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Related Experiment Video

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Application of Dixon's Up-and-Down Design to Estimate the Minimum Alveolar Concentration of Sevoflurane in Rats with Refined Movement Classification
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Application of a Refined Developability Classification System.

Julian Rosenberger1, James Butler2, Uwe Muenster3

  • 1Institute of Pharmaceutical Technology, Goethe University Frankfurt, Frankfurt am Main, Germany.

Journal of Pharmaceutical Sciences
|November 4, 2018
PubMed
Summary
This summary is machine-generated.

The refined Developability Classification System (rDCS) accurately predicts oral drug formulation behavior. This system aids early drug candidate evaluation by assessing solubility and permeability, improving in vivo predictions.

Keywords:
Biopharmaceutics Classification System (BCS)dissolutionformulationhigh throughput technologiesin vitro modelsoral absorptionpermeation enhancerssolubilitysupersaturation

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Development
  • Biopharmaceutics

Background:

  • The Biopharmaceutics Classification System (BCS) aids drug development.
  • The Developability Classification System (DCS) was introduced in 2010 for early oral formulation evaluation.
  • The refined Developability Classification System (rDCS) builds upon the DCS with enhanced investigations.

Purpose of the Study:

  • To validate the refined Developability Classification System (rDCS) using marketed drugs.
  • To assess the predictive power of the rDCS for new drug candidates in development.
  • To evaluate the rDCS's utility in predicting in vivo drug behavior.

Main Methods:

  • Applied the rDCS framework to six well-characterized marketed compounds.
  • Utilized the rDCS for 20 pipeline drug candidates from Bayer AG research.
  • Conducted standard and customized investigations for solubility, permeability, and supersaturation/precipitation potential.

Main Results:

  • The rDCS successfully classified marketed compounds based on available data.
  • The rDCS accurately predicted human in vivo outcomes for 80% of pipeline compounds.
  • The system identified potential issues like supersaturation/precipitation and absorption limitations.

Conclusions:

  • The refined Developability Classification System (rDCS) is a valuable tool for early drug candidate assessment.
  • The rDCS enhances the prediction of oral drug formulation developability and in vivo performance.
  • This approach supports efficient drug development by identifying potential challenges early.