
Evaluation of the influence of material properties and process parameters on granule porosity in twin-screw wet granulation
- Author
- Michiel Peeters (UGent) , Ana Alejandra Barrera Jiménez (UGent) , Kensaku Matsunami (UGent) , Fanny Stauffer, Ingmar Nopens (UGent) and Thomas De Beer (UGent)
- Organization
- Abstract
- In recent years, continuous twin-screw wet granulation (TSWG) is gaining increasing interest from the pharmaceutical industry. Despite the many publications on TSWG, only a limited number of studies focused on granule porosity, which was found to be an important granule property affecting the final tablet quality attributes, e.g. dissolution. In current study, the granule porosity along the length of the twin-screw granulator (TSG) barrel was evaluated. An experimental set-up was used allowing the collection of granules at the different TSG compartments. The effect of active pharmaceutical ingredient (API) properties on granule porosity was evaluated by using six formulations with a fixed composition but containing APIs with different physical–chemical properties. Furthermore, the importance of TSWG process parameters liquid-to-solid (L/S) ratio, mass feed rate and screw speed for the granule porosity was evaluated. Several water-related properties as well as particle size, density and flow properties of the API were found to have an important effect on granule porosity. While the L/S ratio was confirmed to be the dictating TSWG process parameter, granulator screw speed was also found to be an important process variable affecting granule porosity. This study obtained crucial information on the effect of material properties and process parameters on granule porosity (and granule formation) which can be used to accelerate TSWG process and formulation development.
- Keywords
- POPULATION BALANCE MODEL, CRITICAL QUALITY ATTRIBUTES, IMPACT, CONSOLIDATION, FORMULATION, PARTICLE, BATCH
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Citation
Please use this url to cite or link to this publication: http://hdl.handle.net/1854/LU-01H1KBG3F2TT19VWES7FHQEWAJ
- MLA
- Peeters, Michiel, et al. “Evaluation of the Influence of Material Properties and Process Parameters on Granule Porosity in Twin-Screw Wet Granulation.” INTERNATIONAL JOURNAL OF PHARMACEUTICS, vol. 641, 2023, doi:10.1016/j.ijpharm.2023.123010.
- APA
- Peeters, M., Barrera Jiménez, A. A., Matsunami, K., Stauffer, F., Nopens, I., & De Beer, T. (2023). Evaluation of the influence of material properties and process parameters on granule porosity in twin-screw wet granulation. INTERNATIONAL JOURNAL OF PHARMACEUTICS, 641. https://doi.org/10.1016/j.ijpharm.2023.123010
- Chicago author-date
- Peeters, Michiel, Ana Alejandra Barrera Jiménez, Kensaku Matsunami, Fanny Stauffer, Ingmar Nopens, and Thomas De Beer. 2023. “Evaluation of the Influence of Material Properties and Process Parameters on Granule Porosity in Twin-Screw Wet Granulation.” INTERNATIONAL JOURNAL OF PHARMACEUTICS 641. https://doi.org/10.1016/j.ijpharm.2023.123010.
- Chicago author-date (all authors)
- Peeters, Michiel, Ana Alejandra Barrera Jiménez, Kensaku Matsunami, Fanny Stauffer, Ingmar Nopens, and Thomas De Beer. 2023. “Evaluation of the Influence of Material Properties and Process Parameters on Granule Porosity in Twin-Screw Wet Granulation.” INTERNATIONAL JOURNAL OF PHARMACEUTICS 641. doi:10.1016/j.ijpharm.2023.123010.
- Vancouver
- 1.Peeters M, Barrera Jiménez AA, Matsunami K, Stauffer F, Nopens I, De Beer T. Evaluation of the influence of material properties and process parameters on granule porosity in twin-screw wet granulation. INTERNATIONAL JOURNAL OF PHARMACEUTICS. 2023;641.
- IEEE
- [1]M. Peeters, A. A. Barrera Jiménez, K. Matsunami, F. Stauffer, I. Nopens, and T. De Beer, “Evaluation of the influence of material properties and process parameters on granule porosity in twin-screw wet granulation,” INTERNATIONAL JOURNAL OF PHARMACEUTICS, vol. 641, 2023.
@article{01H1KBG3F2TT19VWES7FHQEWAJ, abstract = {{In recent years, continuous twin-screw wet granulation (TSWG) is gaining increasing interest from the pharmaceutical industry. Despite the many publications on TSWG, only a limited number of studies focused on granule porosity, which was found to be an important granule property affecting the final tablet quality attributes, e.g. dissolution. In current study, the granule porosity along the length of the twin-screw granulator (TSG) barrel was evaluated. An experimental set-up was used allowing the collection of granules at the different TSG compartments. The effect of active pharmaceutical ingredient (API) properties on granule porosity was evaluated by using six formulations with a fixed composition but containing APIs with different physical–chemical properties. Furthermore, the importance of TSWG process parameters liquid-to-solid (L/S) ratio, mass feed rate and screw speed for the granule porosity was evaluated. Several water-related properties as well as particle size, density and flow properties of the API were found to have an important effect on granule porosity. While the L/S ratio was confirmed to be the dictating TSWG process parameter, granulator screw speed was also found to be an important process variable affecting granule porosity. This study obtained crucial information on the effect of material properties and process parameters on granule porosity (and granule formation) which can be used to accelerate TSWG process and formulation development.}}, articleno = {{123010}}, author = {{Peeters, Michiel and Barrera Jiménez, Ana Alejandra and Matsunami, Kensaku and Stauffer, Fanny and Nopens, Ingmar and De Beer, Thomas}}, issn = {{0378-5173}}, journal = {{INTERNATIONAL JOURNAL OF PHARMACEUTICS}}, keywords = {{POPULATION BALANCE MODEL,CRITICAL QUALITY ATTRIBUTES,IMPACT,CONSOLIDATION,FORMULATION,PARTICLE,BATCH}}, language = {{eng}}, pages = {{12}}, title = {{Evaluation of the influence of material properties and process parameters on granule porosity in twin-screw wet granulation}}, url = {{http://doi.org/10.1016/j.ijpharm.2023.123010}}, volume = {{641}}, year = {{2023}}, }
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