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

Abstract

This study explores microdynamic flowability as an innovative approach for early active pharmaceutical ingredient (API) characterisation, when compounds are often scarce and/or expensive. By incorporating small-scale flow measurements during the pre-formulation stage, we aim to support strategic decision-making in formulation development and process design. Laboratory-scale micronisation of the poorly water-soluble drug Palbociclib, while enhancing dissolution, was found to adversely affect flowability. Agglomeration driven by cohesive forces was quantitatively described for the first time via image analysis using sample quantities of less than 200 mg. Our findings demonstrate that microdynamic flow studies provide critical insights into the processability of APIs under low-stress conditions, such as those relevant to research and development (R&D) tablet presses. These results highlight the value of advanced flowability analysis in early-stage development, enabling improved understanding and control of powder processing in pharmaceutical manufacturing and particle engineering.

Keywords

API characterization / Microdynamic powder flowability / Micronisation / Pre-formulation / Particle engineering

CRediT authorship contribution statement

David Blanco: Writing - original draft, Methodology, Investigation, Conceptualization. Nicolas Pätzmann: Methodology, Investigation, Conceptualization. Pablo García-Triñanes: Writing - review & editing, Resources.

Data availability

Data supporting the findings of this study are available upon request from the corresponding author.

Ethics approval

Not applicable.

Declaration of generative AI in scientific writing

Not applicable.

Funding information

This work was funded by the Finnish Cultural Foundation -Suomen Kulttuurirahasto Foundation- [2024] and the innovation program under the Marie Skłodowska-Curie (No. 778051, 2022). P.G.T was supported by a Beatriz Galindo Senior Fellowship from the Spanish Ministry of Science, Innovation and Universities.

Declaration of competing interest

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Acknowledgements

Not applicable.

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