Quantitative investigation of particle formation of a model pharmaceutical formulation using single droplet evaporation experiments and X-ray tomography

Research output: Contribution to journalArticle

Abstract

The implementation of a particle design platform that can be applied to novel pharmaceutical systems using acoustic levitation (SAL) and X-ray tomography (XRT) is discussed. Acoustic levitation was employed to provide a container-less particle design environment for single droplet evaporation experiments. Dried particles were subject to further visual and quantitative structural analysis using X-ray tomography to assess the three-dimensional volume space. The workflow of the combined SAL-XRT platform has been applied to investigate the impact of increasing HPMC K100LV concentrations on the evaporation, drying and final particle morphology of particles from a model pharmaceutical formulation containing metformin and D-mannitol. The morphology and internal structure of the formulated particles after drying are dominated by a crystalline core of D-mannitol partially suppressed with increasing HPMC K100LV additions. The final structure can be correlated to the observed evaporation kinetics. The characterisation and its influence on the final particle morphology can enable the selection of process conditions that deliver the desired particle structure and consequent performance by design.
LanguageEnglish
Number of pages11
JournalAdvanced Powder Technology
Early online date12 Oct 2018
DOIs
Publication statusE-pub ahead of print - 12 Oct 2018

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X Ray Tomography
Drug Compounding
Acoustics
Drug products
Tomography
Evaporation
Mannitol
X rays
Drying
Environment Design
Pharmaceutical Preparations
Workflow
Metformin
Experiments
Structural analysis
Containers
Crystalline materials
Kinetics

Keywords

  • pharmaceutical formulation development
  • acoustic levitation
  • crystallisation
  • XRT particle structure analysis
  • single droplet evaporation

Cite this

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title = "Quantitative investigation of particle formation of a model pharmaceutical formulation using single droplet evaporation experiments and X-ray tomography",
abstract = "The implementation of a particle design platform that can be applied to novel pharmaceutical systems using acoustic levitation (SAL) and X-ray tomography (XRT) is discussed. Acoustic levitation was employed to provide a container-less particle design environment for single droplet evaporation experiments. Dried particles were subject to further visual and quantitative structural analysis using X-ray tomography to assess the three-dimensional volume space. The workflow of the combined SAL-XRT platform has been applied to investigate the impact of increasing HPMC K100LV concentrations on the evaporation, drying and final particle morphology of particles from a model pharmaceutical formulation containing metformin and D-mannitol. The morphology and internal structure of the formulated particles after drying are dominated by a crystalline core of D-mannitol partially suppressed with increasing HPMC K100LV additions. The final structure can be correlated to the observed evaporation kinetics. The characterisation and its influence on the final particle morphology can enable the selection of process conditions that deliver the desired particle structure and consequent performance by design.",
keywords = "pharmaceutical formulation development, acoustic levitation, crystallisation, XRT particle structure analysis, single droplet evaporation",
author = "Doerr, {Frederik J.S.} and Oswald, {Iain D.H.} and Florence, {Alastair J.}",
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N2 - The implementation of a particle design platform that can be applied to novel pharmaceutical systems using acoustic levitation (SAL) and X-ray tomography (XRT) is discussed. Acoustic levitation was employed to provide a container-less particle design environment for single droplet evaporation experiments. Dried particles were subject to further visual and quantitative structural analysis using X-ray tomography to assess the three-dimensional volume space. The workflow of the combined SAL-XRT platform has been applied to investigate the impact of increasing HPMC K100LV concentrations on the evaporation, drying and final particle morphology of particles from a model pharmaceutical formulation containing metformin and D-mannitol. The morphology and internal structure of the formulated particles after drying are dominated by a crystalline core of D-mannitol partially suppressed with increasing HPMC K100LV additions. The final structure can be correlated to the observed evaporation kinetics. The characterisation and its influence on the final particle morphology can enable the selection of process conditions that deliver the desired particle structure and consequent performance by design.

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KW - pharmaceutical formulation development

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KW - single droplet evaporation

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