In-vitro testing of drug release is a valuable tool for formulation development and for the quality assessment of finished products. As new dosage forms evolve, in-vitro release tests such as dissolution are constantly being improved with newer equipment and methodologies. This focus group provides a discussion forum across industry, regulatory agencies, and academia to better understand the evolving role of dissolution testing and facilitate growth in its appropriate use and value. A desired result is the development of standardized, relevant methods that can meet the challenges of new dosage forms and encourage innovation. The IVRDT FG provides educational resources to support international outreach programs, develops programming for conferences and workshops, and promotes publications on dissolution testing and related topics.
Goals and Objectives
- Develop and conduct dissolution-related webinars. The next planned webinar is “Dissolution in the Product Lifecycle” (in progress).
- Generate programming ideas for AAPS Annual Meeting and Exposition and AAPS workshops.
- Enhance FG participation by university students. Tap into the resources of the AAPS university organizations. Publicize student research by posting on the FG website.
- Complete a “white paper” publication on alcohol dose-dumping, including formulation trends and regulatory requirements for in vitro testing.
- Solicit themes and authors for ‘special edition’ issues of Dissolution Technologies.
- Continue participation in the International Outreach Program by sharing educational or training resources to countries where the pharmaceutical science infrastructure is underdeveloped. Malaysia, Vietnam, and Peru are potential sites.
Section affiliation: APQ | FDD | RS