The pH-dependent solubility of weak bases poses unique biopharmaceutics questions for their clinical assessment. A weak base compound is generally expected to solubilize in the acidic stomach due to favorable solubility. The potential precipitation during transition from the stomach to the intestine can raise questions on adequate bioavailability in early clinical studies. Furthermore, the solubility differential between low and high pH may result in drug-drug interactions with commonly administered acid reducing agents, which can have implications both on clinical trial designs as well as the final product label. Finally the pH-dependent solubility may also impact the absorption behavior when dosed with food. This talk will focus on the clinical experience with weak base compounds as it relates to their absorption behavior, formulation selection and clinical investigation of DDIs. Translational aspects from preclinical to clinical settings will be discussed, focusing on the utilization of PBPK modeling.

Clinical and translational biopharmaceutics considerations for weak bases

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