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TPLS as predictive platform for twin-screw wet granulation process and formulation development.
Int J Pharm. 2021 Aug 10; 605:120785.IJ

Abstract

In recent years, the interest in continuous manufacturing techniques, such as twin-screw wet granulation, has increased. However, the understanding of the influence of the combination of raw material properties and process settings upon the granule quality attributes is still limited. In this study, a T-shaped partial least squares (TPLS) model was developed to link raw material properties, the ratios in which these raw materials were combined and the applied process parameters for the twin-screw wet granulation process with the granule quality attributes. In addition, the predictive ability of the TPLS model was used to find a suitable combination of formulation composition and twin-screw granulation process settings for a new API leading to desired granule quality attributes. Overall, this study helped to better understand the link between raw material properties, formulation composition and process settings on granule quality attributes. Moreover, as TPLS can provide a reasonable starting point for formulation and process development for new APIs, it can reduce the experimental development efforts and consequently the consumption of expensive (and often limited available) new API.

Authors+Show Affiliations

Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical analysis, Ghent University, Ottergemsesteenweg 460, 9000 Ghent, Belgium. Electronic address: AlexanderJ.Ryckaert@UGent.be.Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical analysis, Ghent University, Ottergemsesteenweg 460, 9000 Ghent, Belgium; BIOMATH, Department of Mathematical Modelling, Statistics and Bio-informatics, Ghent University, Coupure Links 653, 9000 Ghent, Belgium. Electronic address: Daan.VanHauwermeiren@UGent.be.Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical analysis, Ghent University, Ottergemsesteenweg 460, 9000 Ghent, Belgium. Electronic address: JensJ.Dhondt@UGent.be.Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical analysis, Ghent University, Ottergemsesteenweg 460, 9000 Ghent, Belgium. Electronic address: Alexander.DeMan@UGent.be.Chemical & Pharmaceutical Development, Pharma R&D, Bayer AG, Friedrich-Ebert-Straβe 475, 42369 Wuppertal, Germany. Electronic address: Adrian.Funke@bayer.com.Chemical & Pharmaceutical Development, Pharma R&D, Bayer AG, Friedrich-Ebert-Straβe 475, 42369 Wuppertal, Germany. Electronic address: Dejan.Djuric@bayer.com.Laboratory of Pharmaceutical Technology, Department of Pharmaceutics Ghent University, Ottergemsesteenweg 460, Ghent, Belgium. Electronic address: Chris.Vervaet@UGent.be.BIOMATH, Department of Mathematical Modelling, Statistics and Bio-informatics, Ghent University, Coupure Links 653, 9000 Ghent, Belgium. Electronic address: Ingmar.Nopens@ugent.be.Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical analysis, Ghent University, Ottergemsesteenweg 460, 9000 Ghent, Belgium. Electronic address: Thomas.DeBeer@UGent.be.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

34111548

Citation

Ryckaert, A, et al. "TPLS as Predictive Platform for Twin-screw Wet Granulation Process and Formulation Development." International Journal of Pharmaceutics, vol. 605, 2021, p. 120785.
Ryckaert A, Van Hauwermeiren D, Dhondt J, et al. TPLS as predictive platform for twin-screw wet granulation process and formulation development. Int J Pharm. 2021;605:120785.
Ryckaert, A., Van Hauwermeiren, D., Dhondt, J., De Man, A., Funke, A., Djuric, D., Vervaet, C., Nopens, I., & De Beer, T. (2021). TPLS as predictive platform for twin-screw wet granulation process and formulation development. International Journal of Pharmaceutics, 605, 120785. https://doi.org/10.1016/j.ijpharm.2021.120785
Ryckaert A, et al. TPLS as Predictive Platform for Twin-screw Wet Granulation Process and Formulation Development. Int J Pharm. 2021 Aug 10;605:120785. PubMed PMID: 34111548.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - TPLS as predictive platform for twin-screw wet granulation process and formulation development. AU - Ryckaert,A, AU - Van Hauwermeiren,D, AU - Dhondt,J, AU - De Man,A, AU - Funke,A, AU - Djuric,D, AU - Vervaet,C, AU - Nopens,I, AU - De Beer,T, Y1 - 2021/06/08/ PY - 2021/05/04/received PY - 2021/06/03/revised PY - 2021/06/04/accepted PY - 2021/6/11/pubmed PY - 2021/8/4/medline PY - 2021/6/10/entrez KW - Continuous manufacturing KW - Formulation development KW - Process understanding KW - Twin-screw granulation SP - 120785 EP - 120785 JF - International journal of pharmaceutics JO - Int J Pharm VL - 605 N2 - In recent years, the interest in continuous manufacturing techniques, such as twin-screw wet granulation, has increased. However, the understanding of the influence of the combination of raw material properties and process settings upon the granule quality attributes is still limited. In this study, a T-shaped partial least squares (TPLS) model was developed to link raw material properties, the ratios in which these raw materials were combined and the applied process parameters for the twin-screw wet granulation process with the granule quality attributes. In addition, the predictive ability of the TPLS model was used to find a suitable combination of formulation composition and twin-screw granulation process settings for a new API leading to desired granule quality attributes. Overall, this study helped to better understand the link between raw material properties, formulation composition and process settings on granule quality attributes. Moreover, as TPLS can provide a reasonable starting point for formulation and process development for new APIs, it can reduce the experimental development efforts and consequently the consumption of expensive (and often limited available) new API. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/34111548/TPLS_as_predictive_platform_for_twin_screw_wet_granulation_process_and_formulation_development_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(21)00590-1 DB - PRIME DP - Unbound Medicine ER -