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Identifying overarching excipient properties towards an in-depth understanding of process and product performance for continuous twin-screw wet granulation.
Int J Pharm. 2017 Apr 30; 522(1-2):234-247.IJ

Abstract

The overall objective of this work is to understand how excipient characteristics influence the process and product performance for a continuous twin-screw wet granulation process. The knowledge gained through this study is intended to be used for a Quality by Design (QbD)-based formulation design approach and formulation optimization. A total of 9 preferred fillers and 9 preferred binders were selected for this study. The selected fillers and binders were extensively characterized regarding their physico-chemical and solid state properties using 21 material characterization techniques. Subsequently, principal component analysis (PCA) was performed on the data sets of filler and binder characteristics in order to reduce the variety of single characteristics to a limited number of overarching properties. Four principal components (PC) explained 98.4% of the overall variability in the fillers data set, while three principal components explained 93.4% of the overall variability in the data set of binders. Both PCA models allowed in-depth evaluation of similarities and differences in the excipient properties.

Authors+Show Affiliations

Small Molecules Technical Development, F. Hoffmann-La Roche Ltd., Basel, Switzerland; Laboratory of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Ghent University, Belgium.Small Molecules Technical Development, F. Hoffmann-La Roche Ltd., Basel, Switzerland.Small Molecules Technical Development, F. Hoffmann-La Roche Ltd., Basel, Switzerland.Laboratory of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Ghent University, Belgium.Laboratory of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Ghent University, Belgium.Laboratory of Pharmaceutical Process Analytical Technology, Faculty of Pharmaceutical Sciences, Ghent University, Belgium. Electronic address: Thomas.DeBeer@Ugent.be.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

28213278

Citation

Willecke, N, et al. "Identifying Overarching Excipient Properties Towards an In-depth Understanding of Process and Product Performance for Continuous Twin-screw Wet Granulation." International Journal of Pharmaceutics, vol. 522, no. 1-2, 2017, pp. 234-247.
Willecke N, Szepes A, Wunderlich M, et al. Identifying overarching excipient properties towards an in-depth understanding of process and product performance for continuous twin-screw wet granulation. Int J Pharm. 2017;522(1-2):234-247.
Willecke, N., Szepes, A., Wunderlich, M., Remon, J. P., Vervaet, C., & De Beer, T. (2017). Identifying overarching excipient properties towards an in-depth understanding of process and product performance for continuous twin-screw wet granulation. International Journal of Pharmaceutics, 522(1-2), 234-247. https://doi.org/10.1016/j.ijpharm.2017.02.028
Willecke N, et al. Identifying Overarching Excipient Properties Towards an In-depth Understanding of Process and Product Performance for Continuous Twin-screw Wet Granulation. Int J Pharm. 2017 Apr 30;522(1-2):234-247. PubMed PMID: 28213278.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Identifying overarching excipient properties towards an in-depth understanding of process and product performance for continuous twin-screw wet granulation. AU - Willecke,N, AU - Szepes,A, AU - Wunderlich,M, AU - Remon,J P, AU - Vervaet,C, AU - De Beer,T, Y1 - 2017/02/14/ PY - 2016/12/13/received PY - 2017/02/09/revised PY - 2017/02/10/accepted PY - 2017/2/19/pubmed PY - 2017/8/17/medline PY - 2017/2/19/entrez KW - Continuous twin-screw wet granulation KW - Excipient characterization KW - Multivariate data analysis KW - Principal component analysis (PCA) KW - Quality by Design (QbD) SP - 234 EP - 247 JF - International journal of pharmaceutics JO - Int J Pharm VL - 522 IS - 1-2 N2 - The overall objective of this work is to understand how excipient characteristics influence the process and product performance for a continuous twin-screw wet granulation process. The knowledge gained through this study is intended to be used for a Quality by Design (QbD)-based formulation design approach and formulation optimization. A total of 9 preferred fillers and 9 preferred binders were selected for this study. The selected fillers and binders were extensively characterized regarding their physico-chemical and solid state properties using 21 material characterization techniques. Subsequently, principal component analysis (PCA) was performed on the data sets of filler and binder characteristics in order to reduce the variety of single characteristics to a limited number of overarching properties. Four principal components (PC) explained 98.4% of the overall variability in the fillers data set, while three principal components explained 93.4% of the overall variability in the data set of binders. Both PCA models allowed in-depth evaluation of similarities and differences in the excipient properties. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/28213278/Identifying_overarching_excipient_properties_towards_an_in_depth_understanding_of_process_and_product_performance_for_continuous_twin_screw_wet_granulation_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(17)30109-6 DB - PRIME DP - Unbound Medicine ER -