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Structured solubility behaviour in fed simulated intestinal fluids.

Maria Inês Silva1, Ibrahim Khadra1, Kate Pyper2

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Summary
This summary is machine-generated.

This study assessed drug solubility in simulated intestinal fluids, finding that two specific media can predict maximum and minimum solubility for most drugs. This offers a new in vitro method for rational drug development decisions.

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Area of Science:

  • Pharmacokinetics and Drug Metabolism
  • Physical Chemistry of Drugs
  • Formulation Science

Background:

  • Intestinal drug solubility is critical for oral drug absorption.
  • Current in vitro methods for measuring fed-state solubility lack consensus on optimal simulated intestinal fluid recipes.
  • Significant compositional variability exists in fed human intestinal fluid.

Purpose of the Study:

  • To assess the solubility behavior of 24 diverse drugs across nine bioequivalent simulated fed intestinal media.
  • To determine if structured solubility patterns exist and correlate with drug physicochemical properties.
  • To identify a minimal set of media that can predict in vitro drug solubility ranges.

Main Methods:

  • Utilized nine bioequivalent simulated fed intestinal media recipes reflecting human intestinal fluid variability.
  • Assessed the solubility of 24 drugs (acidic, basic, neutral) in these media.
  • Categorized drug solubility behavior based on media composition (pH, total amphiphile concentration).

Main Results:

  • Drug solubility behavior was categorized into four distinct groups.
  • For acidic drugs, solubility was primarily pH-dependent.
  • For weakly acidic, basic, and neutral drugs, solubility depended on both pH and total amphiphile concentration (TAC).
  • Two specific media were identified as capable of predicting maximum and minimum solubility for the majority of drugs.
  • Four drugs showed minimal solubility variation, and three drugs exhibited atypical behavior.

Conclusions:

  • A structured solubility behavior is evident across different drug classes in simulated fed intestinal media.
  • The use of two optimized bioequivalent media can effectively predict in vitro drug solubility ranges.
  • This approach, combined with fasted-state data, enables Quality by Design decisions for rational drug and formulation development.
  • The multi-dimensional media system shows promise as an in vitro tool for assessing fed intestinal solubility.