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Structured solubility behaviour in bioequivalent fasted simulated intestinal fluids.

Qamar Abuhassan1, Ibrahim Khadra1, Kate Pyper2

  • 1Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow G4 0RE, United Kingdom.

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Summary
This summary is machine-generated.

This study evaluated drug solubility in nine bioequivalent simulated intestinal fluids. The findings show these media can predict in vivo drug solubility ranges, aiding drug development.

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Area of Science:

  • Pharmacology
  • Drug Discovery
  • Physical Chemistry

Background:

  • Drug solubility in intestinal fluid is critical for oral absorption.
  • Existing in vitro simulated intestinal fluids lack standardized recipes, hindering research.
  • A previous study developed nine bioequivalent intestinal media representing 90% of compositional variability.

Purpose of the Study:

  • To assess the equilibrium solubility of 21 exemplar drugs using the nine bioequivalent intestinal media.
  • To determine if consistent solubility behavior is observed across these drugs and media.
  • To evaluate the utility of these media for predicting in vivo drug solubility and aiding drug development decisions.

Main Methods:

  • Equilibrium solubility of 21 drugs was measured in nine bioequivalent fasted intestinal media.
  • Drug solubility behavior was analyzed in relation to physicochemical properties (pKa) and media composition (pH, total amphiphile concentration).
  • The ability of extreme media conditions to define solubility boundaries was assessed.

Main Results:

  • Bioequivalent media demonstrated structured and consistent solubility behavior for most drugs.
  • Acidic drugs' solubility was primarily pH-dependent, with extreme pH media identifying solubility limits.
  • Weakly acidic, basic, and neutral drugs showed solubility influenced by pH and total amphiphile concentration, with extreme conditions defining boundaries in over 78% of cases.
  • A subset of neutral drugs exhibited minimal solubility variation.
  • Two drugs, probucol and atazanavir, displayed unusual solubility behavior.

Conclusions:

  • Two selected bioequivalent fasted intestinal media can effectively define in vitro maximum and minimum drug solubility boundaries.
  • These media offer a reliable in vitro method for predicting in vivo drug solubility ranges.
  • The developed media can assist in drug discovery and development by rationalizing drug and formulation decisions and aiding Biopharmaceutics Classification System (BCS)/Drug Classification System (DCS) placement.