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Advantages of the refined developability classification system in early discovery.

Kristian Beran1, Jennifer Dressman2, Eline Hermans3

  • 1Fraunhofer Institute for Translational Medicine and Pharmacology, Frankfurt am Main, Germany; Janssen Pharmaceutica NV, Pharmaceutical & Material Sciences, Beerse, Belgium.

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Summary

This study compared rat oral drug exposures with the refined Developability Classification System (rDCS). The rDCS accurately predicted formulation strategies and bioavailability limits for active pharmaceutical ingredients (APIs).

Keywords:
Formulation selectionOral drug absorptionPharmacokinetic profilingRefined developability classification system (rDCS)

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Area of Science:

  • Pharmacokinetics and Drug Development
  • Pharmaceutical Sciences
  • Medicinal Chemistry

Background:

  • Rat pharmacokinetic studies are crucial for optimizing active pharmaceutical ingredients (APIs) during early drug discovery.
  • Understanding absorption, distribution, metabolism, and excretion (ADME) is key to successful API development.
  • The Developability Classification System (DCS) aids in predicting drug developability, but refinements are ongoing.

Purpose of the Study:

  • To compare in vivo rat oral exposures from suspension and solution formulations against the refined Developability Classification System (rDCS).
  • To evaluate the rDCS's utility in identifying oral absorption limitations and guiding formulation strategy selection for APIs.
  • To optimize oral bioavailability (BA) by leveraging physicochemical properties and predictive models.

Main Methods:

  • Utilized six diverse APIs with varying solubility, metabolic stability, and oral BA in rats.
  • Conducted fit-for-purpose oral suspension and solution pharmacokinetic studies in rats.
  • Applied the refined Developability Classification System (rDCS) for developability risk assessment.

Main Results:

  • Five of six APIs (acetaminophen, voriconazole, fedratinib, lemborexant, istradefylline) showed oral BA limited by first-pass metabolism in rats.
  • One API (voxelotor) demonstrated oral absorption limited by intestinal dissolution/solubility.
  • rDCS analysis provided a differentiated risk assessment, aligning well with clinical/marketed formulation strategies.

Conclusions:

  • The rDCS offers a valuable tool for predicting oral drug developability without preclinical data.
  • rDCS effectively incorporates compound physicochemical attributes and human physiology for risk assessment.
  • This approach aids in selecting appropriate formulation strategies and optimizing oral bioavailability early in drug discovery.