An Evaluation of Using Rat-Derived Single-Dose Neuropharmacokinetic Parameters to Project Accurately Large Animal Unbound Brain Drug Concentrations

Drug Metabolism and Disposition
2012.0

Abstract

Previous publications suggest that interstitial fluid compound concentrations (C(ISF)) best determine quantitative neurotherapeutic pharmacology relationships, although confirming large animal C(ISF) remains elusive. Therefore, this work primarily evaluated using respective acute dose, rat-derived unbound brain compound concentration-to-unbound plasma compound concentration ratios (C(b,u)/C(p,u)) to project accurately dog and nonhuman primate (nhp) C(b,u), a C(ISF) surrogate, from measured C(p,u) for the highly permeable non-P-glycoprotein substrates N-{(3R,4S)-3-[4-(5-cyano-2-thienyl)phenyl]tetrahydro-2H-pyran-4-yl}propane-2-sulfonamide (PF-4778574) and [4-chloro-5-fluoro-2-(3-methoxy-2-methyl-phenoxy)-benzyl]-methylamine (CE-157119) and the P-glycoprotein substrates risperidone and 9-hydroxyrisperidone. First, in rats, it was determined for eight of nine commercial compounds that their single-dose-derived C(b,u)/C(p,u) were ≤2.5-fold different from their steady-state values; for all nine drugs, their C(b,u)/C(p,u) were ≤2.5-fold different from their steady-state C(ISF)/C(p,u) (Drug Metab Dispos 37:787-793, 2009). Subsequently, PF-4778574, CE-157119 and risperidone underwent rat, dog, and nhp neuropharmacokinetics studies. In large animals at each measured C(p,u), the methodology adequately predicted [estimated mean (95% confidence interval) of 1.02 (0.80, 1.29)] the observed C(b,u) for PF-4778574 and CE-157119 but underpredicted [0.17 (0.12, 0.22)] C(b,u) for risperidone and 9-hydroxyrisperidone. The data imply that forecasting higher species C(b,u) from a measured C(p,u) and rat acute dose-determined C(b,u):C(p,u) is of high confidence for nonefflux transporter substrates that show net passive diffusion (PF-4778574) or net active influx (CE-157119) at the blood-brain barrier in rats. However, this methodology appears ineffective for correctly predicting large animal C(b,u) for P-glycoprotein substrates (risperidone and 9-hydroxyrisperidone) because of their apparently much greater C(p,u)-favoring C(b,u):C(p,u) asymmetry in rats versus dogs or nhp. Instead, for such P-glycoprotein substrates, large animal-specific cerebrospinal fluid compound concentrations (C(CSF)) seemingly best represent C(b,u).

Knowledge Graph

Similar Paper

An Evaluation of Using Rat-Derived Single-Dose Neuropharmacokinetic Parameters to Project Accurately Large Animal Unbound Brain Drug Concentrations
Drug Metabolism and Disposition 2012.0
Structure−Brain Exposure Relationships in Rat and Human Using a Novel Data Set of Unbound Drug Concentrations in Brain Interstitial and Cerebrospinal Fluids
Journal of Medicinal Chemistry 2009.0
A High-Throughput Cell-Based Method to Predict the Unbound Drug Fraction in the Brain
Journal of Medicinal Chemistry 2014.0
Measurement of Unbound Drug Exposure in Brain: Modeling of pH Partitioning Explains Diverging Results between the Brain Slice and Brain Homogenate Methods
Drug Metabolism and Disposition 2011.0
Species Independence in Brain Tissue Binding Using Brain Homogenates
Drug Metabolism and Disposition 2011.0
Brain Tissue Binding of Drugs: Evaluation and Validation of Solid Supported Porcine Brain Membrane Vesicles (TRANSIL) as a Novel High-Throughput Method
Drug Metabolism and Disposition 2011.0
Development of an In Silico Prediction Model for P-glycoprotein Efflux Potential in Brain Capillary Endothelial Cells toward the Prediction of Brain Penetration
Journal of Medicinal Chemistry 2021.0
Caco-2 permeability, P-glycoprotein transport ratios and brain penetration of heterocyclic drugs
International Journal of Pharmaceutics 2003.0
Human Pharmacokinetic Prediction of UDP-Glucuronosyltransferase Substrates with an Animal Scale-Up Approach
Drug Metabolism and Disposition 2011.0
High-Throughput Screening of Drug−Brain Tissue Binding and in Silico Prediction for Assessment of Central Nervous System Drug Delivery
Journal of Medicinal Chemistry 2007.0