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 conferences and workshops. A symposium entitled “In-Vitro Release, Drug Delivery Design and Performance Study for Injectable Microspheres of Protein and Peptide Drugs” will be presented at the 2014 AAPS National Biotechnology Conference. A session titled “Biorelevant Dissolution: Where Are We?” will be presented at the 2014 AAPS Annual Meeting and Exposition.
- Continue participation in the International Outreach Program by sharing educational or training resources to countries where the pharmaceutical science infrastructure is underdeveloped. Malaysia and Vietnam are potential future sites.
- Improve the involvement of pharmaceutical students by utilizing the resources of Mercer University’s student chapter. Publicize student research on this webpage.
- 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 various publications. A dissolution-themed issue will appear in The AAPS Journal this year. An IVIVC-themed issue of Dissolution Technologies is being planned for 2015.
- Develop a format for discussing/sharing user questions among steering committee members and FG membership. Discuss and respond to current in-vitro release and dissolution issues and hot topics in a timely fashion.
- Conduct a 2014 face-to-face meeting of the IVRDT FG steering committee.
Section affiliation: APQ | FDD | RS