Focus Group on Dissolution/In Vitro Drug Release

Co-Chairs: Dr Horst-Dieter Friedel and Ms Cynthia K. Brown

Please note that, as of September 2011, Dissolution/In Vitro Drug Release is a Focus Group that falls under the SIG on Regulatory Sciences.

Current Focus group members include:  Horst-Dieter Friedel, Cynthia K Brown, Amy R. Barker, Vinod P Shah, Johannes Krämer, J. Michael  Morris,  Christos Reppas,  Lucinda Buhse, Susanne Keitel, Mary P Stickelmeyer, Margaret Marques, Kumiko Sakai-Kato.

As the group has also included the novel/special dosage forms in their focus, the name was expanded from Dissolution Working Group to the Dissolution / Drug Release to better reflect the current activities.

The SIG/FG is involved in enhancing the science in the field of dissolution. Previously, the FG published the FIP Guidelines for Dissolution Testing for Solid Oral Products in 1995, which is currently under revision, and for Dissolution / In Vitro Release Testing of Novel / Special Dosage Forms in 2003. The FG issued a position paper on Qualification of Paddle and Basket Dissolution Apparatus in 2009. After holding two international workshops, they published the report on Dissolution / In Vitro Release Testing of Novel /Special Dosage Forms in 2011. (Meeting Report for the FIP/AAPS Joint Workshop: Dissolution/In Vitro Release Testing of Novel/Special Dosage Forms. Click here to download the article.)

A workshop on Biorelevant dissolution testing was organized in the United States in 2013. The results of the workshop have been published in Pharmaceutical Research, 31: 1867-1876, 2014..  A workshop with a similar concept will be held in collaboration with APV in Europe in September 2017 with the title Oral Biopharmaceutics Tools: What’s new and what’s coming?

The group organized in collaboration with AAPS (American Association of Pharmaceutical Scientists) and USP (US Pharmacopeial  Convention) a three-days Workshop on Nanomedicines at the USP meeting Center in Rockville, MD USA, in March 2017. More than 150 representatives from Industry, Academia, Regulatory and Pharmacopeial bodies participated in this workshop.  New scientific and regulatory perspectives were in the focus of this workshop.


Some of the focus group members at Nanomedicines workshop: (from left: Vinod Shah, Margareth Marques, Amy Barker, Johannes Krämer, Dieter Friedel)


The SIG on Dissolution/Drug release is also involved in:

FIP "Hands-on-Dissolution" Workshops

The quality of pharmaceuticals is still of great concern to FIP and WHO. The dissolution test has emerged as a most powerful tool to assess the drug product quality and its in vivo performance. The FG has initiated "Hands-on-Dissolution" workshops in collaboration with WHO to improve the drug product quality, especially in developing countries. These types of workshops were organized in:

1. Melbourne, Australia (July 1999)
2. Mumbai and Bangalore, India (January 2001)
3. Ho-Chi-Minh, Vietnam (March 2003)
4. Bangkok, Thailand (March 2003) 
5. Beijing and Shanghai, China (April 2004) 
6. Bucharest, Romania (October 2005)
7. Istanbul, Turkey, (October 2005) 
8. Warsaw, Poland, (June 2007)
9. Ho Chi Min City (November 2007)
10. Uruguay (November 2008)
11. Porto Alegre, Brazil (May 2010)

12. Poiana Brasov, Romania (June 2012)

13.Bucharest, Romania (June 2016)


All these workshops were well attended. Participants receive FIP certificates of attendance. These workshops have been very successful outreach activities of FIP.