Malladi Jaya, Sidik Kurex, Wu Sutan, McCann Ryan, Dougherty Jeffrey, Parab Prakash, Carragher Thomas
a Drug Product Science and Technology, Bristol-Myers Squibb , New Brunswick , NJ , USA.
b Nonclinical Biostatistics, Global Biometrics Sciences, Research and Development, Bristol-Myers Squibb , Princeton , NJ , USA.
Pharm Dev Technol. 2017 Mar;22(2):246-255. doi: 10.1080/10837450.2016.1219370. Epub 2016 Oct 4.
Tablet hardness, a measure of the breaking force of a tablet, is based on numerous factors. These include the shape of the tablet and the mode of the application of force. For instance, when a pentagonal-shaped tablet was tested with a traditional hardness tester with flat platens, there was a large variation in hardness measurements. This was due to the propensity of vertices of the tablet to crush, referred to as an "improper break". This article describes a novel approach to measure the hardness of pentagonal-shaped tablets using modified platens. The modified platens have more uniform loading than flat platens. This is because they reduce loading on the vertex of the pentagon and apply forces on tablet edges to generate reproducible tablet fracture. The robustness of modified platens was assessed using a series of studies, which included feasibility and Gauge Repeatability & Reproducibility (R&R) studies. A key finding was that improper breaks, generated frequently with a traditional hardness tester using flat platens, were eliminated. The Gauge R&R study revealed that the tablets tested with novel platens generated consistent values in hardness measurements, independent of batch, hardness level, and day of testing, operator and tablet dosage strength.
片剂硬度是衡量片剂断裂力的指标，它受多种因素影响。这些因素包括片剂的形状和施加力的方式。例如，当使用带有平板的传统硬度测试仪测试五边形片剂时，硬度测量值存在很大差异。这是由于片剂的顶点容易被压碎，即所谓的“不适当断裂”。本文介绍了一种使用改良平板测量五边形片剂硬度的新方法。改良平板的加载比平板更均匀。这是因为它们减少了五边形顶点上的载荷，并在片剂边缘施加力以产生可重复的片剂断裂。使用一系列研究评估了改良平板的稳健性，其中包括可行性研究以及量具重复性和再现性（R&R）研究。一个关键发现是，使用带有平板的传统硬度测试仪经常产生的不适当断裂被消除了。量具R&R研究表明，使用新型平板测试的片剂在硬度测量中产生了一致的值，与批次、硬度水平、测试日期、操作员和片剂剂量强度无关。
