Jannin V, Bérard V, N'Diaye A, Andrès C, Pourcelot Y
Pharmaceutical Development Laboratory, Gattefossé S.A., BP 603 69804 Saint-Priest Cedex, France.
Int J Pharm. 2003 Aug 27;262(1-2):39-45. doi: 10.1016/s0378-5173(03)00316-8.
Compritol 888 ATO is used as a lubricant in oral solid dosage formulations. It can also be used as a hot melt coating agent sprayed onto a powder. In this study, we compare the lubricant performance of Compritol 888 ATO either used by classical blending or by hot melt coating onto Lactopress by compression tests. In physical mix, the Compritol concentration does not affect the compressibility. The same compressibility is obtained with lactose coated by 0.5 or 1% of Compritol, but a higher compressibility can be observed with 2 and 3%. Cohesiveness of lactose depends on the process: hot melt coating induces a decrease of tablet tensile strength. In terms of forces transmission during compression phase and axial ejection pressures, Compritol used by hot melt coating allows for a concentration of 0.5% to directly obtain the lubricant performance of 3% of Compritol used by blending. These results suggest that the hot melt coating process induces an homogeneous repartition of the lubricant on the lactose surface, contrary to classical blending procedure. Thus, lubrication by hot melt coating seems to be a very efficient procedure. It could be used specifically for large surface area particulate systems producing a lot of friction.
Compritol 888 ATO用作口服固体制剂中的润滑剂。它也可用作喷涂在粉末上的热熔包衣剂。在本研究中，我们通过压缩试验比较了Compritol 888 ATO通过传统混合或热熔包衣在Lactopress上使用时的润滑性能。在物理混合中，Compritol的浓度不影响可压缩性。用0.5%或1%的Compritol包衣的乳糖可获得相同的可压缩性，但2%和3%时可观察到更高的可压缩性。乳糖的内聚性取决于工艺：热熔包衣会导致片剂抗张强度降低。就压缩阶段的力传递和轴向顶出压力而言，通过热熔包衣使用的Compritol在浓度为0.5%时可直接获得通过混合使用3%的Compritol时的润滑性能。这些结果表明，与传统混合工艺相反，热熔包衣工艺可使润滑剂在乳糖表面均匀分布。因此，热熔包衣润滑似乎是一种非常有效的工艺。它可专门用于产生大量摩擦的大表面积颗粒系统。
