Will summer meeting bring USP, FDA agreement on dissolution testing?

Dissolution testing, specifically the use of "tablet testers" to assess the stability of solid dosage forms, has become a controversial topic.

Some experts suggest that process analytical technology methods such as NIR, and USP methodologies should still be used together, with USP methods as a final "security" test, but a growing number of people seem to agree that the USP tests shouldn't be considered sacrosanct or definitive, on their own, since they can increase process variability.

ASTM's E-55 committee is arranging for a meeting on the subject of stability testing that should be quite interesting (well, as interesting as these types of meetings get, anyway), particularly since USP is a full voting member of E-55.

The meeting is planned for some time during the third quarter, somewhere on the East Coast.

At this point, a revised dissolution testing draft document is already out for E-55 members' votes. This draft vote represents the first time that E-55 is tackling a subject that involves, not only technical debate, but a controversial issue, in which some stakeholders (including USP and some consultants) hold entrenched commercial positions, according to a source within E-55.

Issues remain with the technical requirements in the draft, but our source says that a growing number of E-55 committee members agree that using dissolution calibrator tablets introduces greater variability into the stability testing process.

This issue may well end up being resolved within E-55 by a member vote, the source says, noting that ASTM has the structure and mechanisms in place to allow this to happen. A final decision will be made once a majority vote is reached, and, presumably, FDA will have to accept that decision.

The fact that this voting can even occur, as our E-55 source says, signals a major change within FDA. "The Agency can no longer stamp its feet and say "you must," but must now win the scientific debate. This is one of the really bright spots in the industry at the moment."

What's your opinion on stability testing? Please let us know.

-AMS