The upcoming Aerosols–Inhalation and Nasal Drug Products Workshop sponsored by the United States Pharmacopoeia’s General Chapters-Dosage Forms Expert Committee will take place at USP headquarters in Rockville, MD on December 12 and 13, and the organizers are expecting that up to 75 OINDP specialists from industry, academia, and regulatory agencies will attend.
USP Headquarters
According to committee member Anthony Hickey, planning for the workshop began about a year ago. “The intent,” he explains, “was to be able to roll out a summary of the process revision that is going on with Chapter <601> and new Chapter <5>, to explain to some extent how these revisions came about, and to give people the opportunity for a few questions.” The changes are a result of the new 3-tiered taxonomy at USP, where the first tier is routes of administration; the second tier is dosage forms; and the third tier is type of release pattern.
Hickey will co-chair the first session of the workshop, which will review those changes, for which the committee has already received a great deal of public comment. “There is no intention at this meeting go line item by line item through those responses,” Hickey explains, noting that the changes to <601> are “fairly modest” and mainly in the area of formatting and that Chapter <5> “basically just documents things that the industry is already doing,” including quality tests such as polymorphism and moisture content.
The session will provide opportunities to interact with regulatory personnel; however, time limitations will preclude in-depth debate over the chapters, he says: “The predicament that we are faced with is that the last formal revision to <601> was back in 1990, so in some ways a workshop of this nature opens the gates for any sort of comment that might have happened in the intervening period, and the only thing that we’re trying to do is to channel the energy and enthusiasm that people have. “The fact that it’s new tends to draw interest,” he concedes; however, he suggests, “there shouldn’t be anything there that’s very alarming.”
