RT journal article
T1 Microdynamic flowability for early API characterisation: A case study on Palbociclib
A1 Blanco, David
A1 Pätzmann, Nicolas
A1 García Trinanes, Pablo
A2 Ingeniería Química y Tecnología de Alimentos
K1 API characterisation
K1 Microdynamic powder flowability
K1 Micronisation
K1 Pre-formulation
K1 Particle engineering
AB 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 f low 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.
PB Elservier
SN 2773-2169
YR 2025
FD 2025-03-11
LK http://hdl.handle.net/10498/38030
UL http://hdl.handle.net/10498/38030
LA eng
DS Repositorio Institucional de la Universidad de Cádiz
RD 06-nov-2026