Formulation predictive dissolution (fPD) testing to advance oral drug product development: An introduction to the US FDA funded ‘21st Century BA/BE’ project

Publication date: 5 September 2018 Source:International Journal of Pharmaceutics, Volume 548, Issue 1 Author(s): Bart Hens, Patrick Sinko, Nicholas Job, Meagan Dean, Jozef Al-Gousous, Niloufar Salehi, Robert M. Ziff, Yasuhiro Tsume, Marival Bermejo, Paulo Paixão, James G. Brasseur, Alex Yu, Arjang Talattof, Gail Benninghoff, Peter Langguth, Hans Lennernäs, William L. Hasler, Luca Marciani, Joseph Dickens, Kerby Shedden, Duxin Sun, Gregory E. Amidon, Gordon L. Amidon Over the past decade, formulation predictive dissolution (fPD) testing has gained increasing attention. Another mindset is pushed forward where scientists in our field are more confident to explore the in vivo behavior of an oral drug product by performing predictive in vitro dissolution studies. Similarly, there is an increasing interest in the application of modern computational fluid dynamics (CFD) frameworks and high-performance computing platforms to study the local processes underlying absorption within the gastrointestinal (GI) tract. In that way, CFD and computing platforms both can inform future PBPK-based in silico frameworks and determine the GI-motility-driven hydrodynamic impacts that should be incorporated into in vitro dissolution methods for in vivo relevance. Current compendial dissolution methods are not always reliable to predict the in vivo behavior, especially not for biopharmaceutics classification system (BCS) class 2/4 compounds suffering from a low aqueous solubi...
Source: International Journal of Pharmaceutics - Category: Drugs & Pharmacology Source Type: research