title: Compaction of functionalized calcium carbonate, a porous and crystalline microparticulate material with a lamellar surface.
abstract: In the present study, we aimed to characterize the compressibility and compactibility of the novel pharmaceutical excipient, functionalized calcium carbonate (FCC). We studied three FCC modifications and compared the values for compressibility and compactibility with mannitol, microcrystalline cellulose (MCC), and ground calcium carbonate (CC 330) as well as mixtures of paracetamol and MCC or FCC at drug loads of 0%, 25%, 50%, 75%, and 100% (w/w). We used Heckel analysis, modified Heckel analysis, and Leuenberger analysis to characterize the compaction and compression behavior of the mixtures. Compaction analysis of FCC showed this material to markedly differ from ground calcium carbonate, exhibiting properties, i.e. plastic deformability, similar to those of MCC. This effect was attributed to the highly lamellar structure of FCC particles whose thickness is of the order of a single crystal unit cell. According to Leuenberger parameters, we concluded that FCC-based tablet formulations had mechanical properties equal or superior to those formulated with MCC. FCC tablets with high tensile strength were obtained already at low compressive pressures. Owing to these favorable properties (i.e. marked tensile strength and porosity), FCC promises to be suitable for the preparation of solid dosage forms.
authors.affiliation: Division of Pharmaceutical Technology, Department of Pharmaceutical Sciences, University of Basel, Klingelbergstrasse 50, CH-4056 Basel, Switzerland. Electronic address: tanja.stirnimann@unibas.ch.
authors.forename: Tanja
authors.initials: T
authors.lastname: Stirnimann
authors.affiliation: Division of Pharmaceutical Technology, Department of Pharmaceutical Sciences, University of Basel, Klingelbergstrasse 50, CH-4056 Basel, Switzerland. Electronic address: susanna.atria@stud.unibas.ch.
authors.forename: Susanna
authors.initials: S
authors.lastname: Atria
authors.affiliation: Division of Pharmaceutical Technology, Department of Pharmaceutical Sciences, University of Basel, Klingelbergstrasse 50, CH-4056 Basel, Switzerland.
authors.forename: Joachim
authors.initials: J
authors.lastname: Schoelkopf
authors.affiliation: Omya International AG, R&D Minerals and Surface Chemistry, Baslerstrasse 42, 4665 Oftringen, Switzerland; Aalto University, School ofChemical Technology, P.O. Box 16300, FI-00076 Aalto, Finland. Electronic address: patrick.gane@omya.com.
authors.forename: Patrick A C
authors.initials: PA
authors.lastname: Gane
authors.affiliation: Division of Pharmaceutical Technology, Department of Pharmaceutical Sciences, University of Basel, Klingelbergstrasse 50, CH-4056 Basel, Switzerland. Electronic address: rainer.alles@unibas.ch.
authors.forename: Rainer
authors.initials: R
authors.lastname: Alles
authors.affiliation: Division of Pharmaceutical Technology, Department of Pharmaceutical Sciences, University of Basel, Klingelbergstrasse 50, CH-4056 Basel, Switzerland. Electronic address: joerg.huwyler@unibas.ch.
authors.forename: Jörg
authors.initials: J
authors.lastname: Huwyler
authors.affiliation: Division of Pharmaceutical Technology, Department of Pharmaceutical Sciences, University of Basel, Klingelbergstrasse 50, CH-4056 Basel, Switzerland. Electronic address: maxim.puchkov@unibas.ch.
authors.forename: Maxim
authors.initials: M
authors.lastname: Puchkov
mesh_terms: D000082:Acetaminophen / Q000737:chemistry; D002119:Calcium Carbonate / Q000737:chemistry*; D002482:Cellulose / Q000737:chemistry; D003460:Crystallization; D005079:Excipients / Q000737:chemistry*; D008353:Mannitol / Q000737:chemistry; D016062:Porosity; D013499:Surface Properties; D013607:Tablets; D013718:Tensile Strength
chemical_list: D005079:Excipients; D013607:Tablets; D000082:Acetaminophen; D008353:Mannitol; D002482:Cellulose; D002119:Calcium Carbonate; C109691:microcrystalline cellulose
keywords: Compaction behavior; Contact surface; Lamellar surface; Leuenberger equation; Mercury porosimetry; Tensile strength