Integrating drug-and formulation-related properties with gastrointestinal tract variability using a product-specific particle size approach: case example ibuprofen
R Cristofoletti, B Hens, N Patel, VV Esteban… - Journal of …, 2019 - Elsevier
Journal of Pharmaceutical Sciences, 2019•Elsevier
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.
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.
Abstract
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.
Elsevier
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