Inhalation Products Expert Groups: Helping to Fill the Gaps - continued

Pharmacopeias USP Aerosols Expert Committee. The Aerosols Expert Committee (AEC) of the US Pharmacopeia (USP) comprises scientists from industry, academia, and FDA, who offer their expertise to help develop pharmacopeial standards for aerosol drug products. The committee’s goals for the past five-year cycle, which ended in March 2005, included modernization and international harmonization of relevant USP chapters (〈601〉 and parts of 〈905〉); development of monographs for HFA propellants, lactose for inhalation, and other excipients; and updating existing monographs for inhalation drug products, including mensuration issues of impactors. A strong working relationship has been established with the European Pharmacopeia’s Inhalanda group, with representatives sitting on both groups. USP Project Team Aerosols (PT 7). Recognizing the need for additional input from volunteer experts, USP has developed a new mechanism, project teams, to serve as advisory bodies to the USP expert committees. In 2002, Project Team 7, Aerosols, was constituted to supplement AEC’s expertise and resources. Like AEC, its members include scientists from industry, FDA, and academia, who aim to develop consensus proposals for pharmacopeial chapters for selected quality tests. As its first topic, the group focused on microbiological tests and specifications for inhaled and nasal products, and in 2003 the group submitted its recommendations to AEC for consideration and eventual inclusion in USP standards (27). European Pharmacopeia Inhalanda Expert Group. Inhalanda is one of the working groups of the European Pharmacopeia (EP) within the European Directorate for the Quality of Medicines (EDQM). Inhalanda comprises experts in inhalation preparations from major European member states. Inhalanda is working on revising monographs and test chapters, including those addressing aqueous delivery inhalers, nasal products, and impactor mensuration. Within the process of international harmonization among the US, European, and Japanese pharmacopeias, the EP is the coordinating (lead) pharmacopeia for the topic of aerodynamic assessment of fine particles in inhalation products. Inhalanda played a critical role in advising the EP on this topic and accommodating public comments received on the draft version of EP chapter 2.9.18. The group’s current focus is considering how the NGI for aerosol particle size characterization could be phased into the pharmacopeias. An NGI monograph has been drafted for comment to be included in both the USP and the EP. New academic trends There is a growing trend for academia to develop partnerships and centers of excellence to deal with a number of technical topics, some of which have a broad scope across a number of industries but have pertinence to the field of inhalation products. PQRI is one example. Another example of such a group is the Industrial Center of Particle Science and Engineering (Leeds and Sheffield Universities, UK). Such groups provide all participants with a useful opportunity to work collaboratively to understand and resolve particular problems or to advance in general pharmaceutical aerosol science. Coordination among expert groups The formation of expert groups to develop recommendations for guidances or standards has accelerated in recent years. With the great number of independent groups working on similar or potentially overlapping issues, there is also a clear need for coordination and communication among all parties. The major participants are shown in Figure 2, and these need to have a good dialogue and be able to be inclusive of the other expert groups as need arises. It is hoped that this article is a first step in raising general awareness of all groups, their missions, activities and plans. As experts combine their knowledge and share perspectives, the most optimal solutions are more likely to be found. (continued)