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Utilizing Flux to Inform Formulation Strategy Decisions in Preclinical Studies.

Laura I Mosquera-Giraldo1, Zina Patel2, Dongyue Yu2

  • 1Pharmaceutical Candidate Optimization, Bristol Myers Squibb, 10300 Campus Point Drive Suite 100, San Diego, California 92121, United States.

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Summary
This summary is machine-generated.

Flux assays are crucial for selecting optimal drug formulations and explaining in vivo exposure variations. This study provides a framework for using flux measurements, comparing diffusion setups, and correlating in vitro results with in vivo data.

Keywords:
96-wellPermeaPadPionamorphous solid dispersioncyclodextrinfluxformulationsin vivo exposuresμFLUX

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery
  • Preclinical Research

Background:

  • Flux experiments are vital in preclinical drug development for formulation selection, determining use-times for supersaturating systems, and understanding in vivo exposure variability.
  • Identifying optimal formulations requires robust methods to assess drug permeation and predict in vivo performance.

Purpose of the Study:

  • To establish a decision-making framework for identifying optimal drug formulations based on in vitro flux measurements.
  • To compare the utility and limitations of two different diffusion setups: 96-well PermeaPad plates and the Pion μFLUX diffusion system.
  • To correlate in vitro flux data with in vivo exposure data in animal models.

Main Methods:

  • Evaluated five internal model compounds using flux experiments in two diffusion systems: 96-well PermeaPad plates and Pion μFLUX.
  • Assessed drug concentrations in the receiver compartment using mass spectrometry.
  • Investigated the influence of amorphous solubility and MDCK passive permeability on assay detectability.

Main Results:

  • The 96-well PermeaPad system proved inadequate for certain compounds due to undetectable receiver concentrations, necessitating a shift to the larger Pion μFLUX system.
  • Amorphous solubility and MDCK passive permeability were critical factors in determining the success of the PermeaPad assay.
  • A strong correlation was observed between in vitro flux experiments and in vivo exposures in animal species, highlighting limitations of dissolution data alone.

Conclusions:

  • Flux assays are essential tools for screening formulations and elucidating formulation-dependent differences observed in vivo.
  • The Pion μFLUX system, coupled with mass spectrometry, offers a reliable method for flux measurements when PermeaPad plates are insufficient.
  • Integrating flux data provides a more comprehensive understanding of drug performance compared to dissolution data alone.