期刊
INTERNATIONAL JOURNAL OF PHARMACEUTICS
卷 466, 期 1-2, 页码 266-275出版社
ELSEVIER SCIENCE BV
DOI: 10.1016/j.ijpharm.2014.03.027
关键词
Contact surface; Lamellar surface; Tensile strength; Mercury porosimetry; Leuenberger equation; Compaction behavior
资金
- Omya International AG
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. (C) 2014 Published by Elsevier B.V.
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