The surface layer of pharmaceutical compacts: the role of the punch surface and its impact on the mechanical properties of the compacts.
During pharmaceutical compaction, the interaction between the punch and the powder determines the formation and the aspect of the surface of the compact. In industry, the properties of the punch surface, which play a key role in this interaction, are sometimes changed by fixing an intermediate layer onto the punch to prevent sticking problems. In this article, the case of a polymer insert layer was studied. Firstly, sugar spheres were compacted with and without the polymer insert fixed onto the punches. After compaction with uncovered punches, the surface particles, which had been subjected to high deformation, were flattened on one side. However, it was observed, using confocal X-ray microfluorescence, that this kind of deformation was limited to the surface and that the bulk particles, which underwent a more isotropic deformation, still exhibited an approximately round shape. Secondly, the influence of the surface structure on the mechanical properties of the compacts was studied. The indentation hardness and the tensile strength of compacts of microcrystalline cellulose (MCC) and anhydrous calcium phosphate (aCP) were studied. No differences were found for the compacts of MCC produced with the two kinds of punches, but the compacts of aCP obtained with uncovered punches presented a higher hardness and a higher tensile strength than those obtained with covered punches.
Univ. Paris-Sud, EA 401, Matériaux et Santé, 92296 Châtenay Malabry, France.
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Mazel
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Busignies
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Diarra
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Reiche
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Tchoreloff
D002130:Calcium Phosphates / Q000737:chemistry; D002241:Carbohydrates / Q000737:chemistry; D002482:Cellulose / Q000737:chemistry; D004339:Drug Compounding; D005079:Excipients / Q000737:chemistry*; D006244:Hardness; D008855:Microscopy, Electron, Scanning; D011140:Polyurethanes / Q000737:chemistry; D011208:Powders / Q000737:chemistry*; D011312:Pressure; D013229:Stearic Acids / Q000737:chemistry; D013499:Surface Properties; D013718:Tensile Strength
D002130:Calcium Phosphates; D002241:Carbohydrates; D005079:Excipients; D011140:Polyurethanes; D011208:Powders; D013229:Stearic Acids; C031183:stearic acid; D002482:Cellulose; C020243:calcium phosphate; C109691:microcrystalline cellulose