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

摘要: 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 vivo behavior of an oral drug product by performing vitro studies. Similarly, there interest application modern computational fluid dynamics (CFD) frameworks and high-performance computing platforms study local processes underlying absorption within gastrointestinal (GI) tract. In that way, CFD both can inform future PBPK-based silico determine GI-motility-driven hydrodynamic impacts should be incorporated into methods for relevance. Current compendial not always reliable predict behavior, especially biopharmaceutics classification system (BCS) class 2/4 compounds suffering from a low aqueous solubility. Developing test will reliable, cost-effective less time-consuming as long power sufficiently strong. There need develop biorelevant, method applied pharmaceutical companies facilitate marketing access generic novel products. 2014, Prof. Gordon L. Amidon his team initiated far-ranging research program designed integrate (1) studies humans order further improve understanding intraluminal processing dosage forms dissolved along tract, (2) advancement methodologies incorporates higher levels relevance (3) experiments dissolution, transport intestines performed with new unique based framework. Of particular importance revealing physiological variables determining variability GI person address (potential) BE failures. This paper provides introduction this multidisciplinary project, informs reader about current achievements outlines directions.