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Microdynamic flowability for early API characterisation: A case study on Palbociclib.

David Blanco1, Nicolas Pätzmann2, Pablo García-Triñanes3

  • 1Division of Pharmaceutical Chemistry and Technology, University of Helsinki, Finland.

Pharmaceutical Science Advances
|January 19, 2026
PubMed
Summary

Early active pharmaceutical ingredient (API) characterisation using microdynamic flowability reveals how micronisation impacts powder flow. This method aids formulation development by assessing API processability under low-stress conditions.

Keywords:
API characterisationMicrodynamic powder flowabilityMicronisationParticle engineeringPre-formulation

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Chemical Engineering

Background:

  • Early characterisation of active pharmaceutical ingredients (APIs) is crucial due to compound scarcity and cost.
  • Understanding powder flowability is essential for successful formulation development and process design.
  • Micronisation can improve drug dissolution but may negatively impact powder flow properties.

Purpose of the Study:

  • To introduce microdynamic flowability as an innovative method for early API characterisation.
  • To investigate the effect of laboratory-scale micronisation on the flowability of Palbociclib.
  • To quantitatively describe powder agglomeration using minimal sample quantities.

Main Methods:

  • Utilisation of microdynamic flow measurements during the pre-formulation stage.
  • Laboratory-scale micronisation of a poorly water-soluble drug (Palbociclib).
  • Image analysis for quantitative description of agglomeration with <200 mg samples.

Main Results:

  • Micronisation of Palbociclib enhanced dissolution but adversely affected its flowability.
  • Cohesive forces leading to agglomeration were quantitatively described for the first time using image analysis.
  • Microdynamic flow studies provided critical insights into API processability under low-stress conditions.

Conclusions:

  • Microdynamic flow studies offer valuable insights into API processability, especially under research and development (R&D) conditions.
  • Advanced flowability analysis in early development improves understanding and control of powder processing.
  • This approach supports strategic decision-making in pharmaceutical manufacturing and particle engineering.