Univ. Paris-Sud, EA 401, Matériaux et Santé, 92296 Châtenay Malabry, France.
Int J Pharm. 2013 Feb 14;442(1-2):42-8. doi: 10.1016/j.ijpharm.2012.08.005. Epub 2012 Aug 8.
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.
在药物压缩过程中，冲头和粉末之间的相互作用决定了压片的形成和表面的形态。在工业中，冲头表面的特性在这种相互作用中起着关键作用，有时通过在冲头上固定中间层来防止粘连问题，从而改变冲头表面的特性。在本文中，研究了聚合物插入层的情况。首先，用和不用固定在冲头上的聚合物插入层对糖球进行了压缩。用未覆盖的冲头进行压缩后，一侧经历了高变形的表面颗粒被压平。然而，使用共焦 X 射线微荧光发现，这种变形仅限于表面，而经历了更各向同性变形的体相颗粒仍然呈现大致圆形。其次，研究了表面结构对压片机械性能的影响。研究了微晶纤维素（MCC）和无水磷酸钙（aCP）压片的压痕硬度和拉伸强度。用两种冲头生产的 MCC 压片没有发现差异，但未覆盖冲头生产的 aCP 压片的硬度和拉伸强度均高于覆盖冲头生产的压片。
