Shah A C, Mlodozeniec A R
J Pharm Sci. 1977 Oct;66(10):1377-8. doi: 10.1002/jps.2600661006.
A mathematical expression for tablet hardness was related to lubricant mixing by considering increases in the surface coverage with prolonged mixing time. The duration of lubricant mixing significantly changed the apparent bulk volume of the mix, ejection force during tableting, hardness, and disintegration and dissolution properties of tablets. These findings may provide some rationale for the changes in processing characteristics and properties of finished drug products often encountered in the scale-up of solid dosage formulations. Several lubrication mechanisms are discussed in connection with the duration of mixing effects and scanning microscopy studies.
通过考虑随着混合时间延长表面覆盖率的增加,得出了片剂硬度与润滑剂混合之间的数学表达式。润滑剂混合的持续时间显著改变了混合物的表观堆积体积、压片过程中的顶出力、硬度以及片剂的崩解和溶解特性。这些发现可能为固体剂型放大生产中经常遇到的成品药物加工特性和性质的变化提供一些理论依据。结合混合效果的持续时间和扫描显微镜研究,讨论了几种润滑机制。