The quality of pharmaceuticals is still of great concern to FIP and the World Health Organization. The dissolution test has emerged as a most powerful tool to assess the product quality of a drug and its in vivo performance.
We are involved in enhancing the science in the field of dissolution. We also include novel/special dosage forms in our focus.
Who we are
The Focus Group on Dissolution/In Vitro Drug Release is chaired by Dr Horst-Dieter Friedel (Bayer, Germany). Current group members include 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.
|Some of the focus group members at Nanomedicines
workshop: (from left: Vinod Shah, Margareth Marques,
Amy Barker, Johannes Krämer, Horst-Dieter Friedel)
What we do
The group publishes guidelines and papers and holds workshops.
Our publications include:
- FIP Guidelines for Dissolution Testing for Solid Oral Products1995 (currently under revision)
- Dissolution / In Vitro Release Testing of Novel / Special Dosage Forms 2003
- 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: FIP/AAPS Joint Workshop: Dissolution/In Vitro Release Testing of Novel/Special Dosage Forms.)
Our workshops include:
- Biorelevant dissolution testing, Washington, USA, in 2013. (The results of the workshop were published in Pharmaceutical Research, 31:1867-76, 2014.
- Oral Biopharmaceutics Tools: What is New and What is Coming? APV/FIP Joint-Workshop in Nuremberg , September 26-27, 2017
- Nanomedicines The group organised, in collaboration with AAPS (American Association of Pharmaceutical Scientists) and USP (US Pharmacopeia), a three-day workshop on nanomedicines in Rockville, USA, in March 2017. Over 150 representatives from industry, academia, regulatory and pharmacopeial bodies participated. New scientific and regulatory perspectives were the focus of this workshop.
- “Hands-on-Dissolution” Workshops Since 1999, the focus group has initiated 13 “Hands-on-dissolution” workshops in collaboration with the WHO to improve the drug product quality, especially in developing countries. The most recent was held in Bucharest, Romania, in 2016. All these workshops have been well attended and participants receive FIP certificates of attendance.
For more information on this focus group, please contact Dr Friedel at RegulatorySciences@fip.org