Oral biopharmaceutics tools: recent progress from partnership through the Pharmaceutical Education and Research with Regulatory Links collaboration

Abstract Objectives To summarise key contributions of the Pharmaceutical Education and Research with Regulatory Links (PEARRL) project (2016–2020) to optimisation existing development new biopharmaceutics tools for evaluating in vivo performance oral drug products during drugs at regulatory level. Key findings Optimised tools: Based on clinical data, composition biorelevant media simulating fed state conditions stomach was simplified. Strategies how incorporate vitro data bio-enabling into physiologically based pharmacokinetic (PBPK) modelling were proposed. Novel Small-scale two-stage biphasic dissolution dissolution-permeation setups developed facilitate understanding supersaturation effects precipitation risks orally administered drugs. A porcine fasted simulated intestinal fluid improve predictions interpretation preclinical results using studies. recommendations design methodologies GI transfer process suggested. The optimized studies investigating food effects: effect study protocol pig model established which successfully predicted food-dependent bioavailability two compounds. infant healthy adults absorption evaluated versus conditions, as defined by agencies adults. Using PBPK modelling, extrapolated appeared be more useful describe early exposure infants, while extrapolation collected under regulators adults, failed capture absorption. Summary Substantial progress has been made developing an advanced suite streamlining formulation screening supporting applications. These advances achieved through networking opportunities research collaborations provided H2020 funded PEARRL project.