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Continuous twin screw granulation and fluid bed drying: A mechanistic scaling approach focusing optimal tablet properties.
Int J Pharm. 2020 Aug 30; 586:119509.IJ

Abstract

This study provides the results of investigation on scaling approaches for three differently-sized continuous granulation lines, each consisting of a twin screw wet granulation process and a continuous fluid bed drying process. To check the initial scaling approach with regard to granule and tablet properties, a process parameter Design of experiment (DoE) was performed on each of the three equipment scales. The processed formulation did not contain cellulose to allow a high overall flowrate through the directly connected granulation and drying sections. Enhanced scaling aspects showed the influence of Froude number [-] at different twin screw granulator scales and screw speeds on the overgranulated particle fraction [% (V/V] as well as on the scale-dependent drying performance of the continuous fluid bed dryers. Scale-independent, specification limits of the two granule material attributes particle fine fraction [%] and residual water content [%] could be defined, resulting in high tableting performance in terms of tabletability and compressibility. Based on these specification limits and the statistical evaluation of the process parameter DoE, a process design space for the continuous granulation and drying process for each scale was calculated. It came up, that this process design space was decreasing in range with increasing equipment scale. The applicability of the presented scaling approach in terms of granule and tablet properties could successfully be demonstrated by three control experiments performed on the different equipment scales. In sum, this work delivers a basis for a smooth transition of scales within process development on the investigated continuous twin screw granulation and drying lines.

Authors+Show Affiliations

Pharmaceutical Development, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Straβe 65, 88397 Biberach, Germany; Department of Pharmaceutical Technology, University of Bonn, Gerhard-Domagk-Straβe 3, 53121 Bonn, Germany.Pharmaceutical Development, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Straβe 65, 88397 Biberach, Germany.Department of Pharmaceutical Technology, University of Bonn, Gerhard-Domagk-Straβe 3, 53121 Bonn, Germany. Electronic address: karl.wagner@uni-bonn.de.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32561305

Citation

Menth, Judith, et al. "Continuous Twin Screw Granulation and Fluid Bed Drying: a Mechanistic Scaling Approach Focusing Optimal Tablet Properties." International Journal of Pharmaceutics, vol. 586, 2020, p. 119509.
Menth J, Maus M, Wagner KG. Continuous twin screw granulation and fluid bed drying: A mechanistic scaling approach focusing optimal tablet properties. Int J Pharm. 2020;586:119509.
Menth, J., Maus, M., & Wagner, K. G. (2020). Continuous twin screw granulation and fluid bed drying: A mechanistic scaling approach focusing optimal tablet properties. International Journal of Pharmaceutics, 586, 119509. https://doi.org/10.1016/j.ijpharm.2020.119509
Menth J, Maus M, Wagner KG. Continuous Twin Screw Granulation and Fluid Bed Drying: a Mechanistic Scaling Approach Focusing Optimal Tablet Properties. Int J Pharm. 2020 Aug 30;586:119509. PubMed PMID: 32561305.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Continuous twin screw granulation and fluid bed drying: A mechanistic scaling approach focusing optimal tablet properties. AU - Menth,Judith, AU - Maus,Martin, AU - Wagner,Karl G, Y1 - 2020/06/16/ PY - 2020/03/05/received PY - 2020/06/02/revised PY - 2020/06/03/accepted PY - 2020/6/21/pubmed PY - 2021/3/4/medline PY - 2020/6/21/entrez KW - Continuous fluid-bed drying KW - Continuous manufacturing KW - Granulation KW - Process scaling KW - Tablet attributes KW - Twin screw granulation SP - 119509 EP - 119509 JF - International journal of pharmaceutics JO - Int J Pharm VL - 586 N2 - This study provides the results of investigation on scaling approaches for three differently-sized continuous granulation lines, each consisting of a twin screw wet granulation process and a continuous fluid bed drying process. To check the initial scaling approach with regard to granule and tablet properties, a process parameter Design of experiment (DoE) was performed on each of the three equipment scales. The processed formulation did not contain cellulose to allow a high overall flowrate through the directly connected granulation and drying sections. Enhanced scaling aspects showed the influence of Froude number [-] at different twin screw granulator scales and screw speeds on the overgranulated particle fraction [% (V/V] as well as on the scale-dependent drying performance of the continuous fluid bed dryers. Scale-independent, specification limits of the two granule material attributes particle fine fraction [%] and residual water content [%] could be defined, resulting in high tableting performance in terms of tabletability and compressibility. Based on these specification limits and the statistical evaluation of the process parameter DoE, a process design space for the continuous granulation and drying process for each scale was calculated. It came up, that this process design space was decreasing in range with increasing equipment scale. The applicability of the presented scaling approach in terms of granule and tablet properties could successfully be demonstrated by three control experiments performed on the different equipment scales. In sum, this work delivers a basis for a smooth transition of scales within process development on the investigated continuous twin screw granulation and drying lines. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/32561305/Continuous_twin_screw_granulation_and_fluid_bed_drying:_A_mechanistic_scaling_approach_focusing_optimal_tablet_properties_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(20)30493-2 DB - PRIME DP - Unbound Medicine ER -