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.

As the group has also included the novel/special dosage forms in their focus, the co-chairs of the working group agreed to expand the working group name from the Dissolution Working Group to the Dissolution / Drug Release to better reflect the current activities.

This SIG published the FIP Guidelines for Dissolution Testing for Solid Oral Products in 1995 and for Dissolution / In Vitro Release Testing of Novel / Special Dosage Forms in 2003.




Meeting Report for the FIP/AAPS Joint Workshop: Dissolution/In Vitro Release Testing of Novel/Special Dosage Forms. Click here to download the article.




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 Dissolution working group of SIG BA/BE 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)

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


Workshops on "Special dosage forms - What's new with in vitro drug release?"

In addition to these Hands-on-dissolution workshop, the SIG Dissolution/ Drug release organised a Pre-satellite workshop on "Special dosage forms - What's new with in vitro drug release?" in London, October 20-21, 2008. This 2-day workshop presented drug release methodologies to evaluate the product performance for special dosage forms, such as, specialized oral dosage forms (orally disintegrating tablets, buccal, chewable) and non-oral dosage forms (topical, ophthalmic, inhalation, suppositories, stent, liposomes, microsphere, nanoparticle formulations).

A similar workshop was later organised in Los Angeles, in November 2009, in conjunction with the 2009 AAPS Annual Meeting and Exposition.