title: Prediction of solid fraction from powder mixtures based on single component compression analysis.
abstract: The aim of this study was to provide a systematic evaluation of various compression models (Percolation, Kawakita, Exponential model) in respect to predict tablet́s solid fraction for direct compression mixtures, based on single component compression analysis. Four mixtures were compressed over a wide pressure range at various fractions of microcrystalline cellulose (MCC) and pre-agglomerated lactose monohydrate (LAC) to compare an adjusted Percolation, Kawakita and a simple Exponential model. Based on single compression analysis of the pure excipients and application of these models, it was possible to predict the solid fraction of all mixtures. The Kawakita model showed overall superior prediction accuracy, whereas the Percolation model resulted in the best fit for mixtures containing microcrystalline cellulose in a range of 72%-48%. Both models were in good agreement at residuals below 3%.
authors.affiliation: Pharmaceutical Development, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Straße 65, 88397 Biberach, Germany; Department of Pharmaceutical Technology, University of Bonn, Gerhard-Domagk-Straße 3, 53121 Bonn, Germany.
authors.forename: Robert
authors.initials: R
authors.lastname: Schmidtke
authors.affiliation: Pharmaceutical Development, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Straße 65, 88397 Biberach, Germany.
authors.forename: Daniela
authors.initials: D
authors.lastname: Schröder
authors.affiliation: Pharmaceutical Development, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Straße 65, 88397 Biberach, Germany.
authors.forename: Judith
authors.initials: J
authors.lastname: Menth
authors.affiliation: Pharmaceutical Development, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Straße 65, 88397 Biberach, Germany.
authors.forename: Andrea
authors.initials: A
authors.lastname: Staab
authors.affiliation: Pharmaceutical Development, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Straße 65, 88397 Biberach, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Braun
authors.affiliation: Department of Pharmaceutical Technology, University of Bonn, Gerhard-Domagk-Straße 3, 53121 Bonn, Germany. Electronic address: kgwagner@uni-bonn.de.
authors.forename: Karl G
authors.initials: KG
authors.lastname: Wagner
mesh_terms: D002482:Cellulose / Q000737:chemistry; D004339:Drug Compounding; D005079:Excipients / Q000737:chemistry; D007785:Lactose / Q000737:chemistry; D008962:Models, Theoretical; D011208:Powders / Q000737:chemistry*; D011312:Pressure; D013607:Tablets / Q000737:chemistry*
chemical_list: D005079:Excipients; D011208:Powders; D013607:Tablets; D002482:Cellulose; D007785:Lactose; C109691:microcrystalline cellulose
keywords: Compression; Kawakita; Percolation theory; Prediction; Relative density; Solid fraction