Identifying critical binder attributes to facilitate binder selection for efficient formulation development in a continuous twin screw wet granulation process
- Author
- Lise Vandevivere (UGent) , Maxine Vangampelaere (UGent) , Christoph Portier (UGent) , Cedrine de Backere (UGent) , Olaf Häusler, Thomas De Beer (UGent) , Chris Vervaet (UGent) and Valérie Vanhoorne
- Organization
- Abstract
- The suitability of pharmaceutical binders for continuous twin-screw wet granulation was investigated as the pharmaceutical industry is undergoing a switch from batch to continuous manufacturing. Binder selection for twin-screw wet granulation should rely on a scientific approach to enable efficient formulation development. Therefore, the current study identified binder attributes affecting the binder effectiveness in a wet granulation process of a highly soluble model excipient (mannitol). For this formulation, higher binder effectiveness was linked to fast activation of the binder properties (i.e., fast binder dissolution kinetics combined with low viscosity attributes and good wetting properties by the binder). As the impact of binder attributes on the granulation process of a poorly soluble formulation (dicalcium phosphate) was previously investigated, this enabled a comprehensive comparison between both formulations in current research focusing on binder selection. This comparison revealed that binder attributes that are important to guide binder selection differ in function of the solubility of the formulation. The identification of critical binder attributes in the current study enables rational and efficient binder selection for twin-screw granulation of well soluble and poorly soluble formulations. Binder addition proved especially valuable for a poorly soluble formulation.
- Keywords
- continuous manufacturing, wet granulation, twin-screw granulation, pharmaceutical binders, granule quality, tablet quality, formulation
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Citation
Please use this url to cite or link to this publication: http://hdl.handle.net/1854/LU-8692645
- MLA
- Vandevivere, Lise, et al. “Identifying Critical Binder Attributes to Facilitate Binder Selection for Efficient Formulation Development in a Continuous Twin Screw Wet Granulation Process.” PHARMACEUTICS, edited by Juan José Torrado, vol. 13, no. 2, 2021, doi:10.3390/pharmaceutics13020210.
- APA
- Vandevivere, L., Vangampelaere, M., Portier, C., de Backere, C., Häusler, O., De Beer, T., … Vanhoorne, V. (2021). Identifying critical binder attributes to facilitate binder selection for efficient formulation development in a continuous twin screw wet granulation process. PHARMACEUTICS, 13(2). https://doi.org/10.3390/pharmaceutics13020210
- Chicago author-date
- Vandevivere, Lise, Maxine Vangampelaere, Christoph Portier, Cedrine de Backere, Olaf Häusler, Thomas De Beer, Chris Vervaet, and Valérie Vanhoorne. 2021. “Identifying Critical Binder Attributes to Facilitate Binder Selection for Efficient Formulation Development in a Continuous Twin Screw Wet Granulation Process.” Edited by Juan José Torrado. PHARMACEUTICS 13 (2). https://doi.org/10.3390/pharmaceutics13020210.
- Chicago author-date (all authors)
- Vandevivere, Lise, Maxine Vangampelaere, Christoph Portier, Cedrine de Backere, Olaf Häusler, Thomas De Beer, Chris Vervaet, and Valérie Vanhoorne. 2021. “Identifying Critical Binder Attributes to Facilitate Binder Selection for Efficient Formulation Development in a Continuous Twin Screw Wet Granulation Process.” Ed by. Juan José Torrado. PHARMACEUTICS 13 (2). doi:10.3390/pharmaceutics13020210.
- Vancouver
- 1.Vandevivere L, Vangampelaere M, Portier C, de Backere C, Häusler O, De Beer T, et al. Identifying critical binder attributes to facilitate binder selection for efficient formulation development in a continuous twin screw wet granulation process. Torrado JJ, editor. PHARMACEUTICS. 2021;13(2).
- IEEE
- [1]L. Vandevivere et al., “Identifying critical binder attributes to facilitate binder selection for efficient formulation development in a continuous twin screw wet granulation process,” PHARMACEUTICS, vol. 13, no. 2, 2021.
@article{8692645,
abstract = {{The suitability of pharmaceutical binders for continuous twin-screw wet granulation was investigated as the pharmaceutical industry is undergoing a switch from batch to continuous manufacturing. Binder selection for twin-screw wet granulation should rely on a scientific approach to enable efficient formulation development. Therefore, the current study identified binder attributes affecting the binder effectiveness in a wet granulation process of a highly soluble model excipient (mannitol). For this formulation, higher binder effectiveness was linked to fast activation of the binder properties (i.e., fast binder dissolution kinetics combined with low viscosity attributes and good wetting properties by the binder). As the impact of binder attributes on the granulation process of a poorly soluble formulation (dicalcium phosphate) was previously investigated, this enabled a comprehensive comparison between both formulations in current research focusing on binder selection. This comparison revealed that binder attributes that are important to guide binder selection differ in function of the solubility of the formulation. The identification of critical binder attributes in the current study enables rational and efficient binder selection for twin-screw granulation of well soluble and poorly soluble formulations. Binder addition proved especially valuable for a poorly soluble formulation.}},
articleno = {{210}},
author = {{Vandevivere, Lise and Vangampelaere, Maxine and Portier, Christoph and de Backere, Cedrine and Häusler, Olaf and De Beer, Thomas and Vervaet, Chris and Vanhoorne, Valérie}},
editor = {{Torrado, Juan José}},
issn = {{1999-4923}},
journal = {{PHARMACEUTICS}},
keywords = {{continuous manufacturing,wet granulation,twin-screw granulation,pharmaceutical binders,granule quality,tablet quality,formulation}},
language = {{eng}},
number = {{2}},
pages = {{19}},
title = {{Identifying critical binder attributes to facilitate binder selection for efficient formulation development in a continuous twin screw wet granulation process}},
url = {{http://dx.doi.org/10.3390/pharmaceutics13020210}},
volume = {{13}},
year = {{2021}},
}
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