or by e-mail at web@usp.org.