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      Identifying overarching excipient properties towards an in-depth understanding of process and product performance for continuous twin-screw wet granulation.

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          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.

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          Author and article information

          Journal
          Int J Pharm
          International journal of pharmaceutics
          Elsevier BV
          1873-3476
          0378-5173
          Apr 30 2017
          : 522
          : 1-2
          Affiliations
          [1 ] Small Molecules Technical Development, F. Hoffmann-La Roche Ltd., Basel, Switzerland; Laboratory of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Ghent University, Belgium.
          [2 ] Small Molecules Technical Development, F. Hoffmann-La Roche Ltd., Basel, Switzerland.
          [3 ] Laboratory of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Ghent University, Belgium.
          [4 ] Laboratory of Pharmaceutical Process Analytical Technology, Faculty of Pharmaceutical Sciences, Ghent University, Belgium. Electronic address: Thomas.DeBeer@Ugent.be.
          Article
          S0378-5173(17)30109-6
          10.1016/j.ijpharm.2017.02.028
          28213278
          c1a2290f-73e4-4360-8457-def48f92a006
          History

          Principal component analysis (PCA),Multivariate data analysis,Continuous twin-screw wet granulation,Quality by Design (QbD),Excipient characterization

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