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Integrating Drug- and Formulation-Related Properties With Gastrointestinal Tract Variability Using a Product-Specific Particle Size Approach

Case Example Ibuprofen
: Cristofoletti, R.; Hens, B.; Patel, N.; Esteban, V.V.; Schmidt, S.; Dressman, J.


Journal of pharmaceutical sciences (2019)
ISSN: 0022-3549
ISSN: 1520-6017
Fraunhofer IME ()

In the present study, an in vitro–in vivo extrapolation of dissolution integrated to a physiologically based pharmacokinetics modeling approach, considering a product-specific particle size distribution and a self-buffering effect of the drug, is introduced and appears to be a promising translational modeling strategy to support drug product development, manufacturing changes and setting clinically relevant specifications for immediate release formulations containing ibuprofen and other weak acids with similar properties.