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Drug transporters are critical in drug absorption, distribution, and excretion processes. They should be included in physiological-based pharmacokinetic (PBPK) models, which help predict human drug disposition. However, predicting this is challenging during drug development, especially when liver transport is involved. However, with a realistic representation of body transport processes, an accurate model may be possible.
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Drug clearance is a critical pharmacokinetic process involving the irreversible removal of drugs from the body through various organs over a specified time period. Physiological models are indispensable in determining organ-specific clearance, defined by the proportion of the drug eliminated per unit of time from the organ's blood volume.
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In pharmacotherapy, monitoring drug concentrations is paramount, especially for drugs whose therapeutic effects hinge on both the active compound and its metabolite. Hepatic impairment profoundly influences drug potency by altering liver function. If the drug is more potent than its metabolite, impaired liver function amplifies drug activity due to elevated drug concentration levels. Conversely, if the metabolite holds greater potency, diminished liver function diminishes drug activity by...
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Human Liver Microphysiological System for Assessing Drug-Induced Liver Toxicity In Vitro
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Pharmaceutical Metabolism in Fish: Using a 3-D Hepatic In Vitro Model to Assess Clearance.

Matthew G Baron1,2, Kate S Mintram1,2, Stewart F Owen2

  • 1School of Biological Science, Plymouth University, Devon, United Kingdom.

Plos One
|January 4, 2017
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Summary

Rainbow trout liver spheroids effectively metabolize certain pharmaceuticals like propranolol and diclofenac. This 3-D in vitro model aids environmental risk assessment by measuring xenobiotic metabolism, reducing animal testing.

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Area of Science:

  • Environmental toxicology
  • Fish ecotoxicology
  • In vitro models

Background:

  • Pharmaceuticals in aquatic environments pose risks due to bioaccumulation and potential pharmacological effects.
  • Environmental risk assessment for pharmaceuticals in fish requires understanding their metabolism.
  • In vitro methods are needed to reduce animal testing for ecotoxicological evaluations.

Purpose of the Study:

  • To evaluate a 3-D rainbow trout liver organoid (spheroid) culture system for assessing pharmaceutical metabolism.
  • To determine the metabolic competence of trout liver spheroids for xenobiotics.
  • To compare in vitro metabolic clearance data with existing in vivo or in vitro data.

Main Methods:

  • Utilized a 3-D rainbow trout liver spheroid culture system.
  • Employed a substrate depletion assay to measure the metabolism of seven model pharmaceuticals.
  • Calculated intrinsic hepatic clearance from substrate depletion kinetics data.

Main Results:

  • Trout liver spheroids metabolized propranolol, diclofenac, and phenylbutazone.
  • Atenolol, metoprolol, diazepam, and carbamazepine were not significantly metabolized.
  • Estimated intrinsic hepatic clearance for propranolol and diclofenac using spheroids showed comparability with other methods, with propranolol clearance being approximately 5-fold higher than S9 data.

Conclusions:

  • Rainbow trout liver spheroids represent a metabolically competent in vitro model for fish pharmaceutical biotransformation studies.
  • This spheroid system can aid in ecotoxicological risk assessment of pharmaceuticals.
  • Propranolol serves as a reliable positive control for this in vitro assay.