Material properties play a significant role in pharmaceutical processing. In the present study, a novel approach is used to determine solid fraction (SF) based on a direct measurement (DM) of the apparent volume of a sample. The sample was scanned with low intensity laser beams that integrate the sample thickness across the surface (area) and quantitate the apparent volume. The SF by DM method was compared against that obtained by volume displacement (VD) and manual measurement methods. SF was determined by all three methods for formulations of Avicel DG, lactose and a 1:1 mixture of the two. The results from DM method and variability were comparable to that obtained by VD method. The manual method provided lower and more variable results. The DM method was able to differentiate between SF of different ribbon and tablet formulations and at varying force levels. Tracking SF of compacts during tablet development can help in setting acceptable specifications and to understand material deformation behavior during compression. Further, the results of the study indicate that the DM method using laser scan technique was suitable for routine testing of SF of roller compacted ribbons and compressed tablets.

译文

:材料特性在药物加工中起着重要作用。在本研究中,一种新颖的方法用于基于样品表观体积的直接测量(DM)来确定固体分数(SF)。用低强度激光束扫描样品,该激光束对整个表面(区域)的样品厚度进行积分并确定表观体积。将通过DM方法获得的SF与通过体积位移(VD)和手动测量方法获得的SF进行比较。通过Avicel DG,乳糖和两者的1:1混合物的所有三种方法测定SF。 DM方法和变异性的结果与VD方法可比。手动方法提供的结果更低且更多。 DM方法能够区分不同色带和片剂配方的SF,并以不同的力水平进行区分。在片剂开发过程中跟踪压坯的SF有助于设置可接受的规格并了解压缩过程中的材料变形行为。此外,研究结果表明,使用激光扫描技术的DM方法适用于辊压压实色带和压片的SF的常规测试。

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